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Data Transparency

Data Transparency

Data Transparency

Context

Recent shifts in regulatory policy call for more open sharing of participant-level clinical trial data. The MRCT Center is working with sponsors and regulators who are striving towards enabling increased access to clinical trials data.

Challenge

Key principles for responsible data sharing should be carefully considered, including protecting research participants, balancing risks with benefits, making data disclosure feasible by avoiding undue burdens on data generators and requestors, providing timely access to data in a format convenient for end-users, and ensuring adequate transparency and accountability. In addition, ethical data sharing necessitates careful review of informed consent language to determine whether and how uses of data were originally communicated to trial participants.

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MRCT Center Projects
In this focus area, we examine barriers to clinical trial data sharing and seek to develop thoughtful and practical solutions driven through multi-stakeholder participation.

Current projects in this area include:

Academic Credit for Data Sharing
Increasingly, biomedical sciences are a data-driven endeavor. When publications rely on data that have been previously generated and shared, the contributions of the original data generators are not recognized in a systematic and standardized way. Therefore, in collaboration with the Association of American Medical Colleges and the New England Journal of Medicine, the MRCT Center seeks to develop the criteria and system for recognition of generators of data in a way that is meaningful, appropriate, standardized, and accepted by researchers, academic institutions, journals, and funders.

Balancing Data Anonymization with Data Utility
Efforts to facilitate and promote clinical trials data and document sharing rely, in part, on the effective anonymization of clinical study reports. Although existing policy guidelines acknowledge a range of methods to prevent identification of subjects after publication of study documents, concrete standards and recommendations for data anonymization are largely absent. Together with the European Medicines Agency (EMA), the MRCT Center is working to develop a glossary of key terms and a roadmap toward harmonized standards and recommendations for data anonymization—a process that must preserve and maximize data quality and utility insofar as possible.

Harmonized Governance Tools for Data Sharing
As part of the Patient-Centered Outcomes Research Institute (PCORI) Open Science Pilot Project, the MRCT Center seeks to lower the barriers to data sharing by creating harmonized governance templates that furthers clinical trial data sharing, improves interoperability, and preserves participant privacy and autonomy.

Return of Aggregate Results
Returning results refers to providing clinical trial participants with plain language summaries of the trial results, and information about the outcome of the study as a whole. . The MRCT Center developed a multi-stakeholder solution to lowering barriers for returning results and creating useful tools and guidance for the clinical trial community. Read more

Return of Individual Results
Patients desire to receive both individual and aggregate research data from clinical studies in which they participated. For return of individual results (genomic data, incidental findings and study arm information) standard guidelines and criteria to facilitate this process are lacking. The MRCT Center brought together a multi-stakeholder group to develop principles, recommendations and a toolkit.  Read more. 

Real World Evidence
In partnership with OptumLabs, the MRCT Center launched project OPERAND (Observational Patient Evidence for Regulatory Science and uNderstanding Disease) to develop empirical evidence for the use of real world data studies for regulatory science and medicine. The MRCT Center is also working with the Duke-Margolis Center on the Real World Evidence Collaborative.

Representation of Diverse Populations
In most clinical trials across the globe, sex and ethnicity are underrepresented and not representative of the population at large. While there is a general appreciation that “more should be done” to ensure race/ethnicity and gender/sex diversity in clinical trials, methods to enhance diverse representation have not been rigorously inventoried or tested and there is no systematic set of recommendations or guidelines to increase diversity in multi-regional clinical trials. The MRCT Center is convening a workgroup to develop systematic guidance on increasing diversity in global clinical trials.

Global Clinical Trial Data Sharing Platform: Vivli, Inc.
Founded through an MRCT Center initiative, Vivli was launched as an independent not-for-profit entity that will promote global clinical trials data sharing. Vivli is establishing a data platform wherein data can be hosted, searched, and accessed. Through collaboration with Microsoft Health and BlueMetal, the Vivli platform will revolutionize the way that data is discovered, protected, and shared.