Objectives: Public access databases achieve dissemination of clinical trial design and aggregated results. However, return of participant-level data is rarely done. A key barrier includes the proprietary ownership of data by the sponsor. Additionally, investigators may not have access to centralized data, and per ICH Good Clinical Practice, must maintain the confidentiality of participants. This study piloted an approach to return both individual and aggregate clinical trial data to parents of children participating in a series of open-label clinical trials.
Setting and Design: A small biotech company obtained central ethics approval (Western
IRB, non-exempt). The study was advertised via parent advocacy groups. Parents of trial participants were offered the option to contact an employee (coordinator) within the company, requesting return of their child’s study results. Ethics approval covered participation in 6 countries.
Interventions: Contact initiated by the parent enabled the coordinator to obtain informed consent (and separate GDPR consent), with phone translation when needed. Using date of birth and study site location provided by the parent, the data manager reported the participant number to the coordinator. The coordinator retrieved and compiled data, along with an aggregate summary, which was mailed via a password protected and encrypted memory device to the parent. Pre-and post-return surveys were sent to consented parents (n=19; 40% of 48 total trial participants) and investigators. Results: Pre-return surveys indicated a request for as much data as offered, in all formats offered. Post-return survey showed high satisfaction with the process and data returned. Survey of the physician site investigators (n=10; 100% participation of investigators) voiced general satisfaction with the process, with some reservations.
Conclusions: This pilot study demonstrates an innovative, simple, and labor conservative approach to return of participant-level and aggregate data to participants in studies.