About the Collaborative 

The Good Clinical Trials Collaborative (GCTC) was launched in June 2020, supported by Wellcome, the Bill & Melinda Gates Foundation and the African Academy of Sciences. The aim of the Collaborative is to develop  guidance to enable and promote informative, ethical and efficient Randomized Controlled Clinical Trials (RCTs).

 

The GCTC has brought together a wide range of individuals and organizations with an interest in and role to play in the design, delivery, analysis and reporting of RCTs, and in implementing the results. This includes those who fund, regulate, design, deliver, or are responsible for RCTs, those who provide audits and quality assurance functions, research organizations, clinicians, participants, ethicists, and lay health advocates. It includes those from a wide variety of sectors (industry, academia, government, charitable, non-governmental organizations, participant and public groups) and settings.

Why is new guidance needed?

There is an unmet need for guidance for RCTs which can be applied to a wide range of healthcare interventions and settings. The new guidance will focus on the underpinning principles of RCTs and enable flexible, innovative, and proportionate approaches to trial design and delivery.

The new guidance is  intended to support all individuals and organizations involved in the planning, conduct, analysis, oversight, interpretation, funding, and regulation of RCTs of any health intervention for any purpose in any setting.

What are the key features of the guidance?

This guidance has been developed to be:

  • Based on key action-guiding scientific and ethical principles, and focused on issues that materially matter to and influence the well-being of trial participants and the reliability of RCT results

  • Clear, concise, consistent and proportionate to the context and setting in which RCTs are being conducted, recognising that there are risks associated with both usual clinical practice and a lack of reliable evidence on intervention effects

  • Forward looking, fostering innovation in health interventions and trial methods, including the appropriate use of routine healthcare data, technologies, and designs

  • Flexible, widely-applicable, utilisable & durable, across disease areas, intervention types, development phases, trial designs, geographies and time.