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Table.  
Analytic Goal of Proposed Studies to Open Access Platform Review Panels With Representative Title Examplesa
Analytic Goal of Proposed Studies to Open Access Platform Review Panels With Representative Title Examplesa
1.
Krumholz  HM, Peterson  ED.  Open access to clinical trials data. JAMA. 2014;312(10):1002-1003.
PubMedArticle
2.
The YODA Project. The YODA Project website.http://yoda.yale.edu. Accessed January 26, 2016.
3.
ClinicalStudyDataRequest.com. ClinicalStudyDataRequest.com website. https://clinicalstudydatarequest.com/. Accessed January 26, 2016.
4.
Pencina  MJ, Louzao  DM, McCourt  BJ,  et al.  Supporting open access to clinical trial data for researchers: the Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. Am Heart J. 2016;172:64-69.
PubMedArticle
5.
Le Noury  J, Nardo  JM, Healy  D,  et al.  Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
PubMedArticle
Research Letter
March 22/29, 2016

Use of Open Access Platforms for Clinical Trial Data

Author Affiliations
  • 1Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
  • 2Associate Editor, JAMA
JAMA. 2016;315(12):1283-1284. doi:10.1001/jama.2016.2374

Concerns over bias in clinical trial reporting have stimulated calls for more open data sharing.1 In response, multiple pharmaceutical companies have created mechanisms for investigators to access patient-level clinical trials data. However, if and how these shared clinical trial data are being used is unknown.

Methods

We evaluated how many clinical trials were publicly available to investigators through 3 open access platforms: ClinicalStudyDataRequest.com, the Yale University Open Data Access Project (YODA), and the Supporting Open Access for Researchers (SOAR) initiative.24 Sponsors depositing data in these platforms include GlaxoSmithKline, Astellas, Boehringer Ingelheim, Eisai, Eli Lilly, Novartis, Roche, Sanofi, Takeda, Union Chimique Belge, ViiV Healthcare, Johnson & Johnson, Medtronic, and Bristol-Myers Squibb. Company policies on what trials are shared vary and are available online, but most include all trials within certain date ranges after regulatory review and publication of results.

Investigators submit a research proposal to the platforms, which is first reviewed for the availability of the trial(s) requested and completeness of the application. Next, the proposal is reviewed by a panel comprising independent experts or members of the platform. The panel then rejects or approves the proposal based on scientific merit and adequacy of the research design to achieve scientific objectives. A data sharing agreement is then created. Each platform requires investigators to report any resulting publications.

We reviewed all proposals with data use agreements since inception of each platform (first in 2013) and December 31, 2015 (obtained from ClinicalStudyDataRequest.com and the YODA website or directly from SOAR), the characteristics of accepted proposals, and reported publications. We classified the main objective of the analysis based on review of the analytic plan and study design.

Results

A total of 3255 clinical trials were available in the platforms, most of which were phase 3 (44.3% overall), followed by phase 1 (23.6%), phase 2 (18.3%), phase 4 (12.7%), and other (1.1%). Of the 234 proposals submitted, 177 had been processed and met initial requirements. The review panel rejected 12 of 177 proposals (6.8%), 10 were under review, and 4 had been withdrawn. Of the 154 proposals approved, data sharing agreements were completed for 113, including requests from 17 countries, most from the United States (n = 61; 54.0%). Most studies were not directly funded (n = 77; 68.1%).

The median number of trials requested by each proposal was 2 (range, 1-59; interquartile range, 1-6). Most proposals requested trials from a single sponsor; 29 proposals (8%) requested data from trials conducted by more than 1 sponsor. Only 505 unique trials (15.5% of available trials) had ever been requested, including 356 phase 3 trials (24.7% of phase 3 trials available). Analytic goals of these proposals varied, including secondary analyses of a trial’s treatment effect (n = 50; 44.3%) and analyses of the disease state itself (n = 31; 27.4%) (Table). Validation of the study primary end point was rare (n = 5; 4.4%). Only 1 proposal led to publication.5

Discussion

Although more than 3000 trials are available to investigators through open data platforms, only 15.5% had been requested by a limited number of researchers. Most proposals focused on nonprespecified subgroups or predictors of response rather than validation of study results.

Reasons for underutilization of clinical trials data may include lack of knowledge about these resources, possibly due to lack of publication of results from proposals, or lack of funding to support analyses. Incentive for validation studies may be limited as confirmatory reanalyses are less likely to be published. However, the 1 publication using these data was a validation study that found contradictory results from the initial article.5

This study has limitations. We focused on 3 platforms and were unable to obtain data from individual companies that share data. Details on rejected studies were unavailable. Certain information in proposals may be incomplete, such as funding or specific analytic plans. There may be a lag between publication of a report and posting on the platform website, and we did not independently search for publications.

Early use of platforms designed to provide access to individual patient data, developed to increase transparency of clinical trial data, has been limited. Availability of shared clinical trial data should be promoted and use of individual patient data for validation studies encouraged.

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Article Information
Section Editor: Jody W. Zylke, MD, Deputy Editor.

Correction: This article was corrected for errors in the conflict of interest disclosures on June 14, 2016.

Corresponding Author: Ann Marie Navar, MD, PhD, Duke Clinical Research Institute, Duke University Medical Center, 2400 Pratt St, Ste 7521, Durham, NC 27705 (navar006@dm.duke.edu).

Author Contributions: Dr Navar had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Navar, Peterson.

Acquisition, analysis, or interpretation of data: Navar, Pencina, Rymer, Louzao, Peterson.

Drafting of the manuscript: Navar, Pencina, Rymer, Louzao, Peterson.

Critical revision of the manuscript for important intellectual content: Navar, Pencina, Rymer, Louzao, Peterson.

Study supervision: Peterson.

Conflict of Interest Disclosures: Dr Navar reports receiving research funding from Sanofi and Regeneron. Dr Pencina reports that Duke University receives funding for the SOAR Initiative from Bristol-Myers Squibb. Dr Peterson reports receiving grant funding from the American College of Cardiology, American Heart Association, and Janssen; and consulting fees from Bayer, Boehringer Ingelheim, Merck, Valeant, Sanofi, Astra Zeneca, Janssen, Regeneron, and Genentech and that Duke University receives funding for the SOAR Initiative from Bristol-Myers Squibb. No other disclosures were reported.

Disclaimer: Dr Peterson, an associate editor for JAMA, was not involved in the editorial review of or the decision to publish this article.

References
1.
Krumholz  HM, Peterson  ED.  Open access to clinical trials data. JAMA. 2014;312(10):1002-1003.
PubMedArticle
2.
The YODA Project. The YODA Project website.http://yoda.yale.edu. Accessed January 26, 2016.
3.
ClinicalStudyDataRequest.com. ClinicalStudyDataRequest.com website. https://clinicalstudydatarequest.com/. Accessed January 26, 2016.
4.
Pencina  MJ, Louzao  DM, McCourt  BJ,  et al.  Supporting open access to clinical trial data for researchers: the Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. Am Heart J. 2016;172:64-69.
PubMedArticle
5.
Le Noury  J, Nardo  JM, Healy  D,  et al.  Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015;351:h4320.
PubMedArticle
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