Healthy Skepticism Library item: 19769

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

Lehman R, Loder E
Missing clinical trial data
BMJ 2012 Jan 3; 344:
http://www.bmj.com/content/344/bmj.d8158

Abstract:

A threat to the integrity of evidence based medicine

Clinical medicine involves making decisions under uncertainty. Clinical research aims to reduce this uncertainty, usually by performing experiments on groups of people who consent to run the risks of such trials in the belief that the resulting knowledge will benefit others. Most clinicians assume that the complex regulatory systems that govern human research ensure that this knowledge is relevant, reliable, and properly disseminated. It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.

The linked cluster of papers on unpublished evidence should reinforce this sense of shock. These articles confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis—we are talking simply about the absence of the data. And this is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems. Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants.

The linked articles look closely at the extent, causes, and consequences of unpublished evidence from clinical trials. Hart and colleagues incorporated unpublished evidence into existing meta-analyses of nine drugs approved by the US Food and Drug Administration in 2001 and 2002.1 These …