Experience in Implementing Clinical Trial to Real-World Data (RWD) Linkage

OBJECTIVES: Patients who participate in clinical trials are rarely connected to their real-world data (RWD). Trial patients’ RWD can supplement active data collection in trials and provide additional insight on the benefits, risks, and cost of treatments to help patients, physicians, and decision makers. We report the effort needed for implementing linkage of multiple clinical trials to RWD in collaboration with several trial sponsors.

METHODS: Patients who are enrolled in several ongoing clinical trials were offered to participate in linkage sub-studies. The process for collecting informed consent, personally identifiable information (PII) and tokenization was integrated into the trial standard electronic data capture (EDC) system to minimize burden on study site investigators/staff. All linkage sub-studies were approved by respective Institutional Review Boards.

RESULTS: We reviewed implementation efforts needed for linking a subsample of 11 trials for 5 sponsors. These trials enrolled more than 103,300 participants and spanned multiple indications in oncology, cardiovascular, metabolic disorders, antivirals, and diagnostics. Linkage was implemented in the United States study sites of these trials; Median duration from contract execution to start of PII collection for linkage sub-studies was 19 weeks (IQR:15-30.5). This duration is reduced from initial deployments (27.5 weeks [IQR:20.5-35.3]) at each sponsor to subsequent deployments (15 weeks [IQR: 15-19]). Number of meeting hours (Median, IQR) different organizational roles spent for implementation were: Director 6h (IQR:3.5-11), Trial Lead/Manager 6h (IQR:3-12), Data Manager 2h (IQR:0-10), Real-World Evidence Lead 2h (IQR:1-9), and Technical/IT Lead 0h (IQR:0-2).

CONCLUSIONS: We observed an acceptable level of effort required across different trials/sponsors for implementing trial linkage substudies and efficiency gains from scaling data linkage across trials. The process of integration into standard EDC systems was seamless and easily adopted by clinical site investigators/staff. Early planning and inclusion of informed consent language for linkage are key to facilitate trial linkage.