P216: Implementing Clinical Trial to Real-World Data (RWD) Linkage

Poster Presenter

Mehdi Najafzadeh

Senior Director
Medidata AI
United States

Objectives

Trial participants’ real-world data (RWD) can supplement active data collection in trials and provide additional insight on the benefits, risks, and cost of treatments. Trials, however, are rarely linked to RWD. We report the effort needed for implementing linkage of multiple clinical trials to RWD

Method

Patients enrolled in several ongoing 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 site burden.

Results

All linkage sub-studies were approved by respective InstitutionalReview Boards. 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 UnitedStates 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 (27.5weeks [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).

Conclusion

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.