Clinical trials programme
The collective landscape of academia-industry clinical trials is undergoing a period of transformation in response to the recent O’Shaughnessy and Tickell reviews.
Birmingham – as a prominent hub for clinical trials – is spearheading this change with a programme of work aimed at reducing bureaucracy and driving efficiencies in clinical trials and research delivery across BHP.
This ambitious project will enable us to build a community of knowledge, expertise and resource, improving the experience of research teams and facilitating access to a diverse range of patients.
Our focus is on academic clinical trials sponsored or led by a BHP member which involve at least one other BHP organisation. By addressing overarching processes and systems, we aim to positively impact the setup of commercial clinical trials and academic studies led from outside BHP.
Our aim is to harmonise the setup of academic clinical trials led and delivered across Birmingham Health Partners – from initial concept through to first patient recruited – reducing the overall time taken to bring high-impact innovation to patients in our region
Explore our programme of work
Principal aim
To be a national leader in clinical trials, bringing high-impact innovation to patients in our region, quicker
Key objectives
- To reduce bureaucracy and harmonise the set-up of clinical trials across BHP
- To reduce the overall time taken to deliver clinical trials to patients
Key performance indicators (KPIs)
- Reduce study set-up times
- Reduce time from request to contract execution
- Improve communication and understanding during grant development stage
- Enhance the experience of those navigating (and facilitating) the process
- Improve trust, transparency and collaboration
Partners have demonstrated a high level of commitment and enthusiasm for the programme, which is sponsored by board member Sir David Nicholson. The project builds on the work of BHP’s Clinical Trials working group – established in 2018 by Professor Pam Kearns – which highlighted a number of opportunities to increase efficiency and cut red tape. Prof Kearns continues to play a key role in the project’s leadership team.
The programme is led by Amy Smith, Senior Programme Lead who brings considerable experience in clinical trials across multiple BHP NHS Trusts and NIHR Infrastructure, she is supported by a Peer Group, bringing together a wealth of extensive knowledge and expertise, providing programme leadership on behalf of partner organisations.
Our representatives are:
Birmingham and Solihull Mental Health NHS Foundation Trust: Katie Williams, Research Governance Manager
Birmingham Women’s and Children’s NHS Foundation Trust: Liz Adey, Head of Research & Development
The Royal Orthopaedic Hospital NHS Foundation Trust: Gareth Stephens, Head of Research, Audit and Development
Sandwell and West Birmingham NHS Trust: Kelly Hard, Head of Research & Development
University Hospitals Birmingham NHS Foundation Trust: Dr Sarah Pountain, Head of Research Governance
Aston University: Sally Puzey, Director of Research Services
University of Birmingham:
- Sonia Fox, Deputy Director of Operations – Cancer Research UK Clinical Trials Unit (CRCTU)
- Dr Margaret Grant, Director of Operation – Birmingham Clinical Trials Unit (BCTU)
- Sam Hickman, Head of Research Support – College of Medical and Dental Sciences
- Birgit Whitman, Assistant Director – Research Strategy and Services Division
BHP Research FIRST: Dr Kate Fletcher, Head of Research FIRST
Commenting on the launch of the project, BHP board sponsor Sir David Nicholson said:
“This pivotal initiative is based on BHP’s shared belief that all patients should have the opportunity to take part in research, and the knowledge that research-active healthcare organisations perform better. We are all committed to working together to reduce bureaucracy and duplication of effort in clinical trials through this project, which will offer patients access to trials sooner and ensure innovations reach the clinic more quickly. The fantastic diversity of our regional population also means that our research, and the commercial innovations which result from it, will be applicable nationally and globally.”
Achieved:
- Senior Programme Lead commenced in post; programme brief, objectives, metrics and governance structure established
- Co-created a forum with the Clinical Research Network West Midlands, bringing together project leads undertaking similar projects and sharing regular updates on project outputs/ plans. It aims to reduce duplication and support wider dissemination of learning, supporting the national strategy to improve study setup times for all sites.
- Established a task and finish group to specifically focus on tools and processes to support during the grant application and pre-award stage
- Completed a survey to understand the current experience of researchers and facilitators, and gather their input on areas for improvement
In progress:
- Developing and extending the suite of BHP model agreements, aiming to reduce negotiation time
- Establishing a data collection system
- Development of tools to enable consistent approaches to grant applications
- Recommendations for site setup processes
- Evaluating opportunities for digital transformation of processes
Please contact Amy Smith, Senior Programme Lead, for more information: a.smith.23@bham.ac.uk