Healthy Skepticism Library item: 18865

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

Freemantle N
Commentary: journals must facilitate the dissemination and scrutiny of clinical research
BMJ 2010 Oct 12; 341:
http://www.bmj.com/content/341/bmj.c5397.extract

Abstract:

Steinbrook and Kassirer’s analysis article (doi:10.1136/bmj.c5391)-which suggests that medical journals should require full access to data for industry sponsored trials-broaches many questions, but it is not clear that it advances our thinking. The first question raised is whether the authors truly comprehend the nature of large scale randomised trials. Trials are a major industry; complex, costly, and bureaucratic. Good chairs of steering committees do check carefully that things are done properly, at least to the extent that they are able, but such scrutiny is fundamentally, in the context of drug development and safety, the responsibility of the regulators.

The RECORD trial1 suffered from a number of methodological challenges, in particular unacceptably high levels of loss to follow-up.2 It is not surprising that some of the judgments of a blinded endpoints committee were contestable. The reason we have such committees is because a simple algorithm …