04.01.12
Data ‘deliberately withheld’ in clinical trial reports
Incomplete clinical trial data can skew results and could lead to patient harm, bmj.com has warned today. A number of papers suggest that missing data can distort the scientific record and means that clinical decisions will not be based on the best evidence.
This research forms part of an in-depth review of clinical trial practice and found that a large proportion of evidence in clinical trials goes unreported. Furthermore, what is reported can be inadequate, researchers argue.
Studies have also shown that including unpublished data in reports on clinical trials can change their results. A report by Beth Hart states: “To ensure the accuracy and completeness of meta-analyses of the efficacy and safety of drugs, we urge the FDA and other drug regulatory authorities to make the full clinical study reports available to researchers.”
Dr Richard Lehman from the University of Oxford and BMJ Clinical Epidemiology Editor, Dr Elizabeth Loder, believe that concealment of data is “a serious ethical breach” and that clinical researchers who fail to disclose data “should be subject to disciplinary action by professional organisations”.
Lehman and Loder are also calling for more robust regulation for clinical trials and full access to raw trial data.
They conclude: “These changes have long been called for, and delay has already caused harm. The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.”
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