Developing a framework for the ethical design and conduct of pragmatic randomized controlled trials
2017 - 2021
To make informed decisions, patients, health providers and health system managers need reliable evidence of treatment safety, effectiveness and cost. Pragmatic randomized controlled trials (RCTs) are designed to provide such evidence by evaluating treatments in real-world conditions. But pragmatic RCTs raise difficult ethical issues that challenge researchers and research ethics committees. Our research team, comprising 25 philosophers, trialists and biostatisticians from five countries, will develop guidance for the ethical design and conduct of pragmatic RCTs.