Sunday, February 03, 2013

Missing trial data – briefing notes.

Doctors need the results of clinical trials to make decisions about which treatment is best.

Currently, drug companies and researchers are allowed to withhold the results of clinical trials from doctors and patients if they wish to, alongside other information. This means that we are misled about the benefits and risks of treatments. We can be misled into prescribing an expensive new drug, for example, when in reality an older cheaper one is more effective. Patients are harmed and money is wasted.

This problem is very well documented, and widely discussed within the profession. Legislators have failed to engage on the issue.

The current best estimate is that half of all the clinical trials that have been conducted and completed have never been published in academic journals, and trials with positive results are twice as likely to be published as others. This figure comes from a systematic review conducted in 2010 by the NHS NIHR Health Technology Assessment programme.

This problem occurs for industry and non-industry trials, internationally, at all stages of drug development, and for trials of all sizes.

Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. Sim I, editor. PLoS Medicine. 2009 Sep 8;6:e1000144. 00144

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