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.
Thankfully, not all drug regulators have ignored our call for change.
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. This means that a new drug before it is licensed will require much more monitoring than say a drug which is licensed and has been used in a group of patients for some time. Another area where CTTI are doing important work is how trial participants and the public can be more effectively involved in trials.
This work which is ongoing has resulted in a number of improvements in trial regulation and we are continuing to work with CTTI on a number of important issues. Two of us (Trudie Lang & Martin Landray) are members of the Steering Committee for CTTI.