Research Regulation

CTSU has for many years been actively engaged in trying to ensure that there is appropriate, proportionate and sensible regulation and governance of health research. This involves working with a large number of groups in the UK, Europe and internationally, including government, regulators, funders, industry and other academic collaborators. Increasingly, this work involves direct consultation with the public to better understand through dialogue, debate and discussion how to remove undue obstacles to high-quality health research.

A long-standing area of our work has been to remove inappropriate barriers to the conduct of high-quality randomised trials. Trials regulation and governance has substantially increased in the last two decades (even though there is increasing recognition of the value of having uniquely reliable evidence from trials). Members of CTSU have been actively engaged for a number of years with regulators, governments, funders and other bodies to try to streamline research regulation related to trials. For example, back in 2007, in response to the problems with the ICH-GCP guideline and other trial regulation, we established with trialists from Duke University in the US and McMaster University in Canada the Sensible Guidelines forum. We very deliberately made the forum international and inclusive in an attempt to involve everybody involved in trials and have held three meetings in 2007, 2009 and in 2012.  Some progress was made on improving aspects of trial regulation, but not the fundamental change that was required.

As a result of the first Sensible Guidelines meeting in Washington in 2007, the US Food & Drug Administration (FDA) worked with us and others to create the Clinical Trials Transformation Initiative (CTTI). Through CTTI important and influential recommendations have been developed on a range of issues relating to the conduct of randomised trials. These include the application of Quality-by-Design (QbD) principles, taken from modern industrial manufacturing, to identify in advance those errors that matter when conducting a trial and to design processes to monitor for them. From this, comes the concept of Risk-Proportionate Monitoring, which simply means that the amount of monitoring required in a trial should be proportionate to the risks from the treatments being tested. We are continuing to work with CTTI on a number of important issues. Professor Sir Martin Landray is a member of the Steering Committee for CTTI.

The Good Clinical Trials Collaborative (GCTC) was launched in June 2020 to develop guidance to enable and promote informative, ethical and efficient randomised controlled clinical trials (RCTs). The GCTC has brought together a wide range of individuals and organisations with an interest in and role to play in the design, delivery, analysis and reporting of RCTs, and in implementing the results. The team is based at Wellcome and led by Professor Sir Martin Landray.