Transparency

Context

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.

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.

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.

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. The group worked 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 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.  Read More

Return of Aggregate Results
Returning the summary results of a clinical trial to participants involves communication,–in language understandable to the participants—of the results of the trial and the outcome of the study as a whole. The MRCT Center and its collaborators developed resources to lower barriers for returning results to participants, created a number of useful tools, and published a 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
Participants desire to receive both individual and aggregate research data from clinical studies in which they participated. For the return of individual results (including routine results, incidental findings, individual endpoints and study arm information, and exploratory findings) standard guidelines and criteria to facilitate this process 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. 

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. . 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. Vivli is now the largest global clinical trial platform with over 5,000 trials available to search and request access. Read More