Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.

摘要: Background New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional board (IRB) evaluation more complex. In this manuscript, key components of "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" trial that required a reappraisal IRB submission, review, approval are discussed. Main text ADAPTABLE is pragmatic, multicenter, open-label RCT evaluating comparative effectiveness two doses aspirin widely used for secondary prevention (81 mg 325 mg) 15,000 patients with an established history atherosclerotic cardiovascular disease. The electronic informed consent form completed online by participants at time enrollment, endpoint ascertainment conducted through queries health records. challenges encountered regarding centralized evaluation, consent, patient engagement, risk determination described manuscript. experience encapsulates how protocol intended to facilitate study conduct have been tempered unexpected, justified concerns raised local IRBs. How lessons learned can be applied future similar delineated. Conclusion Development engaging communication channels between personnel as early design allows reduce issues approval. Integrations process IRBs, emulated will instrumental studies.