Good Clinical Trials Collaborative

Results from well-designed randomised clinical trials tell us the difference between a promising medical intervention and a proven treatment. Their results inform patient care and public health. 

Researchers running clinical trials must comply with a complex system of regulations and guidelines that aim to reduce risk, provide clarity and standardise approaches. 

However, the over-interpretation of confusing or outdated guidelines has driven up costs through waste, delay and failure, and reduced the availability of proven and affordable treatments for many important health conditions. 

New guidance is needed to support a more effective regulatory environment for clinical trials – enabling more informative, ethical and efficient trials to improve patient care. 

Launched in June 2020, the Good Clinical Trials Collaborative, supported by Wellcome, the Gates Foundation and the African Academy of Sciences, are reviewing the principles of randomised clinical trials for all types of healthcare interventions, in all settings. 

The new guidance will: 

• be grounded in scientific principles
• be easy to understand 
• be proportionate and flexible 
• be generalisable  
• promote critical thinking and innovation. 

To inform the new guidance, we have:

• run a survey to hear from researchers whose trials had been impacted by the Covid-19 pandemic. The aim was to capture the innovative practices that have enabled some trials to continue and the challenges that have affected others. 
• consulted with a range of stakeholders, including clinical trial volunteers in Africa, Asia and Latin America, representatives of patient groups in Europe and North America, and more than 100 multidisciplinary experts.  

The public consultation period is now open. Visit the Good Clinical Trials Collaborative website to share your views on how well we have met our objectives, and how we can improve the guidance. The consultation will close on Wednesday 15 September 2021, 23:59 BST. 

The Collaborative will publish the survey report and final guidance in autumn 2021.  

The team is based at Wellcome and led by Professor Martin Landray, Nuffield Department of Population Health, University of Oxford. 

Our steering group gives strategic advice to shape the work of the Collaborative.

If you have any questions about this work, contact goodtrials@wellcome.org.

• Find out more on the Good Clinical Trials Collaborative website.
• You can join our mailing list by emailing goodtrials@wellcome.org with the subject ‘Subscribe’. The option to unsubscribe will be available in subsequent mailings.