The upcoming debate on the proposal for European regulation on clinical trials will have to unravel many knots. In addition to removing any reference to Ethics Committees, the proposal, released by the EU Commission, established ground for a single scientific assessment for the authorisation to conduct a clinical trial. This one-entry evaluation, which will then be valid for all concerned member states, has been artificially dissociated from national ethical assessments (1). Other deregulation measures were also put forward, introducing provisions that will negatively impact on the protection of trial participants, such as narrowing the definition of a clinical trial. This change would allow some post-authorisation trials to fall outside the scope of the new regulation or to be labelled as low-intervention clinical trials, thus exempting sponsors from having to provide any compensation for damages incurred by trials participants.

Many interested parties have expressed their dissent with the EU Commission’s proposal (2,3). The draft report by Glenis Willmott (Member of the European Parliament) is heading in the right direction, having partly responded to some of the ethical and transparency concerns (4).

Yet, the revision of the Clinical Trials Regulation offers a major opportunity to redirect clinical research and development towards a model that meets real public health needs, by:

1. requiring comparative clinical trials in accordance with the Declaration of Helsinki which specifies that "The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention", and warns against the use of placebo-controlled clinical trials, stating that "extreme care must be taken to avoid abuse of this option";
    
2. granting public access to raw data and clinical study reports, which would allow independent analysis and early detection of safety problems;
    
3. discouraging the conduct of unethical trials in countries outside the EU by demanding that clinical data submitted in the Common Technical Document (when applying for a medicine's marketing authorisation) is obtained from registered clinical trials that duly comply with the provisions of the new regulation; and
    
4. enacting and enforcing effective monitoring of clinical trials, to prevent any omission and data withholding.
    

I declare that I have no conflicts of interest.

Bruno Toussaint
contact@prescrire.org
Prescrire, 75558 Paris Cedex 11, FRANCE

> Read this response online at thelancet.com

©Prescrire 1 July 2013

Source: www.thelancet.com Vol 381 May 18, 2013 p 1719-1720

References:
1 - European Commission. Proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Brussels: European Commission, 2012.
2 - AIM, ISDB, MiEF, WEMOS. Proposed regulation on clinical trials: joint analysis. http://english.prescrire.org/en/79/207/46302/2507/2506/SubReportDetails.aspx (accessed April 24, 2013). > Click here
3 - Gøtzche PC. Deficiencies in proposed new EU regulation of clinical trials. BMJ 2012; 345: e8522.
4 - Willmott G. Draft Report on the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. http://www.europarl.europa.eu/ sides/getDoc.do?pubRef=-//EP//NONSGML% 2BCOMPARL%2BPE-504.236% 2B01% 2BDOC% 2BPDF%2BV0//EN (accessed April 24, 2013).