pdf: The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience

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Doshi P, Jefferson T, Del Mar C (2012)

The Imperative to Share Clinical Study Reports: Recommendations

from the Tamiflu Experience.

PLoS Med 9(4): e1001201.

http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001201

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.

see also:

Roche's Tamiflu scandal questions the entire process of systematic

review <http://www.theoneclickgroup.co.uk/news.php?id=6812#newspost>

, medpage TODAY