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However, the over-interpretation of confusing or outdated guidelines has driven up costs through waste, delay and failure, and reduced the availability of proven and affordable treatments for many important health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 guidelines are needed to support a more effective regulatory environment for clinical trials – enabling researchers to efficiently conduct the trials that are needed to improve patient care.
Launched in June 2020, the Good Clinical Trials Collaborative, supported by grants from Wellcome, the Gates Foundation(opens in a new tab) and the African Academy of Sciences(opens in a new tab), will review the principles of randomised clinical trials for all types of healthcare interventions, in all settings.
The new guidelines will:
To inform the new guidelines, we ran 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 barriers and challenges that have affected others.
We'll also be consulting with a range of stakeholders – from the patients and public who volunteer for clinical trials, to the organisations that provide the skills, funding and infrastructure to conduct research.
We'll publish the results by the end of 2020, and hold a series of public events that will give stakeholders the opportunity to discuss the findings and the work of the Good Clinical Trials Collaborative.
The Collaborative will publish draft guidelines for consultation in early 2021. The final guidelines will be published in spring 2021.