A Systematic Approach For Synthetic Replication Of Clinical Trial Cohorts Using Retrospective Real-world And Clinical Trial Data

Replication of clinical trials through retrospective data has potential applications ranging from in silico modeling and synthetic control arm™ creation to extrapolation of clinical trial findings to real world practice. In the recently issued Framework for FDA’s Real-World Evidence Program, the potential value of external control arms is noted, for situations where randomization is infeasible or unethical. Applicability to reimbursement and Health Technology Assessment scenarios is also noted in Health Canada’s “Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle” developed in collaboration with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut National d’Excellence en Santé et en Services Sociaux (INESSS).