The imperative to share clinical study reports: Recommendations from the Tamiflu experience

Peter Doshi, Tom Jefferson, Chris del Mar

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Abstract

Summary Points
Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.
Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers.
We propose clinical study reports become available to such scrutiny, and describe one manufacturer's unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.
Original languageEnglish
Article numbere1001201
JournalPLoS Medicine
Volume9
Issue number4
DOIs
Publication statusPublished - Apr 2012

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Oseltamivir
Industry
Randomized Controlled Trials
Confidentiality
Research Personnel
Clinical Studies
Clinical Trials
Pharmaceutical Preparations

Cite this

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The imperative to share clinical study reports : Recommendations from the Tamiflu experience. / Doshi, Peter; Jefferson, Tom; del Mar, Chris.

In: PLoS Medicine, Vol. 9, No. 4, e1001201, 04.2012.

Research output: Contribution to journalArticleResearchpeer-review

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