There is a continued movement of policies and guidelines that call for more open sharing of both summary and participant-level clinical trial data. The MRCT Center is working with sponsors, funders, regulators, and participants to enable increased access to clinical trials data.
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.
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
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. Read More
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 roadmap toward harmonized standards and recommendations for data anonymization. Read More
Harmonized Governance 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 is lowering the barriers to data sharing by creating harmonized governance templates that further clinical trial data sharing, improve interoperability, and preserve participant privacy and autonomy. Read More
Informed Consent Language
Informed consent is a core requirement of ethical human subjects research. Regulatory bodies often require that several key pieces of information be provided to potential research participants. The MRCT Center has facilitated several practical approaches to enhancing the communication and comprehension of clinical research information. By equipping research participants with coherent, intelligible information about clinical research, we strive to uphold the foundational ethical principles of informed consent. Read more
Return of Aggregate Results
Sharing the summary results of a clinical trial with participants involves communicating, in plain language understandable to the participants, the results of the trial and the outcome of the study as a whole. The MRCT Center developed a multi-stakeholder solution to enable returning results to participants and created useful principles, tools, and guidance for the clinical trial community. Read more
Health Literacy in Clinical Research
Developing tools for health literacy in clinical research is an extension of the MRCT Center’s work on returning aggregate results to research participants. Read more.
Return of Individual Results
Patients desire to receive both individual and aggregate research data from clinical studies in which they participated. Standard guidelines and criteria to facilitate return of individual results (including study arm information, research data, incidental findings and genomic data) were lacking. The MRCT Center developed principles, recommendations, and a toolkit for sponsors and investigators to assist in creating these important participant facing materials. Read more.
Global Clinical Trial 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. Through collaboration with Microsoft Health and BlueMetal, the Vivli platform will revolutionize the way that data are discovered, protected, and shared. Read More