Sponsors Struggle with Trial Disclosure, Patient Privacy Requirements


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-11-01-2019
Volume 28
Issue 11

Additional policies for registering clinical studies in U.S. and Europe aim to expand access to research data and provide timely information for patients on promising, new treatments.

Jill Wechsler

More comprehensive policies for regis­tering clinical studies in the U.S., Europe, and other regions aim to expand access to research data and to provide timely in­formation for patients on promising, new treatments. Wider sharing of clinical trial data and publication of study results is now considered central to ensuring maximum benefit from clinical research programs and for encouraging individuals to participate in the biomedical research enterprise. Such efforts, though, raise potential conflicts with broader privacy requirements, particularly in the European Union (EU) where policy­makers continue to widen rules designed to protect consumers from unauthorized disclosure of personal information.

The tension between data disclosure and individual privacy has gained attention as the EU readies full implementation of its General Data Protection Regulations (GDPR), which aims to provide individuals with more control over uses of personal data. Unfor­tunately, this policy designed to limit un­wanted individual exposure via electronic information systems appears at odds with efforts in many regions to promote data transparency policies designed to make bio­medical research results more available to healthcare entities and the research com­munity. Key issues are how regulators de­fine “personal data;” whether anonymiza­tion can permit flexibility in data use; which parties (sponsors, data processors, third-party researchers) may access data; and to what extent an individual may control uses of their personal data.

In addition, initiatives to establish plat­form studies that involve multiple sponsors and products, often using common controls, raise additional complexities for data track­ing, analysis, disclosure, and privacy protec­tion. And challenges arise from efforts by sponsors to protect confidential business information from release and to reduce the risk of individual re-identification.

Further complexity arises, moreover, as multiple regulatory authorities address these issues, noted research authorities at the Global Clinical Trial Disclosure & Data Transparency conference sponsored by DIA in September. Health Canada, for example, is implementing a revised process for public release of clinical information similar-but not the same-as EU Policy 0070, which requires disclosure of clinical trial results in the form of summary or aggregate data. Separately, the European Medicines Agency (EMA) and Health Canada now are releas­ing clinical study reports filed to support market applications for new drugs, a trans­parency issue controversial in the U.S. FDA policies and the Common Rule governing U.S.-funded and regulated biomedical re­search, however, require the registration of human subject research activities and publi­cation of summaries of study results.

Such efforts to expand access to re­search information raise concerns for how they will relate to the GDPR and other pri­vacy requirements. This will become more challenging if EU authorities further grant in­dividuals the right to remove personal data from documents and to withdraw consent. A serious threat is that such policies may hinder the transfer of personal data from the EU to U.S. entities, which could limit col­laboration between U.S. and EU sponsors and researchers.

Expanding disclosure

Meanwhile, the U.S. system for public reg­istration of clinical trials and disclosure of study results continues to expand. The Clini­calTrials.gov registration system operated by the National Library of Medicine over the past 20 years now lists 300,000 trials plus results from 38,000 studies. This has created “a really rich data resource,” with increased inclusion of full-study protocols, statistical analysis plans, and informed con­sent forms, commented ClinicalTrials.gov acting director Rebecca Williams at the DIA conference. The program is expected to become even more robust with efforts by the National Institutes of Health (NIH) to clarify requirements for the disclosure and dissemination of clinical trial information for all NIH-funded research.

To ensure that ClinicalTrials.gov contin­ues to provide a valuable resource, Williams is seeking more input from the public and from the full range of users to better un­derstand the needs of parties accessing clinical research information. One issue is whether sponsors should provide narrative or “plain language” summaries of studies that may be more useful for patients and other stakeholders.

The value and the risks of broader sharing of clinical data will be further explored at a public workshop this month sponsored by the National Academies of Sciences, Engi­neering, and Medicine (NASEM). Experts will examine advances in this area and continu­ing challenges since publication in 2015 of an Institute of Medicine report on Sharing Clinical Trial Data. A previous meeting in September discussed how more consistent and clearer reporting policies and guidelines could help increase transparency in biomed­ical research by researchers, institutions, funders, and medical journals.

The November 18-19 session plans to take a broad look at the successes and fail­ures in data sharing and reuse by public and private researchers, as well as perspectives of trial participants, patient organizations, and sponsors. One aim is to reach agree­ment on ways to better harmonize poli­cies, standards, and incentives to overcome barriers and increase the value of clinical research.

Jill Wechsler is the Washington Correspondent for Applied Clinical Trials.


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