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Wellcome – HRB Clinical Research facility at St James’s Hospital

The Wellcome HRB CRF (CRF) is embedded in St James’s Hospital and is central to the clinical research activity taking place on campus. The CRF supports and conducts a wide range of studies from observational to complex clinical trials and medical device studies across all phases. The CRF includes a high spec research Pharmacy

The CRF has approximately 20 staff including a Clinical Director, Associate Directors, Program Manager, Assistant Director of Nursing, Research Pharmacist, Quality and Regulatory Affairs Manager, Research Nurses, Research Assistants, Data Manager and Administration staff. This highly specialized team work under a rigorous quality system that meets international standards (ICH-GCP) and has successfully completed Health Product Regulatory Authority Inspections.

The CRF can provide a bespoke service depending on your needs, we are a solution driven unit supporting investigators, sponsors and patients every step of the way through their research journey.

Martina Hennessy

Clinical Research Facility 2nd floor H & H Building Dublin D08 Ireland

Areas of Expertise

  • Cell therapy (Allogeneic)
  • Cell Therapy (Autologous)
  • Gene Therapy (non-viral)
  • Gene therapy (viral)

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Leeds Biomedical Research Centre

Clinical Research Facility Opens Its Doors to Patients at Leeds Teaching Hospitals NHS Trust

Leeds CRF Team

Today (Monday 17th February 2020) patients at Leeds Teaching Hospitals NHS Trust (LTHT) taking part in clinical research trials will undergo treatment within the new £3.2 million purpose-built St James’s University Hospital Clinical Research Facility (CRF) for the first time. The CRF provides dedicated space and facilities for the care of patients participating in leading-edge clinical trials at LTHT.

Clinical trials are research studies involving people. They help NHS staff understand how to treat a particular illness using new drugs, therapies, techniques or technologies. Trials may benefit patients directly, or others like them, in the future. Patients who take part in a clinical trial may be one of the first people to benefit from a new treatment.

IMG 2422

Located within the Bexley Wing, the new CRF doubles the amount of space available for patients taking part in research, providing a more spacious, comfortable and better-equipped environment, and for the first time allowing overnight stays for research patients who need round the clock clinical monitoring. 

The treatment suite of 6 beds, 11 treatment chairs and one procedure room, ensures space for 18 patients who could all be participating in different trials at the same time. There are also dedicated research consulting rooms, alongside supportive clinical care space to deliver high-quality outpatient, day case and inpatient treatment and care.

The St James’s CRF was funded by LTHT (£3.2 million) with support from the University of Leeds, and additional funding provided by hospital charity Leeds Cares for specialist equipment (200k).

Professor Chris Twelves

Professor Chris Twelves, Professor of Clinical Cancer Pharmacology and Oncology at the University of Leeds and Director of the Leeds Clinical Research Facility said “This state of the art, purpose-built facility will transform the way patients take part in clinical trials. It will not only enhance the patient experience but allow us to undertake trials on a different level to before.”

Dr Jacqueline Andrews, Director of Research & Innovation at LTHT said: “The opening of the new CRF will bring tremendous benefits to our patients at LTHT. It has been demonstrated that patients treated at research-active hospitals have better outcomes. We are committed to expanding our research facilities throughout the Trust to ensure all our patients have the opportunity to get involved in research.”

Leeds Cares Managing Director Andrew Cratchley said: “As the official charity partner of Leeds Teaching Hospitals, Leeds Cares supports NHS staff to deliver the best care for patients and their families. We’re incredibly grateful to our donors and supporters for helping us fund equipment for the new Clinical Research Facility. By funding such projects, we’re helping to ensure that patients and their families continue to benefit from the best possible care.” Want to be part of Leeds Research?  Click here  to find out how you can get involved!

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Study protocol for the St James's Hospital, Tallaght University Hospital, Trinity College Dublin Allied Researchers' (STTAR) Bioresource for COVID-19

Laura o'doherty.

1 Department of Infectious Diseases, St. James's Hospital, Dublin, Dublin, Ireland

2 Clinical Research Facility, St. James's Hospital, Dublin, Dublin, Ireland

3 Department of Clinical Medicine, School of Medicine, Trinity Translational Medicine Institute, Trinity College Dublin, Dublin, Ireland

Stuart Hendricken Phelan

Nicole wood, sorcha o'brien, jacklyn sui.

4 Department of Immunology, St James's Hospital, Dublin, Ireland

Cian Mangan

Fergal howley, siobhan o'regan, noor adeebah mohamed razif, ciara conlan, samuel holohan, fara salleh, liam townsend, gerard hughes, derval reidy, alberto sanz, emma connolly, andrea kelly, conor reddy, siobhan gargan, eamon breen, heike hawerkamp, ignacio martin-loeches.

5 Department of Intensive Care Medicine, St James's Hospital, Dublin, Ireland

Anne Marie McLaughlin

Aideen long, orla shiels, padraic fallon, martina hennessy, roman romero-ortuno, ciaran bannan, anna rose prior.

6 Departments of Clinical Chemistry and Laboratory Medicine, Dublin 24 and School of Medicine, Tallaght University Hospital, Trinity College Dublin, Dublin, Ireland

Ana Rakovac

William mccormack, ross mcmanus, seamus donnelly.

7 Department of Respiratory Medicine, Tallaght University Hospital, Dublin, Ireland

Colm Bergin

Mark little, clíona ní cheallaigh, niall conlon, associated data, underlying data.

No data are associated with this article.

Extended data

Zenodo: Study Protocol for the St James's Hospital, Tallaght University Hospital, Trinity College Dublin Allied Researchers' (STTAR) Bioresource for COVID-19, https://doi.org/10.5281/zenodo.6278295 .

This project contains the following extended data:

  • - Case Report Form, Informed Consent Form, Convalescent Report Form Online.docx

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Peer Review Summary

Background : The current coronavirus disease 2019 (COVID-19) pandemic began in Ireland with the first confirmed positive case in March 2020. In the early stages of the pandemic clinicians and researchers in two affiliated Dublin hospitals identified the need for a COVID-19 biobanking initiative to support and enhance research into the disease. Through large scale analysis of clinical, regional, and genetic characteristics of COVID-19 patients, biobanks have helped identify, and so protect, at risk patient groups The STTAR Bioresource has been created to collect and store data and linked biological samples from patients with SARS-CoV-2 infection and healthy and disease controls.

Aim : The primary objective of this study is to build a biobank, to understand the clinical characteristics and natural history of COVID-19 infection with the long-term goal of research into improved disease understanding, diagnostic tests and treatments.

Methods : This is a prospective dual-site cohort study across two tertiary acute university teaching hospitals. Patients are recruited from inpatient wards or outpatient clinics. Patients with confirmed COVID-19 infection as well as healthy and specific disease control groups are recruited.  Biological samples are collected and a case report form detailing demographic and medical background is entered into the bespoke secure online Dendrite database.

Impact : The results of this study will be used to inform national and international strategy on health service provision and disease management related to COVID-19. In common with other biobanks, study end points  evolve over time as new research questions emerge. They currently include patient survival, occurrence of severe complications of the disease or its therapy, occurrence of persistent symptoms following recovery from the acute illness and vaccine responses.

Introduction

Coronavirus disease 2019 (COVID-19) is a novel, infectious, multi-system disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 1 The first case was confirmed in Ireland on the 26 th of February 2020 2 . On the 11 th of March 2020 the WHO declared COVID-19 to be a pandemic and since then this infectious disease and the effects of control measures have impacted on every aspect of normal life 3 . Clinical features of the disease vary greatly, ranging from severe respiratory failure and death to mild cough or no symptoms 4 . In the early stages of the pandemic clinicians from a range of disciplines in St.James’s Hospital (SJH) and Tallaght University Hospital (TUH), alongside researchers in Trinity College Dublin (TCD) identified the need for a biobanking initiative to support timely research into COVID-19. This led to the creation of the St James’s and Tallaght University Hospital and Trinity College Dublin Allied Researchers (STTAR) Bioresource for COVID-19.

The aim of the STTAR Bioresource is to collect and store data and linked biological samples from St. James’s Hospital and Tallaght University Hospital patients with SARS-CoV-2 infection and healthy and disease controls and to use this resource within strict ethical and governance frameworks to support high quality research and inform national and international strategy on COVID-19 ( Image 1 ).

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To achieve this goal, we have:

  • Established and maintained a clinical database of COVID-19 infected patients
  • Collected and stored biological samples (serum, plasma, PaxGene, leucocytes, DNA samples and saliva) and used these in concert with clinical data
  • Compared differences in clinical characteristics and outcomes between those infected with COVID-19 and those in healthy and disease control groups.
  • Built a powerful bespoke database linking granular clinical data with novel research data
  • Shared coded samples and data with research groups to support local, national and international research initiatives.

As this novel disease continues to evolve, we have focused on understanding three aspects of COVID-19. The first is determinants of disease severity, including patient characteristics (e.g. age, sex, socio-economic status, co-morbidities), immunological features (e.g. immune cell phenotype) and alterations in proteins involved in coagulation. The second key area of interest for the group is patient recovery post COVID-19 disease and the study of prolonged symptoms. We aim to follow patients from admission through to follow up visits in the recovery stage of their illness. The third key area of interest is the immune response to COVID vaccines (including post-third dose/booster) across patient groups and healthy controls. Breakthrough infections post-vaccination or prior infection are a current focus of interest, and recruitment of these patients has been prioritised to enable analysis and research of these cases to begin without delay.

Study protocol

Study design.

This is a prospective dual-site cohort study across two tertiary acute university teaching hospitals. The primary objective of this study is to build a biobank, to understand the clinical characteristics and natural history of COVID-19 infection with the long-term goal of research into improved disease understanding, diagnostic tests and treatments. We utilised a variety of existing infrastructures to support recruitment, clinical data collection, sample collection and storage, including the Department of Immunology, the Department of Infectious Diseases and the Wellcome Trust Clinical Research Facility at SJH and the Department of Respiratory Medicine in Tallaght University Hospital; and the Trinity Translational Medicine Institute (TTMI) to store and process these samples.

In common with other biobanks, study end points evolve over time as new research questions emerge. They currently include patient survival, occurrence of severe complications of the disease or its therapy, occurrence of persistent symptoms following recovery from the acute illness and vaccine responses.

Research timeline

The start date for this study was April 2020 with the first recruit on the 27th April 2020. The duration of the bioresource has been open-ended and will evolve with time and need. Use of existing infrastructure and re-allocation of clinical and research staff allowed the early start of the study.

Study setting

The STTAR Bioresource is situated in St James’s Hospital and Tallaght University Hospital in Dublin, Ireland. Our hospitals have a broad catchment area including parts of Kildare, South and West Dublin. Patients are referred for inpatient COVID-19 care by their general practitioner, emergency ambulance services or by self-presenting to the emergency department. Each hospital also receives inpatient transfers from secondary hospitals linked to them in the Dublin Midlands Hospitals Group 5 .

In both sites, all patients are tested for COVID-19 on admission to hospital, regardless of their presenting illness. Staff members are also tested by the hospital if they develop symptoms suggestive of COVID-19 infection or in the case of hospital outbreaks. Moreover, patients may be referred to the hospital ‘long COVID’ follow-up outpatient clinic, for example from general practitioners (GPs) or following discharge after an admission for COVID-19 infection. These three patient groups – inpatients, hospital staff, and ‘long COVID’ outpatients as well as healthy and disease controls– were eligible for recruitment and inclusion in the Bioresource study population.

Study population

People with acute covid-19.

Inpatients with polymerase chain reaction (PCR) confirmed SARS-CoV-2 in the two recruiting acute hospital sites are invited to take part. Hospital staff with confirmed diagnoses of COVID-19 disease are also recruited. Further samples and data are collected at clinical follow-up in post-COVID clinics.

Control group

Staff, patients, and members of the public who do not have acute COVID-19 are invited to participate. In order to facilitate effective matching to cases, controls from a range of ages and varying socio-economic status are sought. Control patients’ COVID-19 infection and vaccination status are recorded. Disease controls will be recruited from patients admitted with other respiratory infections (e.g. influenza).

Other specific disease groups

Patients with polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection with underlying complex immunodeficiency disorders and vasculitis are invited to take part in smaller subgroup studies. Their results are compared to the general COVID-19 positive study group and to the control group. There are no specific exclusion criteria.

Sample and data collection

Time points.

A practical approach to recruitment was put in place during the various waves of the pandemic. It is acknowledged by the study team that there is value in both samples and high-quality patient data. In general, samples are taken the morning following diagnosis or admission during the routine phlebotomy round. The study team monitors the patient record and where there is a clinical deterioration marked by an increase in Fi02 or a requirement for additional ventilatory support or intensive care assessment, a second sample set is sought. Further samples at discharge or convalescence are sought. For practical reasons samples at each time point are not always available or required. Emphasis on the relative importance of each time point is dictated by the steering group in response to the pandemic environment. Convalescent patients are also recruited from clinics during attendance for routine clinical care ( Image 2 ).

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Sampling protocol: patients with incident COVID-19

New patients with positive SARS-CoV-2 tests are identified by the STTAR Bioresource Study team from daily internal communications of new positive SARS-CoV-2 PCR tests and COVID-19 ward admissions. Patients are approached for informed consent and provided with the STTAR Bioresource patient information leaflet. The project and use of the samples are explained in detail, with a specific focus on genetic aspects of the study. All patients are given an opportunity to review documentation and ask questions prior to signing the informed consent form. Patients are made aware that there are no consequences to not being involved in the study, informed that they can specifically opt out of genetic aspects of the study and that they can withdraw their data and samples from the study at any time. In cases where informed consent from a patient is not possible, next of kin assent is sought in line with our ethics approvals. If/when they regain capacity, we will approach them for retrospective consent.

A unique bioresource study ID is assigned to each consented patient and recorded in recruitment logs. Completed paper informed consent forms for both hospital sites are held centrally and securely in the Wellcome Trust Clinical Research Facility.

To minimise patient discomfort and reduce the numbers of contacts, study blood samples are taken at the same time as routine clinical samples. A case report form (Appendix A, Case Report Form) detailing demographic and medical background is completed and saliva samples taken by the research nurse obtaining consent (Appendix B, Informed Consent Form). This data is then entered to the secure Dendrite database. Blood samples in SJH are transported to the central processing lab after phlebotomy, where they are retrieved directly by a member of the bioresource team, for immediate processing in the TTMI laboratory. In TUH, blood and saliva samples are taken by the TUH bioresource research nurse and placed in a morning courier to TTMI. If genetics is not consented to, Paxgene samples are not taken from the patient.

Withdrawal procedure

If the patient decides to withdraw from the study at any stage, the research team member documents this decision clearly in the patient’s medical notes and CRF detailing the reason if known. A withdrawal form is then completed.

Participants have the following options:

  • ○ No further access: This means that no further data or samples will be collected. The participant will no longer be contacted. However, the Registry and Biobank will still have permission to use, store and share information and samples collected up until this date.
  • ○ No further use: This means that no further data or samples will be collected. The participant will no longer be contacted. Samples held by the Biobank will be destroyed. Data held on the patient will be deleted. Researchers who have received samples and data will be contacted to request that unused samples and data be destroyed. Research results from data that has been analysed will continue to be used.

Sample processing

Samples are received by the STTAR team in a bag labelled ‘COVID BIORESOURCE’. Each bag contains 6 sample types and 8 tubes – the maximum volume collected is 46mls (see Table 1 and Image 3 ).

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  • SARS-CoV-2 has been classified as a risk group 3 biological agent. Laboratories carrying out non propagative research and development work can, subject to risk assessment, carry out work at minimum containment level 2 6 .
  • Following local risk assessment the STTAR processing team work at containment level 3 in a CL2 facility. Periodic review of the risk assessment is carried out as delegated by the appropriate Health and Safety Committee.
  • For samples 1–3, 4 – 6 aliquot tubes (0.5 ml Sarstedt micro tubes) are labelled with Study ID, timepoint, sample type and aliquot number.
  • EDTA spun pellet and RNA Paxgene tubes are simply labelled with the Study ID and Timepoint number as they remain in their original tubes.
  • Samples 1–3 are centrifuged @ 3,400 RPM @ room temperature for 10 minutes and the plasma / serum stored in Sarstedt 0.5 ml Micro tubes with cap 72.730.007. 250–300 microliters of sample are added to each labelled micro- tube
  • All Aliquots and PAXGENE and EDTA are labelled with Study ID and entered into the biobank
  • ○ Samples for functional studies are collected from TTMI by study staff
  • ○ 6mls Lithium Heparin are processed as per the relevant protocol from the investigator lab for fresh sample analysis
  • ○ The remaining (18mls Lithium Heparin) are processed using SepMate – PBMC is separated and split into one aliquot for immediate functional studies (if needed) and one aliquot for freezing.

PBMC isolation using SepMate method

  • 15mL of Lymphoprep is loaded into the bottom of SepMate 50 tube.
  • Blood is pooled from collection tubes into 50mL tube and diluted 1:2 with PBS.
  • The diluted blood (up to 35mL) is overlayed on lymphoprep while keeping the tube upright and then spun at 1200g for 10mins with break on.
  • The top layer is then poured into a new 50mL tube and suspension is spun at 400g for 7mins with break on.
  • The supernatant is discarded, and pellet resuspended in 10mL PBS (small sample taken for counting) and spun again at 400g for 7mins with break on.
  • Supernatant is again discarded and pellet resuspended in appropriate volume of cryoprotective media (10%DMSO/90%heat inactivated FBS).
  • Samples are divided into aliquots (1ml × 1×10 7 cells/ml) and labelled with study ID for immediate use or for cryopreservation

Cryopreservation

All steps should be performed immediately with minimal pipetting.

  • 1. Prior to centrifuging cells for cryopreservation the number of vials to be stored down and the amount of freezing media required to achieve 1mL volumes at a final cell concentration of 1 x 10 7 cells/mL is calculated.
  • 2. All vials are labelled with liquid nitrogen safe labels with the study ID, sample type and vial number.
  • 3. Freezing media is stored at 2–8°C until time of use.
  • 4. Samples are centrifuged at 400g for 7 minutes, the supernatant discarded and tube gently flicked to resuspend the cell pellet.
  • 5. 1mL of cold cryoprotective media (10%DMSO/90% heat inactivated FBS) (2–8°C) per 1 × 10 7 cells is added and gently mixed.
  • 6. 1mL aliquots are placed into labelled cryovials and then into the freezing container (at an appropriate temperature) which is then stored at -80°C at the TTMI in the STTAR Bioresource Biobank.

Documentation in sample spreadsheet

Study number, sample type, aliquot number, position and row are documented in the COVID BIORESOURCE 2020 spreadsheet. Information on all samples received for processing and the aliquots generated, including Study ID, aliquot ID, processing date and location of aliquot storage are logged on the STTAR Biobank Patient Recruitment and Sample Log.

Data and sample access

Applications for access to clinical data or samples from the STTAR Bioresource are considered by a designated committee and granted for specific reasons. Successful applications have been made to date by researchers investigating COVID-related anosmia, ‘long COVID’ symptoms and COVID-19 patients’ cardiovascular risk profiles. Applications are discussed by the STTAR steering group and either approved, held pending further information or rejected. There is a process for appeal in the context of sample rejection. The STTAR steering group makes its decisions based on the quality and feasibility of an application. Applications for biological samples are also assessed with reference to efficient use of the finite sample resource and avoidance of duplication of research effort.

Dispensing of samples from biobank

TTMI biobank staff are notified by the Steering committee Chair that a sample request has been approved and the samples are dispensed to the recipient. All samples dispensed from the biobank are logged on STTAR COVID-19 Biobank Patient Recruitment and Sample Log and the following information is recorded:

  • Recipient of sample
  • Date of dispensing
  • Volume of sample given

These are interim processes pending implementation of Module Bio Biobank Information Management System .

Clinical data collection

Patient characteristics (e.g. age, sex, level of education, co-morbidities, pre-admission medication) and features of COVID-19 infection (e.g. date of symptom onset, oxygen requirement, COVID-19 treatment, requirement for admission to intensive care, radiological findings, results of blood tests) are extracted from the electronic patient record in SJH and from the paper medical chart in TUH by clinical research nurses and/or clinical research fellow after completion of the acute inpatient episode. A subset of variables are recorded for the date of blood sampling for storage in the bioresource including symptoms, diseases severity oxygen requirement and medication. and (e.g. symptomatology, disease severity) Peak severity is defined using the WHO clinical progression score. Clinical data quality control is done by the PIs on 10% of cases selected at random.

The case report form (Appendix A) is completed by the research nurse on paper or using tablet computers with the patient at the time of recruitment (or as soon thereafter as possible) and captures additional features not routinely recorded in the patient record including patient level of education, country of origin, smoking/alcohol history, social exclusion status (homelessness, injecting drug use, having been in prison), COVID-19 vaccination status, accommodation, employment status and travel history among other fields. Pre-morbid frailty status is assessed by the clinical research nurse using the clinical frailty score 8 . Patient self-perceived social status is measured using the MacArthur Scale or ‘ladder score’ 9 , 10 .

Patient recovery is characterised using a case report form (Appendix C, Convalescent Case Report Form) completed at the time of clinical outpatient review, on paper or ideally directly on the clinical database. This includes back-to-work status, six-minute walk test results (conducted by our physiotherapy team) and Chalder fatigue scores. The six minute walk tests is an exercise test that measures distance walked over six minutes. It is a measure of functional status or fitness.

Clinical data is stored under a unique participant identifier on a bespoke STTAR Bioresource Clinical Data database on Dendrite, a secure electronic data capture (EDC) web platform for building and managing online databases and surveys. The Dendrite database operates on multiple-access levels and only the Principal Investigator (PI), Research Nurse and Clinical Research Fellow have complete access to the database and permission to modify. The STTAR Bioresource Clinical Data database is hosted by St James’s Hospital and security and access permissions are managed by the hospital’s information management system team. The database is protected behind host and institutional firewalls. The data controller for St. James’s Hospital patient data is St. James’s Hospital and for Tallaght University Hospital patient data held on the Dendrite database hosted by SJH, both institutions are data controllers. Inter institutional data sharing agreements between St. James’s Hospital, Tallaght University Hospital and Trinity College Dublin are in place.

Coded biological samples are processed and stored centrally at the STTAR Bioresource and archived by the biobank technician using industry standard Freezerworks software which only the biobank technician and lead study PI have access to. The registry database is shared with TCD IT service providers who manage their security and access permissions. This database is also periodically backed up on an external third-party server located in Dublin.

Experimental data collection

TCD researchers who generate experimental data deriving from analysis of STTAR Bioresource samples or data, store this in dedicated TCD SharePoint folders, which is the preferred storage solution of the university. Each researcher has their own access-controlled folder. These data include spreadsheets (excel, CSV, .xlsx), Graphpad Prism files (.pzfx), flow cytometry files (.fcs), word documents, image files (.jpeg, .png, .ndpi), PowerPoint files (.pptx), transcriptomic data files (.cel). All coded experimental data pertaining to the STTAR Bioresource study is stored on TCD’s Microsoft OneDrive service. OneDrive is Microsoft's cloud-based file storage service, which allows syncing and sharing of files between computers and mobile devices and is the cloud computing service of choice of TCD. Data hosted on OneDrive is securely hosted by Microsoft in Europe in compliance with relevant legislation (see TCD Data Protection Procedural Guidelines).

Ethical approval and safety measures

The STTAR Bioresource study has been granted ethical approval by the SJH/TUH Joint Research and Ethics Committee, (JREC 2020-05 List 19). This committee operates in compliance with and is constituted in accordance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 & ICH GCP guidelines. Health Research Consent Declaration Committee conditional approval was also obtained (HRCDC 20-012-AF1/COV). A data protection impact assessment and review was performed in each centre.

Statistical analysis

Descriptive analysis of group characteristics includes number and proportion of cases for categorical variables, mean and standard deviation (SD) for normally distributed continuous variables, and median and inter-quartile range (IQR) for non-normally distributed continuous variables. When examining associations between COVID-19 disease severity and for example serum inflammatory markers, statistical methods are employed to account for confounding pre-existing diseases, e.g. multivariable logistic regression. Control groups of both vaccinated and unvaccinated age matched patients will be used to help validate results.

Study governance ( Image 4 )

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Governance Structure. SFI = Science Foundation Ireland, SJH = St James’s Hospital, TUH = Tallaght University Hospital, TTMI = Trinity Translational Medicine Institute.  

Patient and public involvement

Patient and public involvement (PPI) is an important and meaningful part of research 11 . It has been argued that the profound and collective impact of the COVID-19 pandemic throughout society makes PPI more important than ever 12 , 13 . Accordingly, the authors have begun the process of recruiting patient representatives to the STTAR Bioresource committee. In addition, the STTAR Bioresource study will have a dedicated website to help disseminate its results to a wider audience.

Study status

The STTAR Bioresource study continues to recruit new study participants from our two hospital sites as well as following up our existing participants. Studies looking at the relationship between socio-economic status and COVID-19 antibody levels post vaccination and another looking at the effects of COVID-19 infection on menstruation cycles of female participants are among the many projects underway at present. The steering committee of this study is continuing to welcome proposals and applications from researchers across our study sites.

Dissemination

A fundamental mission of the STTAR Bioresource study is the timely and open-access dissemination of study results. This is achieved through publication of study results in open access journals and discussion at hospital grand rounds. Audits of data access are a fundamental part of this reporting procedure. All research outputs are reported in real time in open access formats and shared with the relevant stakeholders in line with the HRB joint statement on sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak. Detailed processes for data sharing, dissemination and exploitation are described in the data sharing agreement.

This research was prompted by a public health crisis that has impacted healthcare systems, economies, and societies globally. This study’s inclusive recruitment methods mean it involves patients from all socioeconomic backgrounds, all age groups, and all degrees of COVID-19 disease severity. The findings of the STTAR Bioresource study are relevant to policy and practice in the future care of patients with COVID-19 disease 13 – 15 .

The STTAR COVID Bioresource biobank was established despite limited financial and practical resources and has been, since its inception, reliant on the good will of St James’s (SJH) and Tallaght University Hospitals, Wellcome Trust Clinical Research Facility (SJH) and funding from Science Foundation Ireland as a Strategic Partnership Project (SFI-SPP).

Through large scale analysis of clinical, regional and genetic characteristics of COVID-19 patients, biobanks have helped identify, and so protect, at risk patient groups 16 , 17 . Twenty European Union states have come together to form the Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC) 18 . BBMRI-ERIC is a pan-European initiative providing one-stop access to the preserved biological samples of participating countries for research purposes. This pre-existing infrastructure allowed for the timely mobilisation of research communities across Europe in response to the COVID-19 pandemic 19 . The lack of formal policy and procedures relating to biobanking in Ireland posed challenges to the establishment of a de novo COVID-19 biobank 20 . There is currently no national biobank in Ireland and Ireland is not represented in BBMRI-ERIC. Calls for the establishment of a similar resource in Ireland conducive to high-impact research and data-sharing across research sites led to the announcement of funding of a National Irish COVID Biobank (NICB) by the HRB supported by Department of Health in July 2021 21 . The NICB will incorporate STTAR as well as other Irish COVID Biobanks.

This ambitious project will coordinate and harmonise data and sample collection across Irish sites and establish a unified governance framework in line with international biobanking standards. STTAR investigators have taken on leadership roles in this collaborative endeavour. As well as driving COVID-19 research at a national level, the complex process of setting up the NICB will inform non-cancer biobanking strategies in other disease areas into the future.

Strengths of this study

Patients began being recruited to the study in April 2020, only short weeks after the first confirmed case of COVID-19 nationally. This early recruitment has allowed for an invaluable look at the first group of inpatients in Ireland with the disease. Over 1000 patients have been recruited to this study so far. This large study number increases the statistical value of any results. Detailed demographic data are being collected including patient occupation, number of people living in patients’ home, number of people sharing a bedroom with patient, home place (own accommodation, nursing home resident, homeless shelter resident) among other details. This allows us to analyse in detail a patient’s premorbid level of social deprivation, something not analysed in previous similar biobanks. The biobank participants are recruited from inpatient wards, intensive care units and outpatient staff groups. This allows for a wide range of disease severity (asymptomatic to critically unwell), disease acquisition (community, occupation and hospital-acquired) and age groups to be studied. Large numbers of healthcare workers are recruited to this study. This uniquely vulnerable group will be compared to the usual inpatient group. Looking more closely at infected health care workers may help inform future infection control procedures. Over 100 control patients have been recruited to the study. Vaccination status as well as usual case report form demographic details are collected. These healthy age matched control patients will allow comparison of results from studies conducted within STTAR Bioresource.

Limitations of this study

Most patients who are enrolled in this study are hospital inpatients. Patients hospitalised with COVID-19 likely have severe disease requiring high level care. Recruiting most of our patients from the inpatient cohort means we may have a biased sample population and miss those with asymptomatic or mild disease. We follow our recruited patients in post COVID-19 outpatient clinics. Those who cancel their appointments due to resolution of symptoms are more difficult to capture in our study and so there may be a bias towards long COVID symptoms in those we see.

Data availability

[version 1; peer review: 2 approved]

Funding Statement

The STTAR bioresource had been funded to date mainly by money from SFI , a Strategic Partnership Program grant that was co-funded by AIB: 20/SPP/3685

Reviewer response for version 1

Mary keogan.

1 Department of Clinical Immunology, Beaumont Hospital, Dublin, Ireland

2 Royal College of Surgeons in Ireland, Dublin, Ireland

This paper describes the inception and rapid establishment of a collaborative biobanking resource, established within 2 months of the first confirmed COVID case worldwide. The collaboration involved 2 model 4, large teaching hospitals in Dublin, together with academic partners from Trinity College Dublin, and allied research institutes. This paper focuses on the steps undertaken to establish the biobank, and alludes to some of the research in progress which utilises this resource, but clearly, these individual studies will be disseminated in a specialty specific way.

This study demonstrates the rapidity in which existing infrastructure can be mobilised to develop a high quality biobank, in response to a public health crisis, despite limited funding. The value of this biobank is greatly enhanced because of the early commencement of storage of material. The large range of disease severity, patient settings and detail of demographics and social factors additionally increase the value of this resource.

This paper provides a systematic description of the processes involved in establishing a biobank, and will be of value to others considering the establishment of such a resource, regardless of disease area.

There are ISO standards for Biobanking (ISO 20387:2018), and the need for compliance with such standards by funding and regulatory agencies is expected to increase over time. While the authors are to be congratulated for rapid mobilisation, and the effectiveness of the STTAR biobank to date, the relevance of this paper internationally would be enhanced by including a gap analysis of compliance with the relevant ISO standards.

Is the study design appropriate for the research question?

Is the rationale for, and objectives of, the study clearly described?

Are sufficient details of the methods provided to allow replication by others?

Are the datasets clearly presented in a useable and accessible format?

Not applicable

Reviewer Expertise:

Clinical Immunology; transplantation; Service delivery

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Luuk B. Hilbrands

1 Department of Nephrology, Radboud University Medical Center (Radboudumc), Nijmegen, The Netherlands

This protocol describes a very well designed biobank and concurrent registry for COVID-19 patients, and healthy and disease specific controls.

There is clear argumentation for the creation of the biobank and registry and the methods are described in sufficient detail.

As recognized by the investigators, patients included in this project are mainly in-hospital patients and healthcare workers, which carries the risk of bias. If possible, it would be valuable to have access to national or regional registries of all COVID-19 patients to estimate the type and magnitude of selection bias. Similarly, the coupling of the study registry to a national registry of COVID-19 vaccination could provide more reliable data on the vaccination status of participants.

nephrology, immunology, kidney transplantation

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Hospital Professional News

Ireland’s first-ever clinical study of CAR-T cell therapy for treating multiple myeloma opens

CARTITUDE-5 provides suitable newly diagnosed patients in Ireland with a new treatment  option and is now recruiting patients 

Ireland’s first ever clinical trial for a cell therapy to treat multiple myeloma, a type of blood cancer, is now open at St James’s Hospital, Dublin, where eligible study participants may access a new treatment option for myeloma. CARTITUDE-5, a multicentre global study, seeks to evaluate the efficacy and safety of CAR-T as a frontline therapy in people newly diagnosed with this rare form of blood cancer for whom a stem cell transplant is not planned as an initial  treatment. 1

clinical research facility st james

Chimeric antigen receptor (CAR)-T cell therapy is a highly personalised technology whereby a  patient’s own T-cells can be re-programmed to target and kill cancer cells. It involves collecting a type of white blood cells, called T-cells, from a patient’s blood and genetically altering them in a lab before transfusing them back into the patient to fight the cancer. 2

Multiple myeloma is an incurable form of blood cancer that starts in the bone marrow, most  commonly affecting people over the age of 65 and is more common in men than in women. 3 It is the  second most common blood cancer with approximately 2,200 people living with it in Ireland today and 352 people newly diagnosed annually. 4 However, despite significant advances in treatment for multiple myeloma in recent years, high unmet need remains. 5

clinical research facility st james

CARTITUDE-5 is the first study to evaluate CAR-T as a frontline therapy in newly diagnosed  patients. The trial is being led by Dr Larry Bacon, clinical lead for Ireland’s National Adult CAR-T Centre, located at St James’s Hospital. The study will be performed in collaboration with the Wellcome HRB Clinical Research Facility at St James’s Hospital which is providing specialised infrastructure, nursing and research pharmacy support.

Speaking about the launch of the study today, Dr Larry Bacon said: “The National Adult CAR-T Centre is spearheading the introduction of cell therapies, which are transforming how blood cancer is  treated in Ireland. CAR-T therapy is a lifeline for blood cancer patients. Through the CARTITUDE-5  trial, we will offer suitable newly diagnosed multiple myeloma patients access to a potentially life saving CAR-T therapy. We look forward to delivering this specialised therapy to multiple myeloma  patients as part of the trial.”

Professor Martina Hennessy, consultant clinical pharmacologist and Director of the Wellcome HRB Clinical Research facility at St James’s Hospital , said: “ Access to clinical trials of novel and advanced therapies such as CAR-T are critical to generating new knowledge and changing the outcomes for patients with myeloma. While the outcome of any clinical trial is uncertain, we commend Irish patients and their families for their willingness to participate in this important work.  St James’s Hospital has always played a major role in cancer clinical trials and this study is a natural evolution into a dynamic new era for cancer therapy”.

Dr Patrick Hayden, Consultant haematologist and clinical lead for the Myeloma Service at St  James’s Hospital, said: “Cancer research is vital to improve the prevention, detection, and treatment  of cancer. This trial represents a significant development for the treatment of multiple myeloma. CAR-T therapy has already demonstrated its ability to achieve very good responses among multiple  myeloma patients at an advanced stage who have undergone multiple treatments previously. The CARTITUDE-5 study aims to assess whether outcomes could be improved by bringing CAR-T therapy  forward in the patient’s myeloma experience rather than waiting until they are at an advanced stage. It’s great to bring this innovative cell therapy to Irish patients through this trial.” 

Geraldine Walpole, Chairperson of Multiple Myeloma Ireland , said: “This is a welcome development  for newly diagnosed multiple myeloma patients in Ireland. Participation in the CARTITUDE-5 clinical trial may provide access to a much-needed cutting-edge treatment option. We hope this trial will ultimately contribute towards better treatment regimens for patients living with multiple myeloma.”  

clinical research facility st james

This study has been made possible in Ireland thanks to a major collaboration between the  Haematology, Oncology and Palliative Care (HOPe) Directorate and medical, nursing, cryobiology laboratory, pharmacy and corporate teams at St James’s Hospital and the Trinity St James’s Cancer Institute, along with industry, the Department of Health, HPRA and the NCCP.

The CARTITUDE-5 study is now open for enrolment and healthcare professionals should contact  [email protected] for queries regarding patient participation.

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Leeds Institute of Medical Research at St James's

Leeds institute of medical research at st james's university hospital.

Based at St. James’s University Hospital in Leeds, the Leeds Institute of Medical Research (LIMR) investigates the causes and medical treatment of disease at the level of molecules, cells, patients and populations. Our medical research interests include the genetics, genomics and cell biology of disease, haematology and immunology, cancer research (from basic biology through to clinical trials and outcomes research), gastroenterology, surgery and pathology and the use and integration of big data sets into these problems.

LIMR is the largest research institute in the School of Medicine. We have around 90 academic staff and approximately 400 research staff and students. Most of our activity is undertaken at the St. James's University Hospital campus, with some staff based on the main University campus and at the Leeds General Infirmary.

LIMR brings together scientists and clinicians to focus on excellence in science and how this can benefit the health of patients. As well as our research, we are committed to excellence in student education. Our academics contribute to teaching on the University of Leeds MBChB programme (undergraduate medical degree), the postgraduate Molecular Medicine programme, also based at St James’s, and many other courses across the School of Medicine and the wider University.

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Cancer biology and therapy msc, medicine mres, molecular medicine msc, our research.

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Low-cost drugs provide hope for bowel cancer prevention

Prevention is key in this common disease and it's fascinating that the combination of widely available and relatively cheap drugs seemed to have such an impact. Professor David Crossman, NIHR

Both aspirin and a purified omega-3, called EPA, reduce the number of pre-cancerous polyps in patients found to be at high risk of developing bowel cancer, according to new research conducted by Leeds Institute of Medical Research and St James's.

Postgraduate research opportunities

The Institute encourages researchers to approach us with their ideas for research projects. If we have funded/non-funded research degree opportunities or scholarships available we will advertise them on the Faculty's postgraduate research opportunities directory .

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Ascension St. John Clinical Research

Ascension St. John Clinical Research

Google maps location of Ascension St. John Clinical Research

1725 E. 19th. St. Suite 701 Tulsa,  OK  74104

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St. John Clinical Research coordinates and conducts clinical trials by equipping investigators with an efficient infrastructure, a committed research staff and operational expertise. With research support in varying capacities, the department helps determine the safety and effectiveness of devices, diagnostic products, medications and treatment regimens intended for patient use. It also supports the research mission of Ascension St. John by facilitating research funding, managing funded projects and educating research personnel on current state, federal and funding agency-specific research policies and procedures. Investigators are physicians trained and credentialed for clinical trials in their respective fields.

Full-time registered nurse research coordinators dedicate 100 percent of their time to trials, and clinical staff are specially trained to perform research procedures and collect data as mandated by study protocol and federal, state and local regulations and guidelines. Regulatory oversight and ethics submissions are managed by a regulatory specialist dedicated to clinical research compliance.

All research staff receive training in human subject protections through the Collaborative Institutional Training Initiative (CITI) Program every three years and the National Institutes of Health annually. Physicians and other staff comprise the roster of Ascension St. John’s Institutional Review Board (IRB), a committee that performs ethical reviews of proposed research. The IRB is registered with the U.S. Department of Health & Human Services, which grants Ascension St. John a Federal wide Assurance and, therefore, federal support for research involving human subjects trials. If you are interested in participating in a clinical trial, please contact the Ascension St. John Clinical Research Institute at 918-744-3426 or [email protected] .

The Clinical Research Institute coordinates and conducts a variety of clinical trials, including ones for the following therapeutic areas:

  • Cardiovascular diseases
  • Dermatology
  • Endocrinology
  • Gastroenterology
  • Genetic diseases
  • Healthy volunteers
  • Hepatology (liver, pancreas and gall bladder)
  • Infections and infectious diseases
  • Internal medicine
  • Nutrition and weight loss
  • Orthopedics and orthopedic surgery
  • Pulmonary and respiratory diseases
  • Trauma (emergency, injury and surgery)
  • Vaccines In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators.

These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients or to no intervention. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful or no different than available alternatives (including no intervention). The investigators try to determine the safety and effectiveness of the intervention by measuring certain outcomes in the participants.

Active Trials

The following clinical trials by St. John Health System are open for patient enrollment. For a list of all active trials, click here .

St. John Heart and Vascular Center:

  • ECLIPSE – A study to evaluate the treatment strategies for severe coronary artery calcification: orbital atherectomy vs. conventional angioplasty technique prior to implantation of drug-eluting stents. The divide is the Diamondback 360® Coronary Orbital Atherectomy System (OAS) 1.25 mm classic crown.
  • GEMINI – A drug study to compare the safety of rivaroxaban with acetylsalicylic acid, in addition to either clopidogrel or ticagrelor therapy for acute coronary syndrome.
  • GRAFTMASTER – A device study to assess a coronary stent graft system for the treatment of free perforations defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts more than 2.75 mm in diameter.
  • LOW-RISK TAVR – A device study to measure the feasibilty of transcatheter aortic valve replacement in low-risk patients with symptomatic, severe aortic stenosis. This study is currently allowing only enrollment in the bicuspid arm.
  • PIONEER HF – A drug study to assess the effect of in-hospital initiation of sacubitril/valsartan compared with enalapril.
  • TAVR – A device study to measure the quality of care for patients receiving transcatheter valve therapy. St. John Neurosurgery
  • CORDIS ENTERPRISE HUD – A device study to assess a vascular reconstruction system.
  • DYSTONIA HUD – A device study required by the U.S. Food & Drug Administration to allow patients to undergo deep brain stimulation surgery for the treatment of dystonia.
  • LVIS HUD – A device study to evaluate the safety and benefits of the low-profile visualized intraluminal support (LVIS and LVIS Jr.) devices from MicroVention Inc. when used to facilitate endovascular coiling of unruptured, wide-necked, intracranial aneurysms with bare platinum embolization coils.
  • WINGSPAN HUD – A device study to assess the Wingspan Stent System with Gateway PTA Balloon Catheter. St. John Neurology/Stroke Center
  • ARAMIS – A study to address real-world anticoagulant management issues in stroke registry.
  • CREST 2 – A study on carotid revascularization and medical management for asymptomatic carotid stenosis.
  • MaRISS – A study to evaluate treatment options for patients with mild and rapidly improving stroke symptoms.

St. John Trauma Center

  • ARDS – A Phase I study comparing outcomes in trauma-specific refractory acute respiratory distress syndrome (ARDS) using a high-frequency oscillatory ventilator versus “proning” as a salvage protocol.
  • RE-VERSal – A Phase III, case series study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

St. John Breast Center

  • MAMMOGRAM CAD* – An observational study to improve the detection of breast cancer using a novel computer-assisted diagnosis system and analytic approach applied to mammography. *These clinical trials are conducted in collaboration with the national Ascension Clinical Research Institute, which brings together research sites at Ascension ministries across the country to share resources and expertise. Participation Research needs both researchers and volunteers. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of clinical research that helps produce reliable results. Participation criteria may include age, gender, type and stage of disease, treatment history, and other medical conditions. A participant must qualify for the study before being consented for a clinical trial. The ethical and legal codes that govern medical practice also apply to clinical trials. A participant should evaluate the potential risks and benefits before participating. The details of your care during a study will be reviewed during a consultation with an RN research coordinator.

During a consultation, the following information is reviewed with the candidate:

  • Why researchers believe the experimental treatment may be effective
  • Whether the experimental treatment has been previously tested
  • Kinds of tests involved, if any
  • Possible risks, side effects and benefits and how they compare with current treatment
  • Participant’s responsibilities and how long the study will last
  • Follow-up care after study
  • Evaluation methods for experimental treatment

Candidates should ask questions, like:

  • What can I expect if I participate?
  • What are the possible risks?
  • Will the research help me personally?
  • Can I leave the study at any time?
  • Will it cost me anything?

Participants' care is often covered by insurance, including Medicare and Medicaid. Please check with your provider. If you're interested in participating in a clinical trial, please contact the St. John Clinical Research Institute at 918-744-3426  or  [email protected] .

Sponsor/Industry Resources

The St. John Clinical Research Institute provides research support to several "centers of excellence" within St. John Health System. Departments that often use Clinical Research Institute resources include:

  • St. John Center for Women’s Health
  • St. John Heart and Vascular Center
  • St. John NeurosurgerySt. John Neurology/Stroke

St. John Trauma Center Scope of services include:

  • Phase IIb-IV drug trials
  • Clinical safety and efficacy
  • Dose ranging and definition
  • Efficacy and safety in special populations
  • Labeling and claims support
  • Post-marketing surveillance Device trials
  • Classes I-III
  • Premarket approval
  • Investigational device exemption
  • Humanitarian device exemption Ancillary services
  • Protocol preparation
  • Study design
  • Source document form design
  • IRB preparation and submission
  • Budget analysis and negotiation
  • Contract review
  • -80° freezer

Investigational drug/device storage, a double locked entry system and a laboratory for processing research specimens with freezer and refrigerator storage are located on site at the Clinical Research Institute.

St James CRF

No Vacancies are present.

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Cancer Research at TSJCI

Harnessing Fundamental, Translational and Clinical Research for the Benefit of Cancer Patients and their Families

Trinity St James’s Cancer Institute (TSJCI) merges Ireland’s largest cancer treating academic health campus at St James’s hospital, with the research excellence of Trinity College Dublin, Ireland’s leading university.

Directed by Professor Lorraine O’Driscoll, TSJCI’s research is focussed on improving outcomes for people with cancer through innovative and ground-breaking fundamental, translational, and clinical research. Synergising the research of clinician and non-clinical researchers, and also informed by our patients’ representative group, this will be achieved via 4 interconnected Research Themes:

Theme 1: Cancer Prevention and Early Diagnosis Theme 2: Molecular and Precision Oncology Theme 3: Cancer Immunology, and Theme 4: Cancer Survivorship and Supportive Care, leading to improvements in health status and quality of life for people in Ireland and beyond. 

For further information on research at TSJCI, please contact:  Prof. Lorraine O’Driscoll, TSJCI Research Lead [email protected]

If you wish to submit a research funding proposal to an external funding body (national, international or charity source) or wish to find out about funding opportunities you may be eligible to apply for, please contact Dr Patricia Doherty, Senior Research Programme Officer:  [email protected]

Research Banner

Cancer Prevention

Cancer is now the most common chronic diseases in developed countries worldwide. In Ireland alone, excluding non-melanoma skin cancer, it is estimated that by 2040 cancer cases will increase by 81% for females and 108% for males. In addition, Ireland is following the global trend towards an ageing demographic that will result in a corresponding increase in the incidence of cancer.

Molecular and Precision Oncology

The primary goal of TSJCI’s Molecular and Precision Oncology Theme is to contribute vital molecular insights that facilitate a better understanding of cancer biology and may be translated into more refined diagnostics for cancer detection and new treatments for patients with cancer. This theme is also key to supporting the application of rational, disease and patient-focused approaches to cancer therapy.

Cancer Immunology

Our goal is to harness the critical mass of our internationally renowned academic and clinical researchers in the field of immunology and cancer. This cancer centre, the first in Ireland, brings together our significant expertise and ambition to develop better, more effective treatments leading to better outcomes for all our cancer patients.

Cancer Survivorship and Wellbeing

Over the past 25 years, cancer survival rates have improved significantly both in Ireland and internationally as a result of enhanced clinical care and emerging treatment modalities. It is estimated that the number of cancer survivors is set to double over the next 25 years. A cancer survivor is described as someone living with and beyond cancer. Cancer survivorship is wide-ranging and encompasses prevention and surveillance for new and recurrent cancers, health promotion, surveillance and management of physical, psychological and social effects, coordination and management of chronic conditions, psycho-oncology, self-management, supportive care and social prescribing.

Cancer research is a Trinity priority research theme, based on the quality of research which has been generated by its academics.

Cancer research is a Trinity priority research theme, based on the quality of research which has been generated by its academics.

IMAGES

  1. Our Facilities

    clinical research facility st james

  2. Our Facilities

    clinical research facility st james

  3. Wellcome-HRB Clinical Research Facility

    clinical research facility st james

  4. Clinical research infrastructure

    clinical research facility st james

  5. PPT

    clinical research facility st james

  6. Wellcome-HRB Clinical Research Facility

    clinical research facility st james

VIDEO

  1. Medical Research Scotland Academy 2024 Week 3

  2. Welcome to the Nottingham Clinical Research Facility

  3. Clinical Research Facility 2016 LTHTR LCFT

  4. MAHSC Inaugural Lectures: MAHSC Honorary Clinical Chairs

COMMENTS

  1. Wellcome-HRB Clinical Research Facility

    The Wellcome-HRB Clinical Research Facility at St. James's Hospital is a state of the art research facility supporting world class research across a wide range of clinical conditions. Our Impact. Since opening in May 2013, the CRF has grown from strength to strength supporting a wide variety of clinical trials and studies Exciting milestones ...

  2. Our Facilities

    All clinical areas within the unit are equipped with calibrated patient monitoring systems such as ECG machine, dynamaps. We are located off the hospital corridor and have full access to hospital services - chute system to main pathology laboratory, security, hospital IT system etc. The HRB-CRF at St James's hospital provides protected ...

  3. Overview

    The Wellcome HRB CRF (CRF) is fully embedded in St James's Hospital and is central to the clinical research activity taking place on campus. Located at the heart of St James's Hospital it supports and conducts a wide range of studies from observational studies to complex clinical trials. Currently the CRF employs approximately 20 staff ...

  4. Wellcome

    The Wellcome HRB CRF (CRF) is embedded in St James's Hospital and is central to the clinical research activity taking place on campus. The CRF supports and conducts a wide range of studies from observational to complex clinical trials and medical device studies across all phases. The CRF includes a high spec research Pharmacy

  5. Strategic Programme 2021

    The Strategic Programme 2021 - 2025 sets out a bold vision for St James's Hospital, offering a framework to achieve its ambitious goals. As Ireland's largest adult acute teaching hospital, our team of around 5,200 staff comprises a city within a city. The core values of St James's Hospital are to provide the best care to every patient ...

  6. St James's Hospital Research and Development Hub

    St James's Hospital announced the establishment of the new Research and Development Hub, in association with the on-site Wellcome Trust - HRB Clinical Research Facility. The new Research and Development Hub will support researchers in all aspects of their explorations, from their pursuit of grants through to publication and an increased ...

  7. Clinical Research Facility Opens Its Doors to Patients at Leeds

    The St James's CRF was funded by LTHT (£3.2 million) with support from the University of Leeds, and additional funding provided by hospital charity Leeds Cares for specialist equipment (200k). ... Professor of Clinical Cancer Pharmacology and Oncology at the University of Leeds and Director of the Leeds Clinical Research Facility said ...

  8. Study protocol for the St James's Hospital, Tallaght University

    The STTAR COVID Bioresource biobank was established despite limited financial and practical resources and has been, since its inception, reliant on the good will of St James's (SJH) and Tallaght University Hospitals, Wellcome Trust Clinical Research Facility (SJH) and funding from Science Foundation Ireland as a Strategic Partnership Project ...

  9. PDF Facility at St. James' Hospital

    The Wellcome Trust/HRB Clinical Research. Facility at St. James' Hospital. Professor Michael Gill, Director February 2015. Part of a Programme jointly funded by the Wellcome Trust and HRB. Components: -Dublin Centre for Clinical Research (DCCR) Network involving TCD, RCSI, UCD and Molecular Medicine Ireland (2009 - 2015) - funded by HRB.

  10. About Us

    St Luke's Radiation Oncology Network and the Wellcome Trust/HRB Clinical Research Facility are also situated on the site. The vision for St James's Hospital into the future is to be a leading healthcare organisation, nationally and internationally, and to improve health outcomes through collaboration and innovation.

  11. For Researchers

    It will also be reviewed by relevant sub-committees such as the Clinical Research Facility Operations Team or the Nursing Research Access Committee, if applicable. An R&I reference number is needed when applying to the SJH/TUH Joint Research Ethics Committee (JREC). You will receive this number once you submit an R&I application form.

  12. Clinical research facility opens its doors to patients at Leeds

    P atients at Leeds Teaching Hospitals NHS Trust (LTHT) taking part in clinical research trials will undergo treatment within the new £3.2 million purpose-built St James's University Hospital Clinic. The CRF provides dedicated space and facilities for the care of patients participating in leading edge clinical trials, some of which are being run by University of Leeds researchers.

  13. Clinical Trials and Studies

    Clinical Trials and Studies. We work principally with medical teams based at St James's Hospital but can also work with other affiliated hospitals. The Clinical Research Facility provides the expertise and infrastructure to support the delivery of clinical trials of new medicines, medical devices and observational type studies.

  14. clinical research facility

    clinical research facility

  15. Ireland's first-ever clinical study of CAR-T cell therapy for treating

    The trial is being led by Dr Larry Bacon, clinical lead for Ireland's National Adult CAR-T Centre, located at St James's Hospital. The study will be performed in collaboration with the Wellcome HRB Clinical Research Facility at St James's Hospital which is providing specialised infrastructure, nursing and research pharmacy support.

  16. Leeds Institute of Medical Research at St James's

    LIMR is the largest research institute in the School of Medicine. We have around 90 academic staff and approximately 400 research staff and students. Most of our activity is undertaken at the St. James's University Hospital campus, with some staff based on the main University campus and at the Leeds General Infirmary.

  17. Contact Information

    If you wish to make an enquiry to the St. James's Hospital CRF, then please use the contact form or the contact information listed on our website. Skip to the content. Directions; Contact; ... Wellcome-HRB Clinical Research Facility, H&H Building, Level 2, St James's Hospital, James's Street, Dublin 8, D08 A978

  18. Research Application Guidance

    For research based in SJH, ethics submissions should be made to the local ethics committee, which is the Tallaght Hospital / St James's Hospital JREC. For clinical trials, ethics applications can be made to any of the 12 Department of Health approved Research Ethics Committees around the country, including the Tallaght Hospital/ St James's ...

  19. Strategic Resources

    Clinical Research Facility. LBCAM. Smurfit Institute of Genetics. Panoz Institute. Useful Links. Make a donation; Pay your bill; COVID-19; Latest news; Patients. Blood Testing ... St James's Hospital James Street Dublin 8 Ireland D08 NHY1. Phone (01) 410 3000; Registered Charity Number: 20017583; Twitter; Facebook;

  20. Ascension St. John Clinical Research

    If you're interested in participating in a clinical trial, please contact the St. John Clinical Research Institute at 918-744-3426 or [email protected]. Sponsor/Industry Resources The St. John Clinical Research Institute provides research support to several "centers of excellence" within St. John Health System.

  21. Research

    Clinical research has the potential to help us expand our knowledge of human diseases, to prevent and treat illnesses, to promote health and improve patient care. Our research vision at St James's Hospital is to lead the way in innovative research which aims to positively change the trajectory of the lives of our patients and community.

  22. Vacancies

    Contact Us. +353 1 410 3900. [email protected]. Wellcome - HRB Clinical Research Facility, Wellcome - H&H Building, Level 2, St James's Hospital, James's Street, Dublin 8, Ireland.

  23. Research

    Directed by Professor Lorraine O'Driscoll, TSJCI's research is focussed on improving outcomes for people with cancer through innovative and ground-breaking fundamental, translational, and clinical research. Synergising the research of clinician and non-clinical researchers, and also informed by our patients' representative group, this ...