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 happens after the consultation process finishes?

Following the consultation process, the feedback provided will be carefully reviewed and considered by the GCTC coordinating team with input from relevant experts as appropriate. Amendments will be made to address any factual inaccuracies, key omissions, repetitive or contradictory statements. Any feedback that is specific to certain contextual factors (e.g. particular types of intervention, participant population, or healthcare setting) or which focuses on a particular detail will be reviewed to consider the implications for the wider, principle-based nature of these guidelines (all RCTs of any health intervention for any purpose in any setting).

Once we have reviewed the feedback and modified the guidance document accordingly, a new version will be published on the website, initially in 6 languages (Arabic, Chinese, English, French, Japanese and Spanish).

6. What activities are planned following publication of the guidance?

Following the publication of the guidance in Autumn 2021, our focus will turn to activities that create awareness of the principles, 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.