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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, the Guidance provides universally relevant, flexible and quality-focused advice for all parties involved with RCTs.
A range of guidelines for clinical trials exist, but most fail to provide guidance on the underpinning principles of RCTs necessary to generate reliable results safely and ethically, regardless of context.
There is an unmet need for guidance to promote the unique benefits of RCTs across all contexts and settings. The Good Clinical Trials Collaborative was established to develop and promote the adoption of guidance to address this issue.
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.