Good Clinical Trials Collaborative: guidelines for Randomized Controlled Trials

The Good Clinical Trials Collaborative (GCTC), currently hosted by Wellcome, is completing the first phase of the project during which it has developed new global guidance for the delivery of Randomised Controlled Trials.

Phase 2 will focus on the uptake and application of the guidance by all groups of key stakeholders in the clinical trials sector, including major regulators, clinical researchers, funders of trials including industry and those supporting clinical research in LMICs such as Wellcome and BMGF.

Success for the GCTC project is wide adoption and utilisation of the guidance principles, both through established channels (e.g. updates to ICH or major Regulatory Authority guidance and practice that closely reflect the GCTC principles) and (where appropriate) through direct adoption and utilisation of GCTC guidance for relevant settings/jurisdictions.

Successful delivery of this project will lead to better evidence of health interventions across all settings including challenging areas such as vaccines, mental health, common communicable diseases and particularly in LMICs.

Protas, a new, independent, not-for-profit company, created to design and deliver appropriately large randomized trials that address key patient care and public health needs, has offered to host the GCTC moving forward as Wellcome embarks upon its new organisational strategy.