Clinical trials for medicinal products: Phase 1 Accreditation Scheme

Following the TGN1412 incident in March 2006, where six clinical trial subjects became seriously ill and were admitted to intensive care, an Expert Scientific Group (ESG) was formed to review Phase I clinical trials.  One of the recommendations from the ESG was to establish a national accreditation system for First in Human (FIH) studies. The MHRA have developed such a scheme in order to maximise subject safety and to create additional public confidence in the regulatory oversight of such trials. The development of the scheme has involved wide consultation with representatives from industry associations, academia, NHS, Department of Health, Ethics Committees, the Faculty of Pharmaceutical Medicine and the UK Resuscitation Council. In addition, the opinion of the Commission on Human Medicines (CHM) and also the Expert Advisory Group of the CHM has been sought. A public consultation exercise (MLX 341) took place which ended on 12 October 2007. The proposal has been revised to reflect these comments and we are now in a position to implement the scheme. We also plan to reconvene the consultative committee to review the scheme approximately six months following implementation.

The summary of responses to the public consultation and the final Phase I Accreditation Scheme document, along with the application form, for those units wishing to apply for accreditation are available below:

› Phase I Accreditation Scheme
› Phase I Accreditation Scheme - Application form (815Kb)
› Responses to public consultation of the Phase I Accreditation Scheme October 2007