Clinical Therapeutics Research Centre Events
The Clinical Therapeutics Research Centre launched on 11 June 2019 with an inaugural lecture by Professor Sir Michael Rawlins GBE, MD, FRCP, FMedSci. Sir Michael is the Chair of MHRA, the national regulator of all medicines and medical devices used in the UK. The lecture followed two workshops that discussed the following questions:
- Are quality of life measures appropriate primary endpoints for pivotal (registration) clinical studies?
- Should tangible evidence of Patient and Public Involvement be mandatory for regulatory approval of Clinical Trial Applications (CTAs)?
St Hilda's Principal, Sir Gordon Duff, welcomed the full house and launched the new Research Centre. Professor Duncan Richards, Climax Professor of Clinical Therapeutics, introduced Sir Michael, who spoke on ‘Novel approaches to assessing the safety and efficacy of new medicines’. Sir Michael shared his thoughts on the field of clinical trials, how to integrate the patient’s voice into them, and the benefits of doing so. He considered traditional study designs, emerging study designs, alternative analytical approaches, and the use of biomarkers. Sir Michael concluded that approaches to trial designs and data analyses are changing. This could lead to the merging of experimental (deductive) and observational (inductive) techniques; a greater use of Bayesian methods, and the acceptance of biomarkers as a basis for marketing authorisation (licensing) under appropriate circumstances. The evening ended with a thought-provoking question and answer session.