Recent years have seen a rapid acceleration of discovery in fields such as artificial intelligence (AI), digital healthcare, personalised medicine, the use of real world data and drug discovery. Alongside these developments, we are establishing novel methods of clinical trial design, tackling bias and inequity 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 ensure that our ability to evaluate and regulate these innovations keeps pace. Here, cross-sector partnership working is critical if the UK is to achieve its Life Sciences Vision objectives, support the growth of emerging markets and accelerate innovative therapies and technologies in partnership with the NHS – all in the safest and most effective way for patients. 

Regulatory science achieves this by bringing together multiple disciplines to ensure the quality, safety, efficacy and equity of new medicines, devices and healthcare products throughout their lifetime: from discovery and clinical trials, to introduction and adoption in clinic – 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 deliver safe, effective, equitable and sustainable 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:

Patient-reported outcomes

• • • 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 

Clinical trials

• • • Home to the Birmingham Clinical Trials Unit, Cancer Research UK Clinical Trials Unit, which together form the Birmingham Centre for Clinical Trials – one of the largest clinical trials hubs in existence
    • Pioneers of innovative methodology in cancer trials

Artificial intelligence

• • • SPIRIT-AI and CONSORT-AI – world-first international standards for reporting of clinical trials which utilise AI and machine learning. Published in the BMJ, The Lancet and Nature Medicine
    • Systematically mapping under-representation within datasets used to build technologies – something we have termed ‘Health Data Poverty’.
    • In response, we have delivered the STANDING Together programme to improve the curation and reporting of datasets with regard to inclusion and data diversity to address this.

Advanced therapies

• • • Strong links with the co-located Precision Health Technologies Accelerator
    • Home to the Midlands-Wales Advanced Therapy Treatment Centre and the Oxford-Birmingham NIHR Blood and Transplant Research Unit in Precision and Cellular Therapeutic
    • Experienced in spinning-out new companies

Healthcare technology

• • • 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 businesses with design and development, validation, human factors engineering, usability studies and regulatory compliance, recently recognised and expanded through an NIHR HealthTech Research Centre award

March 2024: Medical Device Equity Review – Dr Xiaoxuan Liu and Professor Alastair Denniston supported the Review in relation to AI bias and ensuring equity of AI health technologies.

2023: WHO Report on Regulatory Considerations in Artificial Intelligence in Health – supported by Dr Xiaoxuan Liu

2023: Safe before Sale: Learnings from the FDA’s model of life sciences oversight for Foundation Models, Ada Lovelace Institute – supported by Dr Xiaoxuan Liu

November 2022: Regulatory Horizons Council report on regulation of AI as a Medical Device (AIaMD) – lead author Professor Alastair Denniston

2022: NICE Evidence Standards Frameworks for Digital Health Technologies including AI – academic leadership from Dr Xiaoxuan Liu and Professor Alastair Denniston

August 2021: CRSI was commissioned by the Regulatory Horizons Council (RHC), to produce four reports which have formed part of RHC’s ‘Report on Medical Devices Regulation’ calling for action from the government for regulatory reform of medical devices (all links open as PDFs):

• Report 1 – details a study examining lessons learned from COVID-19 in relation to regulations of in vitro diagnostics (IVDs – medical devices intended for use in diagnosis of disease or other conditions), and sets out the regulatory challenges such as the development of substandard diagnostic COVID-19 tests and lack of availability of reliable information during the pandemic. The report also sets out a series of recommendations on how the government could increase efficiency in test development and distribution in the event of a future infectious disease outbreak.
• Report 2 – details a study consulting on the mitigations for the move to the United Kingdom Conformity Assessed mark from July 2023, as a result of the end to the use of the EU CE mark for medical devices. The cost and complexity of complying with the new UK regulation to medical device companies means companies may prioritise non-UK markets, potentially reducing availability and choice of medical devices for UK healthcare.
• Report 3 – details a study looking at alternative routes to market for medical devices, probing the UK’s unique opportunity post-Brexit to update the way it regulates medical devices to promote patient outcomes, stimulate innovation, and ensure that the UK remains at the forefront of the global life sciences sector.
• Report 4 – summarises ideas and evidence around the opportunities and risks for future UK regulatory reform of medical devices in four key areas: patient and public access to high quality medical devices; international investment and innovation; patient and user safety; and global standing in regulation of the life sciences sector.

July 2020:  ‘Advancing Regulatory Science and Innovation in Healthcare’ – calls for a coherent and specific national strategy for regulatory science – including training, funding and cross-disciplinary working. 

Centre Director – Professor Alastair Denniston: A.Denniston@bham.ac.uk

Patient Reported Outcomes lead – Professor Melanie Calvert: m.calvert@bham.ac.uk

Artificial Intelligence in Healthcare Theme Lead – Dr Xiaoxuan Liu: x.liu.8@bham.ac.uk

Diagnostic Test Evaluation Theme Lead – Professor Jon Deeks: j.deeks@bham.ac.uk

Administrative Contact – Dr Eliot Marston: e.d.marston@bham.ac.uk