Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Abstract

Background Although well recognized for its scientific value, data sharing from clinical trials remains limited. Steps toward harmonization and standardization are increasing in various pockets of the global scientific community. This issue has gained salience during the COVID-19 pandemic. Even for agencies willing to share data, data exclusivity practices complicate matters; strict regulations by funders affect this even further. Finally, many low- and middle-income countries (LMICs) have weaker institutional mechanisms. This complex of factors hampers research and rapid response during public health emergencies. This drew our attention to the need for a review of the regulatory landscape governing clinical trial data sharing. Objective This review seeks to identify regulatory frameworks and policies that govern clinical trial data sharing and explore key elements of data-sharing mechanisms as outlined in existing regulatory documents. Following from, and based on, this empirical analysis of gaps in existing policy frameworks, we aimed to suggest focal areas for policy interventions on a systematic basis to facilitate clinical trial data sharing. Methods We followed the JBI scoping review approach. Our review covered electronic databases and relevant gray literature through a targeted web search. We included records (all publication types, except for conference abstracts) available in English that describe clinical trial data–sharing policies, guidelines, or standard operating procedures. Data extraction was performed independently by 2 authors, and findings were summarized using a narrative synthesis approach. Results We identified 4 articles and 13 policy documents; none originated from LMICs. Most (11/17, 65%) of the clinical trial agencies mandated a data-sharing agreement; 47% (8/17) of these policies required informed consent by trial participants; and 71% (12/17) outlined requirements for a data-sharing proposal review committee. Data-sharing policies have, a priori, milestone-based timelines when clinical trial data can be shared. We classify clinical trial agencies as following either controlled- or open-access data-sharing models. Incentives to promote data sharing and distinctions between mandated requirements and supportive requirements for informed consent during the data-sharing process remain gray areas, needing explication. To augment participant privacy and confidentiality, a neutral institutional mechanism to oversee dissemination of information from the appropriate data sets and more policy interventions led by LMICs to facilitate data sharing are strongly recommended. Conclusions Our review outlines the immediate need for developing a pragmatic data-sharing mechanism that aims to improve research and innovations as well as facilitate cross-border collaborations. Although a one-policy-fits-all approach would not account for regional and subnational legislation, we suggest that a focus on key elements of data-sharing mechanisms can be used to inform the development of flexible yet comprehensive data-sharing policies so that institutional mechanisms rather than disparate efforts guide data generation, which is the foundation of all scientific endeavor.

Structural under-reporting of informed consent, data handling and sharing, ethical approval, and application of Open Science principles as proxies for study quality conduct in COVID-19 research: a systematic scoping review

“…However, sharing data too rapidly, for example, relying on data analysed and reported without peer review on preprint servers, might spread misinformation 24. Nevertheless, data sharing needs to happen according to specific rules and regulations, such as GDPR in Europe and HIPAA in the USA 16 22 23 27. Data transfer or sharing agreements form a legal basis for sharing data for a predefined purpose 60.…”

“…Moreover, facets of informed consent and responsible data use are potentially compromised during a more urgent need for clinical answers, as was the case during the COVID-19 pandemic 18 24 26. Informed consent procedures and adherence to data-sharing principles are nevertheless a prerequisite to assure high-quality and responsible conduct of clinical studies, especially in challenging eras such as the COVID-19 pandemic 27. Although there have been publications in the past that evaluated aspects such as informed consent reporting and reporting of review board approval,27–30 it is currently unknown how these aspects were handled during the pandemic.…”

Rapid review on monkeypox policies among the G20 nations: relevance to policy and practitioner

“… 14 Since the research question is broad, we did not follow the typical PICOS or the PCC framework and the approach has been demonstrated previously. 15 , 16 We could not register the rapid review protocol as the review was completed in six days timeframe. We have reported this review based on the “Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews”.…”

Open video data sharing in developmental science and clinical practice

“…Data sharing, however, faces a thicket of thorny issues, which have triggered contentious discourses by researchers, leading academic journals, funders and international organizations in the past years. 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 Although researchers are increasingly expected by funders, the scientific community, and tax payers to share data, 6 , 13 a lack of actual incentives for primary researchers, aggravated by the extra operational costs and efforts necessary to curate data, impede such practice. 14 , 15 , 16 Especially, when working with video data with identifiable individuals, ensuring the protection of participants’ confidentiality is critical.…”