The Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI) was established in 2020 to support the development and delivery of novel therapeutics and medical devices in the UK, through advanced regulatory standards and tools.
A truly multidisciplinary intiative, CRSI brings together experts in medicinal science, health policy and management, clinical trial design, medical law and patient-reported outcomes research, from across BHP member organisations.
The Centre’s Lead for Artificial Intelligence, Professor Alastair Denniston, serves on the UK Government’s Regulatory Horizons Council – an independent expert committee, established to ensure that UK regulation keeps pace with innovation and enables it to thrive while safeguarding the public.
In July 2020, the Centre launched a major report – ‘Advancing Regulatory Science and Innovation in Healthcare’ – which called a coherent and specific national strategy for regulatory science. Click here to download the report as a pdf.
Its key research themes include:
- Patient-centred drug development
- AI in healthcare
- Accelerated access to medicines
- Real-world data collection
- Innovative trial design
- Medical technologies
Recent years have seen a rapid acceleration of discovery in fields such as personalised medicine, health data, AI, digital health and drug discovery. Alongside these developments, we are establishing novel methods of clinical trial design and growing the role of the patient in medical innovation - from Patient and Public Involvement and Engagement to Patient-Reported Outcomes Research.
To ensure the safe and effective use of these innovations however, it is vital that we are able to validate, evaluate and legislate at an equally swift pace. Here, cross-sector partnership working is critical if the UK is to achieve its Life Sciences Industrial Strategy objectives, enhance the growth of emerging markets and support the NHS with innovative therapies - all in the safest and most effective way for patients.
Regulatory science achieves this by bringing together multiple disciplines with one focus - ensuring the quality, safety and efficacy of new medicinal products throughout their lifetime: from drug discovery and clinical trials, to introduction and adoption in clinic.
The mission of the CRSI is to drive innovation in regulatory science to promote efficient, safe and cost-effective implementation of new therapies, for the benefit of patients and society.
It works to identify critical emerging challenges in UK regulatory science; prioritise strategic areas in which to develop regulatory standards; implement effective cross-sector training platforms; and design the UK-wide infrastructure needed to drive this agenda across a broad range of stakeholders.
The Centre's activity is broadly grouped into three pillars: policy development; research and innovation; and capacity building and education. In line with these pillars, CRSI will:
- Generate evidence to support advances in regulation
- Convene national and international debate between key stakeholders
- Provide training and support in regulatory science
- Develop international consensus-based guidance for healthcare in cutting-edge disciplines
The Centre also enables BHP to delivery effective, safe and affordable novel therapies to NHS patients through a well-resourced and coherent approach to R&D and regulation. Working through our established network, these therapies will benefit patients throughout the UK healthcare system.
The Centre leverages Birmingham Health Partners' established profile and expertise in several key areas:
- UK's only Centre for Patient-Reported Outcomes Research
- CONSORT-PRO guidelines for optimum reporting of randomised clinical trials
- SPIRIT-PRO guidance for trial protocol writers
- Home to the Birmingham Clinical Trials Unit and Cancer Research UK Clinical Trials Unit, which together form the Birmingham Centre for Clinical Trials - one of the largest clinical trials in existence
- Pioneers of innovative methodology in cancer trials
- SPIRIT-AI and CONSORT-AI - world-first international standards for reporting of clinical trials which utilise AI and machine learning
- Emerging area of influence in healthcare, cited in the NHSX report 'Artificial Intelligence: How to Get it Right'
Advanced therapies and precision medicine
- Strong links with the co-located Birmingham Precision Medicine Centre
- Home to the Midlands-Wales Advanced Therapy Treatment Centre
- Experienced in spinning out new companies
- Birmingham's Healthcare Technologies Institute leads research in new technologies and treatments - including encouraging better tissue healing and rehabilitation tools
- The Medical Devices Testing and Evaluation Centre (MD-TEC) supports medtech and life sciences enterprises with design and development, validation, human factors engineering, usability studies and regulatory compliance
- Birmingham hosts the Test Evaluation Research Group (TERG), an internationally recognised group producing and evaluating evidence on the performance of medical tests
- We work across the spectrum of test evaluation, from biological variability, through diagnostic accuracy and into decision–making and patient health impact
- New collaboration with ABPI will tackle Birmingham’s biggest health challenges
- Birmingham to lead ground-breaking research into patient experience of cell therapies
- Patients to benefit from new guidelines on AI in clinical trials
- Introducing Birmingham Precision Medicine Centre
- Regulation matters: CRSI AI expert appointed to UK’s new Regulatory Horizons Council
Centre Director and Academic Lead – Professor Melanie Calvert: firstname.lastname@example.org
Artificial Intelligence in Healthcare Theme Lead – Professor Alastair Denniston: A.Denniston@bham.ac.uk
Diagnostic Test Evaluation Theme Lead – Professor Jon Deeks: email@example.com
Administrative Contact – Dr Eliot Marston: firstname.lastname@example.org