Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

Rockhold, Frank

doi:10.1093/annonc/mdx123

Cited by 5 publications

(8 citation statements)

References 28 publications

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“…This gap between the intention to share data and the lack of supportive regulatory and policy frameworks can be attributed to the direct or indirect effects connected with data sharing. At a macrolevel, this could be due to issues pertaining to IPR, differences across regulatory guidelines in high-income countries and LMICs, the variations in commercial interests of funding sources, and the potentially high economic benefits from data exclusivity [ 80 - 82 ]. Besides these issues, researchers are concerned about ensuring the privacy and confidentiality of study participants; although the informed consent procedures have provisions to seek participants’ consent for data sharing and secondary use of their data, these are rarely implemented in practice.…”

Section: Discussionmentioning

confidence: 99%

“…These could also hamper the efforts of clinical trial investigators seeking to incorporate specific data-sharing clauses in the informed consent procedures. Moreover, the cost associated with data sharing, potential threats to confidentiality, academic credit, and investigator capacity to standardize data in a shareable manner are some concerns from a researcher’s perspective [ 80 - 82 ]. Our gray literature screening of clinical trial websites showed that not every clinical trial agency is guided by its own data-sharing regulatory document ( Multimedia Appendix 2 ).…”

Section: Discussionmentioning

confidence: 99%

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Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Gudi¹,

Kamath²,

Chakraborty³

et al. 2022

J Med Internet Res

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Gudi¹,

Kamath²,

Chakraborty³

et al. 2022

J Med Internet Res

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“…To assess willingness to participate in health data networks, we asked whether participants were “comfortable having my electronic health information being a part of a network that includes” six different agencies or data networks: 1) other health care providers involved in my care, 2) all health care providers in my state, 3) social service agencies, 4) mental health services, 5) research networks, and 6) quality improvement networks. Participants rated their responses on a four-point “how true” scale ranging from “Not at all true [1]” to “Very true [4]”. We generated a measure of overall willingness to participate in multi-user data networks by summing the responses to questions about willingness to share data with each of the six potential participants in health data networks.…”

Section: Methodsmentioning

confidence: 99%

“…Networks that support health data and information exchange are at the heart of health IT infrastructure development and are a necessary element of learning health care systems [12], accelerated quality improvement, and more efficient implementation and patient care. The scope of networked data ranges from patient-level clinical trial and research data [34] to genetic data [5678] and electronic health record information [2, 91011]. Network-to-network connectivity and the capacity to exchange health information, including PHI, is maturing.…”

Section: Introductionmentioning

confidence: 99%

Willingness to Participate in Health Information Networks with Diverse Data Use: Evaluating Public Perspectives

Platt¹,

Raj²,

Büyüktür³

et al. 2019

eGEMs

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Introduction: Health information generated by health care encounters, research enterprises, and public health is increasingly interoperable and shareable across uses and users. This paper examines the US public’s willingness to be a part of multi-user health information networks and identifies factors associated with that willingness. Methods: Using a probability-based sample (n = 890), we examined the univariable and multivariable relationships between willingness to participate in health information networks and demographic factors, trust, altruism, beliefs about the public’s ethical obligation to participate in research, privacy, medical deception, and policy and governance using linear regression modeling. Results: Willingness to be a part of a multi-user network that includes health care providers, mental health, social services, research, or quality improvement is low (26 percent–7.4 percent, depending on the user). Using stepwise regression, we identified a model that explained 42.6 percent of the variability in willingness to participate and included nine statistically significant factors associated with the outcome: Trust in the health system, confidence in policy, the belief that people have an obligation to participate in research, the belief that health researchers are accountable for conducting ethical research, the desire to give permission, education, concerns about insurance, privacy, and preference for notification. Discussion: Our results suggest willingness to be a part of multi-user data networks is low, but that attention to governance may increase willingness. Building trust to enable acceptance of multi-use data networks will require a commitment to aligning data access practices with the expectations of the people whose data is being used.

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“…These have all been reviewed elsewhere. 27,28 The oncology community has also been quite active in the area of data sharing and several platforms have evolved specific to oncology. Oncology-focused data sharing has also been put center stage by former Vice President Joe Biden as part of his Cancer Moonshot program.…”

Section: Current Approaches To Open Data Accessmentioning

confidence: 99%

Open science: The open clinical trials data journey

Rockhold

Bromley²,

Wagner³

et al. 2019

Clinical Trials

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Open data sharing and access has the potential to promote transparency and reproducibility in research, contribute to education and training, and prompt innovative secondary research. Yet, there are many reasons why researchers don’t share their data. These include, among others, time and resource constraints, patient data privacy issues, lack of access to appropriate funding, insufficient recognition of the data originators’ contribution, and the concern that commercial or academic competitors may benefit from analyses based on shared data. Nevertheless, there is a positive interest within and across the research and patient communities to create shared data resources. In this perspective, we will try to highlight the spectrum of “openness” and “data access” that exists at present and highlight the strengths and weakness of current data access platforms, present current examples of data sharing platforms, and propose guidelines to revise current data sharing practices going forward.

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Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients

Cited by 5 publications

References 28 publications

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Regulatory Frameworks for Clinical Trial Data Sharing: Scoping Review

Willingness to Participate in Health Information Networks with Diverse Data Use: Evaluating Public Perspectives

Open science: The open clinical trials data journey

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