Good healthcare needs good evidence from good trials. However, evidence is too often unreliable or does not exist.
This is because RCTs were never done, those that were done failed to produce scientifically robust or clinically relevant answers, or their results were never published. This has reduced the availability of proven and affordable treatments for many health conditions or resulted in the continued the use of ineffective or hazardous interventions.
Recognizing the need to address the root causes of the issue, the Good Clinical Trials Collaborative brought together a diverse, multidisciplinary group of more than 100 expert individuals and organizations to identify and describe the key underpinnings of a good clinical trial. Now published on the Collaborative’s website, the Guidance is the first ever to be universally relevant to all RCTs of any health intervention, purpose and setting, and is intended to support all parties involved in the journey of an RCT.
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 RCTs necessary to generate reliable results safely and ethically, regardless of context.
Many guidelines have also focused narrowly on standards required of trials (including non-randomized 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 and settings. The Good Clinical Trials Collaborative was established to develop and promote the adoption of new guidance to address this issue.
Who do you expect to use this Guidance?
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.
How should the guidance 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 available on this website 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.
Who has written this Guidance?
The Collaborative 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.
These include 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 also 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).
What happened after the public consultation process?
After a public consultation that ran for two months in the summer of 2021, the feedback was reviewed and considered by the Collaborative’s coordination 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.
The final version of the Guidance is now available on our website and free to download by anyone.
What activities are planned following publication of the Guidance?
In the second phase of its work, the Collaborative will 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 organizations, including patient, professional, academic, and industry groups, funders and government organizations, and ethics, health policy, and regulatory bodies. We will prioritize:
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.