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

Doshi, Peter; Jefferson, Tom; Mar, Chris Del

doi:10.1371/journal.pmed.1001201

Cited by 145 publications

(121 citation statements)

References 30 publications

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“…Our results demonstrate that such efforts could reduce opportunities for cherrypicking. When used systematically, our findings support the theory that nonpublic sources may improve the accuracy and quality of evidence syntheses [56]. However, our results also suggest that nonpublic data could increase burden on reviewers and introduce new opportunities for cherry-picking.…”

Section: Discussionsupporting

confidence: 78%

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

Mayo‐Wilson

Fusco

et al. 2017

Journal of Clinical Epidemiology

109

163

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Objective: To identify variations in outcomes and results across reports of randomized clinical trials (RCTs). Study Design and Setting: Eligible RCTs examined gabapentin for neuropathic pain and quetiapine for bipolar depression, reported in public (e.g., journal articles) and nonpublic (e.g., clinical study reports) sources by 2015. We prespecified outcome domains. From each source, we collected ''outcomes'' (i.e., domain, measure, metric, method of aggregation, and time point); ''treatment effect'' (i.e., outcome plus the methods of analysis [e.g., how missing data were handled]); and results (i.e., numerical contrasts of treatment and comparison groups). We assessed whether results included sufficient information for meta-analysis.Results: We found 21 gabapentin (68 public, 6 nonpublic reports) and seven quetiapine RCTs (46 public, 4 nonpublic reports). For four (gabapentin) and seven (quetiapine) prespecified outcome domains, RCTs reported 214 and 81 outcomes by varying four elements. RCTs assessed 605 and 188 treatment effects by varying the analysis of those outcomes. RCTs reported 1,230 and 661 meta-analyzable results, 305 (25%) and 109 (16%) in public reports.Conclusion: RCTs included hundreds of outcomes and results; a small proportion were in public reports. Trialists and meta-analysts may cherry-pick what they report from multiple sources of RCT information. Ó 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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Section: Discussionsupporting

confidence: 78%

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

Mayo‐Wilson

Fusco

et al. 2017

Journal of Clinical Epidemiology

109

163

View full text Add to dashboard Cite

show abstract

“…30 Enhance transparency in Health Canada's decision-making A related issue is the transparency of Health Canada's own decision-making. At present, Health Canada publishes limited information solely on a subset of its decisions, specifically, on drugs approved for sale and high-risk medical devices.…”

Section: E290mentioning

confidence: 99%

Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Herder

Gibson

Graham

et al. 2014

CMAJ

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“…However, I suspect that post-publication review and commenting may become largely an exchange of opinions and biases, unless it is supplanted with access to raw data, protocols, and analyses codes. Such access would allow postpublication reviewers and replicators to make more meaningful contributions to scientific reproducibility and clinical implementation [4,5].…”

mentioning

confidence: 99%

Research accomplishments that are too good to be true: reply to Ting

Ioannidis

2014

Intensive Care Med

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

Abstract: 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.

Cited by 145 publications

References 30 publications

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?

Research accomplishments that are too good to be true: reply to Ting

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