Translational Clinical Research Delivery
Research FIRST
Research FIRST (Flexible Innovative Research Support Service) provides a flexible and innovate approach to supporting non-CTIMP research and other projects (for example, Clinical Audits, Service Evaluations and Management Databases).
Delivered through Birmingham Health Partners (BHP) and the Institute of Translational Medicine (ITM), the team provides expertise in Study Co-ordination, Database development (using REDCap) and Data Management. Complementing the existing research infrastructure across BHP, Research FIRST ensures that all projects are delivered to a high standard in a timely manner whilst complying with all relevant regulations and guidelines (including GCP, GDPR and individual sponsor’s Quality Management Systems).
Adopting an innovative and flexible approach, we can tailor our support to meet the needs of specific studies and Investigators, from providing access to REDCap only, right through to full management and delivery of the study. Over the past 18 months our portfolio has grown rapidly and we are supporting a wide range of projects across BHP. Some of our key projects include:
- The ELSA Study, screening for Type 1 Diabetes in children aged 3-13. The target is to recruit 20,000 children and recruitment has been phenomenal; we expect to achieve this number by the end of the year. Further funding to extend the recruitment to 40,000 children is being sought. www.elsadiabetes.nhs.uk
- The STRAVINSKY study (Stratification of Clinically
Vulnerable People for COVID-19 Risk Using Antibody Testing), a NIHR funded project, aims to establish if antibody testing can identify who remains at greatest risk of severe COVID-19 infection after vaccinations. Recruitment is ongoing and is expected to complete in 2025. - Although we work primarily with teams across BHP,
we also support projects from outside the Partners,
including other NHS Trusts and commercial companies. We welcome approaches from any interested parties to explore what support we may be able to provide.
www.birminghamhealthpartners.co.uk/forresearchers/our-research-first-service/
Cancer Research UK Clinical Trials Unit (CRCTU)
Drugs, Devices, Diagnostics and Biomarkers (D3B)
The CRCTU has a portfolio of non-cancer trials, and these are run through two teams –Drugs, Devices, Diagnostics and Biomarkers (D3B) and Inflammation, Advanced and Cellular Therapy (I-ACT).
The Drugs, Devices, Diagnostics and Biomarkers (D3B) collaborative was established in August 2016 to support design and delivery of high-quality, early phase translational research within Birmingham Health Partners (BHP). D3B is located at the heart of Birmingham’s Institute of Translational Medicine (ITM) with team members derived from Birmingham’s Cancer Research UK Clinical Trials Unit (CRCTU). D3B was created to support development of a research portfolio that aligned with the Government’s strategy for UK Life Sciences; this aims to provide patients with early access to novel treatments.
Non-cancer trials – University of Birmingham
Liberate:
IIH:
The Inflammation-Advanced and Cellular Therapy (I-ACT) team was formed in October 2018, and covers arange of different disease areas, including autoimmune liver conditions such as Primary Sclerosing Cholangitis and Autoimmune Hepatitis; Inflammatory Bowel Disease; Rheumatoid Arthritis; Sjogren’s Syndrome; COVID-19; and some cancer trials. The team specialises in academic initiated early phase trials (proof of concept through to Phase I and Phase II) with an innovative or complex trial design. Many of these trials involve novel compounds or advanced/ cellular therapies, with the majority being multi-centre trials in the UK.
The trial management team leader, Anna Rowe, has 15 years of experience in novel early phase clinical trials, including cell therapy trials. The team consists of Senior Trial Coordinators, Trial Coordinators and Trial Administrators, and contribute to funding applications, design, set up and ongoing management of these trials. I-ACT has a close working relationship with other teams within the Cancer Research Clinical Trials Unit (including Biostatistics) and other departments within
the University, such as the Centre for Patient Reported Outcomes.
The trials are linked to the Birmingham NIHR Biomedical Research Centre, the Innovate UK funded Midlands and Wales Advanced Therapy Treatment Centre, and the Kennedy Trust funded Arthritis Therapy Acceleration Program. Recent trial collaborations or funding success include PARIS (Janssen Research & Development); REACT (NIHR Efficacy and Mechanism Evaluation program); FARGO (LifeArc and PSC Support) and ACT2 (MRC Developmental pathway funding scheme).
Contact can be made via: I-ACT@trials.bham.ac.uk
The Translational Research Team (TRT) [Translational Research – University of Birmingham] and aligned Birmingham Drug Discovery Hub (BDDH) [University of Birmingham, Birmingham Drug Discovery Hub] work with University of Birmingham academics and clinical academics in their journey to understand and realise the potential real world impact of their medical / health research, and provide a framework of support to accelerate progress.
Since the team was established in 2019 with Welcome Institutional Translational Partnership Award (2019-2024) and MRC Confidence in Concept (2019-2023) funding outputs include:
- Translational Grant Support for a large number of external and internal applications, including institutional Welcome Translational Development Fund, MRC Confidence in Concept and most recently MRC Impact Acceleration Account projects.
- Internal Funding outputs include further funding, high impact research publications, patent applications, partnerships with industry and even formation of spin outs. Additionally, BDDH pump-primed projects have returned multimillion-£ investments, with some projects currently under due diligence review prior to spin out formation with support from industry.
- Collaborations have been facilitated through
management of a portfolio of over 350 projects enabling interdisciplinary match making of individuals and opportunities. - Access to Expertise has seen academics supported to meet with external consultants, in addition to internally funded projects (TDF/CiC/IAA) with Project Translation Groups actively chaired by such consultants.
- Training has supported a large number of attendees (PhD, postdoc, group leads, clinicians) at ~ 50 events, plus bimonthly Birmingham Drug Discovery Hub / Club events.
Going forward support may include:
- Translational grant support – as former researchers, our translational research managers have experience in working with a range of funders and industry partners, and are able to discuss how your project can be pitched to the right audience.
- Access to internally managed funds – the University of Birmingham MRC Impact Acceleration Account (Internal Research and Impact Funding (birmingham.ac.uk)) is actively managed through the team. Researchers are supported to develop and deliver projects beyond proof of concept to further validate before external funding is sought.
- Support for collaborations – using our translational research portfolio, we support the development of interdisciplinary collaborations. And have the ambition of building a more comprehensive range of Translational Research Innovation Networks. BDDH’s Drug Discovery Club will continue to bring together a community of interdisciplinary researchers across a range of drug discovery (disease agnostic) relevant fields.
- Opportunity match making with industry partners –
BDDH are facilitating productive interactions between a range of industry partners and researchers through proactive curation and management of a stratified research portfolio. - Access to expertise – as appropriate, we will provide
access to a diverse range of external consultants to
overcome project specific hurdles.
Contact us
UHB R&D Clinical Research Delivery
The Trust has a wide and varied research portfolio, with research activity undertaken across all Trust sites, CDGs and including at a management/corporate level. The portfolio consists of studies developed and led by Trust researchers as well as the Trust being a site for other organisations/institutions research. The delivery of our research activity is largely led and managed through speciality specific research teams and a core research delivery team; which support in the identification of research studies for our patients, the screening, recruitment and follow up of these patients. These teams are supported by research nurses/midwives/AHPS, trial co-ordinator’s, data managers.
The DHSC and NIHR acknowledge that the UK clinical research delivery system continues to face challenges in supporting the delivery of research post-pandemic. Their vision is anchored around five themes: sustainable and supported research workforce, clinical research embedded in the NHS, people centred research, streamlined, efficient and innovative research and research enabled by data and digital tools. All elements UHB is committed to support and deliver on; through the training and development of our staffs and researchers, links with partners such as BHP, PPIE and EDI work and our research. The DHSC’s The Recovery, Resilience and Growth programme is still focusing on supporting a research portfolio that was sustainable within the resource and capability within the NHS. As a Trust we continue to support to support our Trust Sponsored research portfolio to achieve this; working
with Chief Investigators to deliver to their research to key milestones and ensure the highest standards in patient safety and scientific integrity.
In line with the aims of the Lord O’Shaughnessy report, this we continue to monitor our Trust set up times, aligned to national process and guidance and have worked with commercial companies in the implementation of the national processes. Our study set up times, the time from receiving confirmation we have been selected as a research site for the trial to when we issue Trust approval for the study to commence, have reduced to 51 working days in 2023/24 (55 working days median 2022/23). We continue to monitor our set up times to ensure efficiency as well as monitoring our Sponsorship portfolio to support the DHSC’s The Recovery, Resilience and Growth programme.
Our research portfolio can be sub-categorised in several different ways:
- Observational or interventional (this includes novel therapies, device)
- Commercial or non-commercial
- NIHR portfolio (research that is included on the NIHR CRN portfolio adopted) or non-NIHR portfolio