Time to treat as independentBMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c6837 (Published 30 November 2010) Cite this as: BMJ 2010;341:c6837
- Tom MacDonald, professor of clinical pharmacology1,
- Chris Hawkey, professor of gastroenterology2,
- Ian Ford, professor of biostatistics3
- 1Medicines Monitoring Unit, Division of Medical Sciences, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK
- 2University Hospital Nottingham, Wolfson Digestive Diseases Centre, Nottingham NG7 2UH, UK
- 3Robertson Centre for Biostatistics, University of Glasgow, Glasgow G12 8QQ, UK
In response to the rosiglitazone affair, Steinbrook and Kassirer suggest that more trials should be sponsored, funded, and conducted by organisations independent of industry.1 We agree. We operate close to that model with two studies requested by the European Medicines Agency. Academics wrote the protocols, collaborators are academic, and the study data are owned by the steering committees (on which industry has no say), which also control analyses and publications. A university is the sponsor. Funding is from industry, which has no role in study conduct, data collection, or data interpretation.
So is everything rosy? Unfortunately not.
In the UK many primary care practices regard these studies as commercial and will not participate. The Danish Board of Medicines also classifies them as “commercial” and requires participating practices to register this interest, which results in practices withdrawing from the studies. This threatens the viability of doing studies in Denmark to the detriment of everyone.
We have sought to do research at “arm’s length” from industry. Applied widely, our model would obviate many of the problems with industry sponsored research. This would be in the public interest.
Our concern is that academic sponsorship is not treated as “independent” but seen as commercial. The Danish Medicines Board’s decision will have no good outcome. It is retrogressive and against the public interest.
We hope that others view academic ownership and sponsorship more positively. There will be no hiding of results by us.
Cite this as: BMJ 2010;341:c6837
Competing interests: The three authors form the executive of a trial originally requested by the European Medicines Agency that is funded by Pfizer.