MHRA phase I accreditation scheme from the perspective of an ex-Lead Inspector

抄録

A regulatory perspective of MHRA Phase 1 accreditation scheme: While a harmful incident did occur, in the UK in March 2006, we will look briefly at what one of the recommendations from the Expert Scientific Group on Phase I Clinical Trials; The Voluntary Accreditation Scheme. Looking back: how did regulators and the industry align on the additional voluntary regulations beyond the current GCP requirement and the direction from the conceptual stage? Were there any objections from the industry side to imposing particularly from the perspective of promoting the development of new drugs? How did patient and patient groups perceive the scheme? Impact of the scheme: While the scheme emphasizes safety, could it hinder access to new treatment options? How does the scheme impact patients versus healthy volunteer trials or single versus multiple investigator sites? The co-existence of accredited and non-accredited units, what are the considerations for sponsor and the units themselves?