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DIA session focuses on the ins and outs of returning individual participant data.
In a session at DIA moderated by Jean Sposaro, program lead, TransCelerate BioPharma Inc. and director, global drug development operations industry collaborations, Bristol Myers Squibb, participants discussed a variety of topics revolving around how to return participant data in clinical trials.
Sposaro started the conversation by asking, “Why now?” Why is now the time to empower participants and return their data? There has been increased awareness and understanding around the value of participant data in addressing unment medical needs. There is also momentum from advancements in clinical data collection and digital health options designed to reduce burden on stakeholders.
David Leventhal, enterprise clinical trial data sharing lead, global data dissemination, Pfizer, said that there is no sugar-coating the operational challenges involved with returning participant data, however, none of them are insurmountable. He continued by explaining to the audience Pfizer’s Participant Data Return program. It involves established best practices for health information exchange and data sharing and designing a digital data return capability that allows participants to securely access data in various formats.
Sylvia Baedorf Kassis, program director, MRCT Center of Brigham and Women's Hospital and Harvard discussed some of MRCT’s initiatives for returning participant data. She emphasized preliminary planning as well as changing language in consent forms so participants have a better understanding of their data.
There was also discussion of facilitating an “architecture” around returning participant data led by Johanna Blom, professor, Univ. Modena and Reggio Emilia. There must be careful consideration of legal and ethical principles, leading up to governance, use of evidence, then at the top of this hypothetical structure: technical implementation.
In the final part of the discussion, Veronique Poinsot, project leader, IMI-FACILITATE, emphasized “striking a balance” between accountability, transparency, legal alignment, ethical framework, and confidentiality. Stakeholders must also be flexible, adaptative, fair, inclusive, and decisions must be based on trust.
Leventhal concluded by stressing collaboration in this process of returning participant data. “Only if we’re all doing it,” he said.
Returning Individual Participant Data: A Cultural and Operational Shift Towards Personalized Clinical Trial Options June 28, 2023. DIA 2023, Boston.