Giuseppe
Emeritus
[Source: PLoS Medicine, full text: (LINK). Summary, edited.]
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The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy.
Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy.
Peter Doshi<SUP>1</SUP><SUP>*</SUP>, Tom Jefferson<SUP>2</SUP>, Chris Del Mar<SUP>3</SUP>
<SUP></SUP>
1 Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America, 2 The Cochrane Collaboration, Roma, Italy, 3 Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, Australia
Citation: 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. doi:10.1371/journal.pmed.1001201
Published: April 10, 2012
Copyright: ? 2012 Doshi et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: Peter Doshi is funded by an institutional training grant from the Agency for Healthcare Research and Quality #T32HS019488. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: All review authors have applied for and received competitive research grants. All review authors are co-recipients of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (http://www.hta.ac.uk/2352 ). In addition: TJ was an ad hoc consultant for F. Hoffman-La Roche Ltd in 1998?1999. TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, none of which are on neuraminidase inhibitors. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 products unrelated to neuraminidase inhibitors. Since submission of this article, TJ has been retained as an expert consultant in a legal case involving Tamiflu. CDM provided expert advice to GlaxoSmithKline about vaccination against acute otitis media in 2008?2009. CDM receives royalties from books published through Blackwells BMJ Books and Elsevier. PD declares no further conflicts of interest.
Abbreviations: ACIP, Advisory Committee on Immunization Practices; CDC, US Centers for Disease Control and Prevention; EMA, European Medicines Agency; FDA, US Food and Drug Administration; HHS, US Department of Health and Human Services; WHO, World Health Organization
* E-mail: pnd@jhu.edu
Provenance: Not commissioned; externally peer reviewed.
Summary Points
-<SUP></SUP>
1 Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America, 2 The Cochrane Collaboration, Roma, Italy, 3 Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, Australia
Citation: 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. doi:10.1371/journal.pmed.1001201
Published: April 10, 2012
Copyright: ? 2012 Doshi et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: Peter Doshi is funded by an institutional training grant from the Agency for Healthcare Research and Quality #T32HS019488. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: All review authors have applied for and received competitive research grants. All review authors are co-recipients of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (http://www.hta.ac.uk/2352 ). In addition: TJ was an ad hoc consultant for F. Hoffman-La Roche Ltd in 1998?1999. TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, none of which are on neuraminidase inhibitors. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 products unrelated to neuraminidase inhibitors. Since submission of this article, TJ has been retained as an expert consultant in a legal case involving Tamiflu. CDM provided expert advice to GlaxoSmithKline about vaccination against acute otitis media in 2008?2009. CDM receives royalties from books published through Blackwells BMJ Books and Elsevier. PD declares no further conflicts of interest.
Abbreviations: ACIP, Advisory Committee on Immunization Practices; CDC, US Centers for Disease Control and Prevention; EMA, European Medicines Agency; FDA, US Food and Drug Administration; HHS, US Department of Health and Human Services; WHO, World Health Organization
* E-mail: pnd@jhu.edu
Provenance: Not commissioned; externally peer reviewed.
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.
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