Frequently Asked Questions
1. How is this guidance different from other existing guidance? What does it add?
A range of guidelines for clinical trials exist, but most fail to provide guidance on the underpinning principles of randomized controlled clinical trials (RCTs) necessary to generate reliable results safely and ethically, regardless of context. Many guidelines have focussed narrowly on standards required of trials (including non-randomised studies) intended to be submitted to regulatory authorities to support a new drug license. There is an unmet need for guidance to promote the unique benefits of RCTs across all contexts. The Good Clinical Trials Collaborative (GCTC) was established to develop and promote the adoption of new guidance to address this issue.
2. Who do you expect to use this document?
This guidance is intended to support all individuals and organizations involved in the planning, conduct, analysis, oversight, interpretation, funding, and oversight of all trials in which randomization is used to assess the effects of any health intervention for any purpose in any setting. This includes researchers and clinicians; patient and public groups (including trial participants); regulators and other government bodies; ethics committees and institutional review boards; funders; trial sponsors (academic and pharmaceutical); the health intervention industry and those who regulate or provide audit and quality assurance functions.
3. How should this document be used?
This document provides the underpinning principles of good RCTs. It aims to give those involved in RCTs the guidance to ensure they can get a scientifically sound answer to the relevant question in the context of their setting, avoiding unnecessary or in appropriate activities.
A supplemental glossary is in development to explain terms commonly used in the guidance. Illustrative examples of the principles are also being prepared to enable a better understanding of how this guidance can be used in practice
4. Who has written this document?
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, ethicists, clinicians, participants, 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 (including higher and lower income countries around the world).
5. What happened after the consultation process finished?
Following the consultation process, the feedback provided was carefully reviewed and considered by the GCTC coordinating team with input from a global and diverse multidisciplinary group of experts. The feedback helped us carefully refine specific wording and clarify meaning, identify ways to make the guidance more accessible, identify strategic collaborators, and raise the profile, reach and credibility of the guidance.
Following submission for independent review, we expect the guidance to be published later this year and will update the non-English versions of the Guidance accordingly.
6. What activities are planned following publication of the guidance?
In the second phase of the Collaborative's work, our focus will turn to activities that create awareness of the principles, and encourage adoption and implementation. This will require partnership and collaboration with a wide range of national and international organisations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies. We will prioritise:
Endorsement and policy adoption by major research funders.
Endorsement and advocacy support from patient representative groups
Informing updated guidance issued by major regulatory authorities
Application in industry trials sponsored by multinational companies
Development of capacity-strengthening material designed for key implementers