Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop

Responsible sharing of clinical trial data is widely recognized as serving the public interest. Data sharing helps maximize the contributions to scientific knowledge made by clinical trial participants – benefiting patients today and in the future. Clinical trial data sharing can enable reproducibility of research findings, analyses for other areas of study; and exploratory work to generate new research hypotheses. While progress has been made in the endeavor of improving clinical trial data sharing, challenges still remain.

On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop, in Washington, DC, titled “Sharing Clinical Trial Data: Challenges and a Way Forward.” The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse since the report release. The workshop considered ways in which policy, technology, incentives, and governance could be leveraged to overcome remaining barriers and further facilitate data sharing.

Co-sponsored by the Wellcome Trust, the workshop was jointly convened by the National Academies Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health.

Revisiting the 2015 IOM Consensus Study, "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk"

A presentation of the recommendations from the 2015 IOM Consensus Study, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, set the stage for workshop discussions and established a reference point for identifying new progress and barriers in data sharing since the report’s release:

Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.

Sponsors and investigators should share the various types of clinical trial data no later than the times specified in this report (e.g., the full analyzable dataset with metadata no later than 18 months after study completion—with specified exceptions for trials intended to support a regulatory application—and the analytic dataset supporting publication results no later than 6 months after publication).

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 employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent.

The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multistakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data.

Perspectives on Current Data Sharing Policies in Practice

Workshop participants considered the current landscape for clinical trial data sharing and reuse, and shared perspectives on current data sharing policies in practice.

Sharing data enables other researchers to generate new analyses and perspectives, which may lead to new insights that serve the public good. While advances may be made through teamwork, the current academic culture may play a role in disincentivizing researchers from sharing data.
Harlan Krumholz, Harold H. Hines Jr. Professor of Medicine at Yale School of Medicine
Trial participants may generally consider data sharing to be beneficial, but often receive little or no information about what will be done with the data that are generated from a given study.
Moses Taylor Jr., Participant from the Systolic Blood Pressure Intervention Trial (SPRINT)

Data Sharing Platforms

Workshop participants presented four examples of clinical trial data sharing repositories, including the Vivli platform, Yale University Open Data Access (YODA), Supporting Open Access for Researchers (SOAR), and ClinicalStudyDataRequest.com (CSDR).

Data sharing platforms should be flexible to meet the needs of individual users; data governance models should incorporate input from a variety of stakeholders.
Rebecca Li, Executive Director, Vivli
The available supply of data available for sharing is greater than the current demand. Accordingly, there is a need to raise researcher awareness about the availability of rich data resources.
Rebecca Li, Executive Director, Vivli and Joseph Ross, Professor of Medicine and Public Health, Yale School of Medicine

Striking a Balance between Benefit/Value and Risk/Cost

Workshop participants offered perspectives on balancing the value and benefits of sharing data with the risks and costs.

Data sharing can help uncover issues (e.g., error, fraud), enable additional analyses, lead to new insights, generate follow on publications, and facilitate collaboration. David DeMets, Professor Emeritus, Department of Biostatistics and Biomedical Informatics at the University of Wisconsin
Clinical investigators tend to collect as much information as possible because they would not want to reach the end of the study and find that an important data element was missing. Jeffrey Drazen, Group Editor, New England Journal of Medicine

Data Interoperability and Platform Usability

Workshop participants considered key barriers to data interoperability and platform usability based on three case examples: 1) population data from cancer prevention trials; 2) individual participant data (IPD) network meta-analysis; and 3) open-access data sharing models.

Data interoperability and platform usability are hampered by insufficient data standardization and collection, and lack of external validity of trial samples. Ernest Hawk, Vice President and division head for Cancer Prevention and Population Sciences, The University of Texas MD Anderson Cancer Center
Challenges that researchers face when attempting IPD meta-analysis include lack of IPD availability, cross-platform incompatibility, and timeframe and practicality issues.Tianjing Li, Associate Professor at the University of Colorado

Infrastructure Sustainability

Workshop participants discussed infrastructure sustainability challenges as key barriers to clinical trial data sharing and reuse.

Designing trials with data sharing in mind (e.g., adhering to data standards prospectively) could help reduce the downstream costs of clinical trial data sharing. Georgina Humphreys, Manager, Clinical Data Sharing, Wellcome Trust
If shared data are not accessed and used by researchers, interest in supporting the infrastructure for data sharing could wane. Pandurang Kulkarni, Chief Analytics Officer and Vice President of Biometrics and Advanced Analytics, Eli Lilly & Company

Challenges and Disincentives for Sharing and Reuse of Data

Workshop participants examined challenges and disincentives for sharing and reusing data.

Expanding the knowledge base about the complex biology of disease involves effective partnerships that enable access to data and expertise Ramin Daron, Vice President for Data Architecture and Technology, Takeda Pharmaceuticals
One challenge for academic clinical researchers is how to meet data access requests following completion of a trial. Matthew Sydes, Professor of Clinical Trials and Methodology, Medical Research Council Clinical Trials Unit, University College London.
Institutions conducting trials often use issues such as participant privacy or the costs of data sharing as excuses for not sharing. Sharon Terry, President and CEO, Genetic Alliance

Finding Value in Sharing Clinical Trial Data: Overcoming Usability and Sustainability Challenges

Workshop participants explored opportunities and potential solutions for overcoming the technical and sustainability challenges identified throughout the workshop.

Data sharing is enabled by planning to share from the start, using standard data formats and facilitating access to resources, including data platforms and people/expertise. Monica Bertagnolli, Professor of Surgery, Harvard Medical School
There is a need to prioritize the sharing of data that clinicians and patients need to use, and reward data reuse for validation and to answer questions that will help clinicians and patients make informed decisions. Mark Helfand, Professor of Medicine, Medical Informatics, and Clinical Epidemiology, Oregon Health and Sciences University

Looking Forward: Incentivizing Data Sharing and Reuse

Workshop participants considered steps needed to incentivize and promote data sharing and reuse.

To be of value, data should be shared in a way that works for data users. Data generators and data users should work together to find solutions to the challenges of data sharing: establishing standards for IPD, providing clarity on data sharing policies across clinical trial sponsors, pooling data by therapeutic area, and developing multistakeholder platforms based on FAIR Guiding Principles (findable, accessible, interoperable, and reusable) Guiding Principles for data management and stewardship. Liz Roberts, Senior Director and Global Public Policy Lead, UCB Biosciences
Open sharing of clinical trial data can help address issues with irreproducibility, which impacts translation of findings to practice and ultimately on patient care. Georgina Humphreys, Clinical Data Sharing Manager, Wellcome Trust
Data professionals – including data stewards, curators, librarians, archivists, and others – are part of the infrastructure that needs to be built up and better leveraged for clinical trial data sharing. Amy Nurnberger, Program Head of Data Management Services, Massachusetts Institute of Technology

Select Publications from the National Academies Related to Clinical Trial Data Sharing

Select Resources from the National Academies on Clinical Trial Data Sharing

Select Activities at the National Academies Related to Clinical Trial Data Sharing

Sharing Clinical Trial Data: An Action Collaborative
This collaborative was established to support coordination and collaboration among stakeholders engaged in data sharing initiatives. It is an ad hoc activity convened under the auspices of the Forum on Drug Discovery, Development, and Translation, Forum on Neuroscience and Nervous System Disorders, National Cancer Policy Forum, and Roundtable on Genomics and Precision Health at the National Academies of Sciences.

Forum on Drug Discovery, Development, and Translation
The Forum on Drug Discovery, Development, and Translation provides a unique platform for dialogue and collaboration among thought leaders in government, academia, industry, foundations, and disease and patient advocacy. The Forum serves as a hub and a catalyst for nurturing new ideas and partnerships and offers a neutral space for stakeholders to advance critical policy discussions on biopharmaceutical innovation nationally and globally.