Single-Arm Trials Can Provide Randomized Real-World Evidence: The Random Invitation Single-Arm Trial Design

They show how RISATs allow fairer access to participation, improve applicability and generalizability of results compared with traditional single-arm trials, and provide a form of randomized real-world evidence. At negligible added cost beyond already existing infrastructure, this approach may catalyze the early generation of evidence of higher value than that produced with traditional single-arm trials, increasing the credibility and validity of accelerated drug approval processes and enabling better health care decisions.