Industry, academia, non-profit organizations and patient advocacy groups are making strides to improve transparency in sharing clinical trial data, in accord with participant wishes. Key principles for responsible data sharing include protecting the privacy and confidentiality—and wishes—of 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.
The MRCT Center is dedicated to examining barriers to clinical trial data sharing and seeks to develop thoughtful and practical solutions driving through multi-stakeholder participation. Examples of our work and publications can be found on this page.
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Global Clinical Trials Data Sharing Platform: Vivli, Inc
Founded through an MRCT Center initiative, Vivli was launched in 2017 as an independent not-for-profit entity to promote global clinical trials data sharing. Vivli has established a data platform wherein data are hosted, searched, and accessed. Vivli is now the largest global clinical trial platform with over 6,300+ clinical trials representing 3.8 million participants available to search and request access.
Academic Credit for Data Sharing
The current system for recognizing academic advancement is predicated on a track record of peer-reviewed publications. Individuals who share data are rarely rewarded academically for making data available to others for secondary analysis, nor are they formally recognized for data preparation and curation. In response to these structural barriers, the MRCT Center, in collaboration with the New England Journal of Medicine and the Association of American Medical Colleges, formed a working group to advance a system of recognition and academic credit for data generators who opt to share their data.
• Credit data generators for data reuse
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 participants 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 has developed a roadmap toward harmonized standards and recommendations for data anonymization.
• Data Anonymization — A keyenabler for clincal data sharing: workshop report.
Tools for Data Sharing
Data sharing allows sponsors and investigators to honor the essential contributions and volunteerism of clinical trial participants, to ensure reproducibility, and to enable the maximal use of data by the research community. Supported by and working with the Patient-Centered Outcomes Research Institute (PCORI) Open Science Pilot Project, the MRCT Center worked to lower the barriers to data sharing by creating harmonized governance templates that further clinical trial data sharing, improve interoperability, and preserve participant privacy and autonomy.
• Template Data Contributor Agreement, for MRCT Center Sponsors: Word document
• Template Data Use Agreement, for MRCT Center Sponsors: Word document
• Template Data Sharing Section of an Informed Consent Form (ICF), for MRCT Center Sponsors: Word document
Individual Patient Data Sharing
Since July 1, 2018 the International Committee of Medical Journal Editors (ICMJE) has required authors to include a data sharing statement at the time of manuscript submission when reporting clinical trial results to journals that follow ICMJE recommendations. More recently, since January 1, 2019 all new clinical trials must include a data sharing statement in the trial’s publicly posted registration. ICMJE recognizes IPD as de-identified, individual participant level data and measurements including tables, figures, and appendices or supplementary material that support the results presented in a manuscript. The MRCT Center has worked to evaluate the understanding and implementation of the ICMJE requirements on the inclusion of data sharing statements at the time of trial registration as well as in patient facing documents, such as the informed consent form.
Related Resources and Publications:
• Primed to Comply: Individual Participant Data Sharing Statements On ClinicalTrials.gov
Statham E. White SA, Sonwane B, Bierer BE, PLOS ONE, February 2020. DOI: 10.1371/Journal.pone.0226143