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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 which 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:

Framework for Data Sharing
There has been a call for an increased level of data sharing from regulatory agencies, journal editors and other key stakeholders. The MRCT Center focused our multi-stakeholder base on providing a forum for discussion of the rationales, barriers and implications of this paradigm change and to formulate potential solutions to serve a wider audience of data generators and data requestors. Read more

Vivli
Vivli promotes clinical data sharing with enhanced data discovery methods, hosting data, and bridging to other established repositories. Vivli is a not-for-profit entity that will promote global clinical trial data sharing through the establishment of a data platform where data can be hosted, searched, and accessed.  Read more.

Return of Aggregate Results
Returning results refers to providing clinical trial participants with plain language summaries of the trial results, information about the outcome of the study as a whole, and potentially a more detailed description of the individual participant’s study arm. 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. Read more.