Background: Patients who participate in randomized controlled trials (RCTs) continue generating a wealth of real-world data (RWD) throughout their routine interaction with the healthcare system before, during, and after a trial. Trial patients’ RWD can supplement active collection of clinical trial data and provide a deeper insight on benefits, risks, and cost of treatments. However, the disconnect between trial data and RWD delays access to critical data ultimately becoming a detriment to patients.
Objectives: We report progression of our collaboration with several trial sponsors for linking their ongoing RCTs to RWD.
Methods: Patients who are enrolled in several clinical trials, were offered to participate in linkage sub- studies. Those who signed informed consent forms provided personal identifiers to enable investigators linking their trial data to their RWD. The process for collecting consent, personal identifiers, and the linkage were integrated into the trial standard electronic data capture (EDC) system to ensure minimizing burden on study site investigators/staff. All linkage sub-studies were approved by respective Institutional Review Boards.
Results: We collaborated with sponsors and implemented trial linkage in the standard EDC system for 5 trials. Study protocols for linkage sub-studies were approved by respective IRBs. A total of 21,377 patients across 213 study sites participating in these five trials are being asked to participate in the linkage sub-studies. Of 4,977 individuals enrolled in one of the trials 4,866 (94%) consented to the linkage process. Capturing outcomes for patients loss to follow-up and healthcare resources utilization data during the clinical trial, and capturing long-term effectiveness and safety outcomes after trial completion were common use cases for trial linkage.
Conclusions: We observed a high success rate in obtaining IRB approvals, seamless integration into standard EDC systems, easy adoption by clinical site investigators/staff, and high patient consent rates for the linkage. This provides supporting evidence on feasibility of design and implementation of clinical trials that are linkable to RWD.
