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5 Access to Clinical Trial Data: Governance
Pages 139-162

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From page 139...
... The term "open access" was first applied to allowing any member of the public with Internet access to read and download for free the full text of articles from scientific journals for unrestricted use. In the context of clinical trial data, "open access" implies unrestricted and free access to data (Krumholz and Peterson, 2014)
From page 140...
... experience with sharing clinical trial data, lawyers, other companies, and consultants were the most common data requestors (Rabesandratana, 2013)
From page 141...
... is appropriate and desirable for sharing clinical trial results and that in some cases, no or few controls on sharing other types of clinical trial data may be the preferred approach when all stakeholders involved in a clinical trial (i.e., sponsors, investigators, and participants) are comfortable with this approach and believe the benefits outweigh the risks.
From page 142...
... Approaches to MitigatING the risks of Data Sharing Various approaches to mitigating the risks of sharing clinical trial data are currently being implemented according to the interests, concerns, and BOX 5-2 Use of Shared Data for Another Company's Regulatory Submission Sponsors of clinical trials have serious concerns about competitors copying data packages that lack strong regulatory data protection. If competitors can ob tain regulatory approval primarily on the basis of shared data and not their own work, companies and their investors may be reluctant to assume the high costs and risks of developing new therapies and carrying out the clinical trials required for regulatory approval.
From page 143...
... That being said, to the extent that data set providers use a common website, some aggregation may be possible. For example, although the website for sharing clinical trial data that Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Novartis, Roche, Sanofi, and ViiV Healthcare have agreed to use (www.ClinicalStudyDataRequest.com)
From page 144...
... Consequently, the committee does not recommend one access model for all trials and types of clinical trial data but instead presents the rationale for using various controls on access to clinical trial data and recommends operational strategies for their use. Current practices for mitigating the risks of data sharing include the de-identification of data; making data available for inspection and analysis but not for downloading; registration and the use of data use agreements (DUAs)
From page 145...
... Li, Multi-Regional Clinical Trials (MRCT) Center, to A
From page 146...
... . Successful re-identification attacks on properly de-identified or anonymized health or clinical data are rare, but they happen.6,7 Reducing ­ the risk of re-identification of data subjects is a valuable tool for ensuring that the benefits of data sharing outweigh the risks, but it should not be the 5  Ibid.
From page 147...
... Making Data Available for Use But Not Downloadable Several data sharing programs are granting some access to clinical trial data to secondary users but not allowing them to download the data to their own computers. The EMA is allowing users to view data online after simple registration; to download data, secondary users must agree to additional conditions.
From page 148...
... The committee does not endorse all the above provisions in DUAs but believes that sponsors, funders, and intermediaries that hold and release clinical trial data should consider these provisions as potential options for increasing the benefits and reducing the risks of sharing clinical trial data. From a legal perspective, it is not clear whether and how these DUAs can be enforced if violated by secondary users, and the committee could not find any relevant case law.
From page 149...
... . Proponents contend that review of data requests helps protect against invalid secondary uses of the data, which may occur for a number of reasons, including unfamiliarity with the data set and its limitations, invalid statistical methods, the BOX 5-4 ClinicalStudyDataRequest.com ClinicalStudyDataRequest.com is a multisponsor Web system, launched in January 2014 for requesting clinical trial data, which is based on a system initially launched in May 2013 by GlaxoSmithKline (GSK)
From page 150...
... Brown and G Fleming, to Committee on Strategies for Responsible Sharing of Clinical Trial Data, Institute of Medicine, regarding clinical trial data sharing: product liability, April 9, 2014.
From page 151...
... Fleming, to Committee on Strategies for Responsible Sharing of Clinical Trial Data, Institute of Medicine, regarding clinical trial data sharing: product liability, April 9, 2014.
From page 152...
... Controlling Access Based on Data Access Requests Several models for sharing clinical trial data entail reviewing the scientific rationale or purpose of data requests and the ability of the proposed research and data analysis plan to achieve the scientific objectives. The rationale for such review is to screen out data requests that lack a valid purpose or research or data analysis plan and therefore will not produce valid scientific knowledge that benefits the public.
From page 153...
... Conclusion: Controlling access on the basis of the purpose and/or scientific validity of the research proposal may be an effective strategy for mitigating risk, although overly restrictive controls are undesirable because they would inhibit valid secondary analyses and innovative scientific proposals. Independent Review Panels Use of review panels to control access to clinical trial data by reviewing and approving data requests raises important questions regarding implementation: Who decides whether data requestors gain access to the
From page 154...
... . Several large drug manufacturers have established programs for sharing clinical trial data using an independent review panel to determine access to the data.
From page 155...
... Currently, many review panels established by pharmaceutical companies do not include representation of clinical trial participants, their communities, disease advocacy groups, or the public. But as discussed in Chapter 3, engaging these stakeholders and giving them a meaningful voice can help sponsors and investigators better understand their concerns and can suggest constructive ways of addressing those concerns and improving the sharing of clinical trial data generally.
From page 156...
... Conclusion: It is best practice that policy and procedures regarding access to clinical trial data be transparent, including •  ublic reporting of the policies and procedures for sharing clinical p trial data (including criteria for determining access and conditions of use) , as well as the names of individuals making decisions about access and serving on the governing body of the unit determining access; and •  ublic reporting of a summary of the disposition of data sharing p requests, including the number of requests and approvals and the reasons for disapprovals.
From page 157...
... Finally, new issues and challenges are likely to emerge as more experience is gained with data sharing. recommendation The committee drew together the deliberations detailed in this chapter with the following overarching recommendation: Recommendation 3: Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive clinical trial data by implementing operational strategies that include employ ing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent.
From page 158...
... • Learn from experience by collecting data on the outcomes of data sharing policies, procedures, and technical approaches (including the benefits, risks, and costs) , and share information and lessons learned with clinical trial sponsors, the public, and other organiza tions sharing clinical trial data.
From page 159...
... 2014. Open letter: European Medicines Agency should remove barriers to access clinical trial data.
From page 160...
... 2013. Principles for respon sible clinical trial data sharing: Our commitment to patients and researchers.
From page 161...
... Project policy for the public availability of RHBMP-2 clinical trial data. New Haven, CT: Yale University Center for Outcomes Research and Evaluation.


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