Dr Martin O’Kane
Clinical Trials Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Dr Kirsty Wydenbach
Expert Medical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
The UK stands at an inflection point to accelerate change and strengthen our clinical research capability.
In March 2021, the Government set out its vision to create a more efficient, patient-centred, pro-innovation and digitally enabled clinical research environment. The MHRA, working with partners across the UK research ecosystem, is actively supporting this vision, which is centred around five overarching themes:
- Clinical research embedded in the NHS
- Patient-centred research
- Streamlined, efficient and innovative research
- Research enabled by data and digital tools
- A sustainable and supported research workforce
Efficient design, approval and delivery of research
Through our scientific advice and outreach activities, we have facilitated approval of trials with innovative protocol designs, resulting in a doubling of these trials from 19 in 2019 to 42 in 2020 (14 of which were COVID-19 trials).
As well as supporting innovative designs, we have been streamlining the approvals process with colleagues from the UK research ethics services by developing a single application for joint regulatory and ethics review, reportedly reducing trial set up times by 30%. The MHRA Clinical Practice Research Datalink (CPRD) is also facilitating efficient delivery of trials via an innovative service to efficiently locate patients across the UK who are potentially eligible for a clinical trial and hence accelerate recruitment.
Patient involvement needs to be at the heart of drug development and clinical trials.
Incorporating the patient voice and improving diversity
Patient involvement needs to be at the heart of drug development and clinical trials, we recently launched a programme to ensure that pharmaceutical companies and research teams incorporate the immense value of the patient voice. Support for decentralised methods of trial conduct will enable delivery of trials where the patients with the greatest need are located by helping to “bring the trial to the patient.”
We are documenting where there is evidence of patient involvement in clinical trial applications. When licensing submissions for new active substances and new indications are received, the applicant company will be expected to show evidence of the ways in which patients were engaged in the drug’s development and the impact this has had.