Time for a quality check before recruiting patients

doi:10.1136/bmj.39262.476921.3A

BMJ 2007;335:7 (7 July), doi:10.1136/bmj.39262.476921.3A

Letters

Drug trials in general practice

Time for a quality check before recruiting patients

The first 150 words of the full text of this article appear below.

In Norway, through our work in a general practice research committeeunder the Norwegian Medical Association, we have been involvedin a voluntary arrangement with pharmaceutical companies wherewe evaluate research projects initiated by the industry andrecruit general practitioners to find patients.¹ Our committeemakes recommendations to Norwegian general practitioners aboutwhether a project is a real research project rather than marketingcamouflaged as research.

However, after we criticised some projects in 2001, this arrangementhas been largely boycotted by the industry. One objection inone particular project was that the protocol favoured the company'sown drug. We also maintained that exaggerated demands for statisticalpower led to a grossly overestimated number of people participating.Research ethics should safeguard that type 2 error is prevented,but statistical power beyond reasonable limits (95% or greaterpower), leads to research where almost any difference reachessignificance. According to our view, this . . . [Full text of this article]

Knut A Holtedahl, professor¹, Eivind Meland, professor²

¹ Institute of Community Medicine, University of Tromsø, 9037 Tromsø, Norway, ² University of Bergen, Bergen, Norway

knutarne.holtedahl@ism.uit.no