Deficiencies in proposed new EU regulation of clinical trials

BMJ 2012; 345 doi: (Published 20 December 2012) Cite this as: BMJ 2012;345:e8522

Re: Deficiencies in proposed new EU regulation of clinical trials

I thank P C Goetzsche very much for his carefull analysis of the new EU regulation of clinical trials. He missed however that there are serious deficiencies from an ethical and trial participant's point of view too.

The proposal of the EU Commission is fundamentally different from the requirements of the present EU Directive 2001/20/EC: a comprehensive and independent consideration and vote by a multidisciplinary, independent Ethics Committee is no longer required. This violates international guidelines and ethical codes, such as the Declaration of Helsinki of the World Medical Association, the Bioethics Convention of the Council of Europe and the WHO International Guidelines. These internationally recognized principles require the approval of an independent Ethics Committee, including an examination of whether the protection of the rights, welfare and safety, as well as self-determination of potential study participants is guaranteed. By eliminating the mandatory requirement of an independent review by the national competent Ethics Committee, this protection can no longer be sustained.

Driven essentially by competitive motives, Brussels is aiming to establish a centralized approval process for clinical trials with extremely shortened time-lines, as a European location advantage. The already existing short lead times from 30 to 60 calendar days are to be drastically reduced even further. For certain processes laid down in the proposal, requiring national and often also international coordination, deadlines of 3,4, 6, 10 and 25 calendar days are set. Time limits like these do not allow for an appropriate assessment of complex clinical trials and their associated risks and must be considered as irresponsible in neglecting the welfare and protection of clinical trial participants.Against the background that planning, execution and evaluation of multinational studies often extends over several years, is also incomprehensible that by shortening the already existing tight timescales, any significant location advantages are to be achieved.
The planned changes restrict patient protection and undermine public confidence in drug trials. Thus there is an urgent need to modify the EU proposal in a way that it complies with the current version of the Declaration of Helsinki

Competing interests: I am the president of the Permanent Working Party of Research Ethics Committees in Germany and lead participant in the European LeukemiaNet

23 December 2012
Joerg Hasford
Medical Statistician, Physician
Arbeitskreis Medizinischer Ethik-Kommissionen in Deutschland e.V.
Scharnitzerstr.7 D-82166 Graefelfing, Germany