Good clinical practice guidelines for clinical trials

The Academy, Bill & Melinda Gates Foundation and Wellcome Trust have published the note of a workshop looking at Good Clinical Practice (GCP) guidance for clinical trials.

The current ongoing revision of the ICH GCP guidelines provided an opportunity for this workshop to review the application of ICH GCP to trials and experiences of applying this in different settings.

The research community has previously expressed concern around the misapplication and misinterpretation of ICH GCP guidelines. These concerns were outlined in the Academy’s report ‘A new pathway for the regulation and governance of health research’, and continued to be voiced five years on at the Academy, Cancer Research UK and Wellcome’s joint follow up FORUM workshop. In addition, the recently published Life Sciences Industrial Strategy recommended that ICH GCP was reviewed and modernised to support clinical trial capabilities today.

Therefore this workshop, held in March 2018, explored experiences of applying good clinical practice, including for different types of trials and in different research settings such as infectious disease studies in low and middle income countries.

There was concern from some participants that ICH GCP may have raised the cost and bureaucracy of trials without necessarily adding value, and that the clinical research landscape has evolved since the guideline was introduced for drug registration trials. Instead, there were suggestions that good clinical practice should be tailored to better fit purposes of individual trials to ensure relevance and quality, rather than a one-size-fits-all approach.

In addition, participants heard about the continued misinterpretation and inappropriate application of ICH GCP guidelines to non-registration trials, which demands a broader culture change amongst the research community, funders and regulators.

Next steps are being discussed by the meeting sponsors.

The meeting note can be downloaded from the righthand side of this page. Please contact us for further information.