The Guidance for Good Randomized Clinical Trials was developed in collaboration with a diverse, multidisciplinary group of individuals and organizations with a shared commitment to accelerate better healthcare across the world. Grounded by key scientific and ethical principles, our Guidance provides universally relevant, flexible and quality-focused advice for all parties involved with RCTs.
Principle 1 describes the component design characteristics of a RCT that combine to resolve important uncertainties about the effects of a health intervention.
Principle 2 outlines key considerations and expectations that support a trial to fulfil its ethical responsibilities regarding participants, future and current patients, and the public.
Principle 3 addresses the practices and behaviors that help develop trust between all those involved in a trial and contribute to generalized confidence in the clinical trials ecosystem.
Principle 4 outlines the scientific, ethical and efficiency benefits of ensuring that a trial is fit-for-purpose, accounts for and utilizes the inherent characteristics of the trial's setting.
Principle 5 discusses the importance of competent decision-making and coordinated execution, and how good governance and good trial quality management can help achieve these features.