Good healthcare needs good evidence from good trials
Good randomized controlled trials (RCTs) provide reliable evidence that enables informed changes in healthcare practice. It must be made easier to do good RCTs to inform future care.
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.
The Collaborative submits commentary on draft GCP E6(R3) guidelines to regulators
Good Clinical Trials Collaborative
Good trials are
Good trials are
01 · Informative and relevant
Principle 1 describes the component design characteristics of a RCT that combine to resolve important uncertainties about the effects of a health intervention.
02 · Respectful of participants
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.
03 · Collaborative and transparent
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.
04 · Appropriate for their context
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.
05 · Efficient and well managed
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.
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