Squeezing academic research into a commercial straitjacketBMJ 2004; 328 doi: https://doi.org/10.1136/bmj.328.7447.1036 (Published 29 April 2004) Cite this as: BMJ 2004;328:1036
- Susan Mayor
New EU regulations for clinical trials come into effect this week. Susan Mayor talks to academics about the danger they pose to research
A new European directive on clinical trials that takes effect this week may seriously damage academic medical research by applying a “one size fits all” approach to the organisation of clinical trials that is more suited to trials designed for the registration of new drugs by pharmaceutical companies.
The aim of the European Union Clinical Trials Directive (2001/20/EC) was to harmonise the approval and monitoring of clinical research in different countries in Europe and to set pan-European standards of protection for all participants in clinical trials. It requires that all trials have a single sponsor, who carries full responsibility and liability, including covering the costs of all drugs or devices used in a study. This concept is familiar to commercial clinical research, where a pharmaceutical company is generally the sole sponsor of a trial. However, publicly funded research studies have previously generally operated as collaborations in which partners oversee different aspects of a trial.
Rory Collins, British Heart Foundation professor of medicine and epidemiology at the University of Oxford, explained the problem: “Many non-commercial research funders, universities, and hospitals are unlikely to accept formal responsibility in the new ‘corporate sponsor model’ because …