Yale University. Open Data Access Project

Transcription

1 Open Data Access Project A Model for Dissemination and Independent Analysis of Clinical Trial Program Data Yale University

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5 What if. Yale University

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8 Merck concluded that the cardiovascular effects seen in the VIGOR trial were most likely explained by a cardiovascular effect of naproxen. Yale University

9 Month/ Year CV Event/Death RR (95% CI) P value 08/ ( ) 0.63 Yale University Source: Ross et al. Arch Intern Med 2009;169:

10 Month/ Year CV Event/Death RR (95% CI) P value 1.35 ( ) ( ) ( ) ( ) / ( ) 0.07 As of 12/00, same time as publication of VIGOR trial (Vioxx v. naproxen) where RR of MI was 5.00 ( ) Yale University Source: Ross et al. Arch Intern Med 2009;169:

11 Month/ Year CV Event/Death RR (95% CI) P value 1.35 ( ) ( ) ( ) ( ) ( ) / ( ) 0.05 As of 6/01, nearly 3 ½ years before Vioxx was withdrawn from market Yale University Source: Ross et al. Arch Intern Med 2009;169:

12 Month/ Year CV Event/Death RR (95% CI) P value 1.35 ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) 0.01 Yale University 11/ ( ) Source: Ross et al. Arch Intern Med 2009;169:

13 Not Just Vioxx Oseltamivir Reboxetine Rosiglitazone Yale University Source: BMJ 2010;341:c4737; NEJM 2007;356: ; BMJ 2010;341:c5641.

14 Source: Turner, et al. NEJM. 2008;358:

15 Source: Turner, et al. NEJM. 2008;358:

16 Source: Turner, et al. NEJM. 2008;358:

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25 46% of trials published! Yale University Source: Ross et al., PLoS Medicine 2009;6:e

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27 Trial Registration and Results Reporting 1997 FDA Modernization Act, section 113, provided public access to information about ongoing clinical trials in which they may be able to participate Led to creation of ClinicalTrials.gov 2007 FDA Amendments Act broadened scope Yale University

28 2007 FDA Amendments Act Expanded registry: all studies must be registered at inception Results database: trial results uploaded within 12 months of study completion (24 if under review) Basic results : baseline characteristics, 1 & 2 outcomes, statistical analyses (overall & by arm) Adverse events (serious & frequent) But, no access to trial data Yale University

29 Ryan MJ. Science. 2011;334:1229.

30 Peng RD. Science. 2011;334:1226.

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39 Bottom Line Substantial number of clinical trials are conducted, but never published Even among published trials, a limited portion of the collected data is reported Thus, patients and physicians frequently make treatment decisions with access to only a fraction of clinical research data Yale University

40 What can we do? Yale University

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45 YODA Project Model Designed to facilitate the release of data, ensure high quality reviews of the evidence, and provide the public with the scrutiny of independent review Yale University

46 Product Identified, including areas of concern Company releases to Coordinating Organization all clinical trial data (published/ unpublished); post-market surveillance data; and spontaneous adverse events Coordinating Organization oversight guidance Steering Committee YODA Development and Refinement of Approach for Disseminating Data Dissemination of Primary Data Review and Synthesis of Primary Data Project Model Conferences to discuss issues associated with promoting access to individual clinical product data: 1. Creating standardized protocol for permitting access to product clinical data 2. Issues in conducting systematic review and metaanalysis of product data, including clinical trial and postmarket surveillance data 3. Other issues: importance, strategies, gaps in statistical practice, practical concerns Development of Web site for project communications and facilitation of data distribution Communication of description of data files that will be made available to researchers Acceptance of requests for data using standardized protocol; review of proposals Processing of requests for data access; request and application posted on Web site Solicitation of proposals to conduct independent reviews Selection of 2 research groups data Review Organizations conduct independent evaluations in parallel Dissemination of conference proceedings via peer-reviewed journals and project Web site Dissemination of findings Distribution of data Requirement to submit results within 6 months of completion Yale University Dissemination of findings

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