Healthy Skepticism Library item: 10835

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Holtedahl KA, Meland E.
Drug trials in general practice
BMJ 2007 Jul 7; 335:(7609):7
http://www.bmj.com/cgi/content/full/335/7609/7-a

Abstract:

Time for a quality check before recruiting patients

In Norway, through our work in a general practice research committee under the Norwegian Medical Association, we have been involved in a voluntary arrangement with pharmaceutical companies where we evaluate research projects initiated by the industry and recruit general practitioners to find patients.1 Our committee makes recommendations to Norwegian general practitioners about whether a project is a real research project rather than marketing camouflaged as research.

However, after we criticised some projects in 2001, this arrangement has been largely boycotted by the industry. One objection in one particular project was that the protocol favoured the company’s own drug. We also maintained that exaggerated demands for statistical power 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 greater power), leads to research where almost any difference reaches significance. According to our view, this . . .