Generalizability of clinical trial efficacy results to a real-world population: An example in migraine prevention.

ABSTRACT:

Background

Health care decision makers are often concerned about the external validity of randomized controlled trials (RCTs), as their results may not apply to certain patients in the real world who intend to receive treatment.

Objective

To demonstrate a methodology for assessing the generalizability of clinical trial results to a real-world population, before sufficient and appropriate real-world effectiveness data are available, using individual patient-level data from an RCT and aggregated baseline data from a real-world French registry in migraine.

Methods

The analyses were conducted in 2 steps. First, individual patient-level baseline data from the multinational CONQUER RCT were weighted to match aggregated real-world InovPain registry patient characteristic dat

SUBMITTER: Paget MA 

PROVIDER: S-EPMC10776265 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature