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Good Clinical Trials Collaborative launches new guidance consultation

The Good Clinical Trials Collaborative has launched a 6-week consultation on new guidance for the conduct and regulation of randomised controlled trials (RCTs).

To read the new guidance and share your feedback, please visit the Good Clinical Trials Collaborative.

The Good Clinical Trials Collaborative was set up in 2020 with funding from the Wellcome Trust, The Bill & Melinda Gates Foundation and the African Academy of Sciences to develop guidance to promote and enable good RCTs. It has brought together a wide range of people and organisations with an interest in and role to play in the design, delivery, analysis and reporting of RCTs, and in implementing the results. 

The new draft guidance published today, aims to support people and organisations involved in the planning, conduct, analysis, oversight, interpretation, funding, and regulation of RCTs of any health intervention for any purpose in any setting.

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. These principles underpin the randomised trials funded by NIHR, the way that NIHR infrastructure supports delivery of research and the training it offers to people involved in the delivery of studies at research sites. For more information and to sign up to one of our courses, visit our Good Clinical Practice (GCP) page.

Professor Andrew Farmer, Director of the NIHR HTA Programme, said “This clear set of principles focusses on the core scientific and ethical standards that can inform innovative trial design and transform trial conduct. This period of consultation is important to ensure that the guidance being proposed is appropriate and proportionate."