Title: Putting the ‘Good’ into Good clinical practice

Abstract

The Guideline for Good Clinical Practice (ICH GCP) is beingrevised to address concerns about its utility, but this may take years. In this article, we showcase existing examples of sensible and workable national policy for clinical trials inEurope, the United States and Australia. We highlight that ICH GCP is not a legal requirement in any of these regions andcall for the ICH Committee to build into the next version of ICH GCP, the flexibility already present in many national regulatory frameworks.Whilst the principles laid down in ICH GCP form the bedrock for trial conduct internationally, we examine whether some of its detail is truly evidence-based. We also question whether a Guideline co-created by the PharmaceuticalIndustry and Regulators can ever reflect the views of the stakeholders it impacts. Flexibility in the way ICH GCP is applied is especially critical for low-risk, comparative effectiveness trials. These trials have the potential to rapidly improve public health and reduce the healthcare cost but are currently mired in levels of bureaucracy that unnecessarily hamper the generation of the evidence needed to do so. We use key trial activities, including informed consent and safety reporting to illustrate how a proportionate approach to regulation could create an agile framework that facilities these trials whilst still protecting trial participants.

Biography

Tanya Symons has worked in the field of clinical research for over 25 years as a researcher and as a government consultant in the United Kingdom and Australia. Her outputs include the National Institute of Health Research (NIHR) Clinical Trials Toolkit, an internationally recognised resource designed to help researchers navigate the complex regulatory requirements for clinical trials. In Australia, she has authored several national guidelines including the National Health and Medical Research Council (NHMRC) Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods, the Australian Clinical Trial Alliance’s Consumer Involvement and Engagement Toolkit and co-authored the Therapeutic Goods Administration (TGA) Australian Clinical Trials Handbook.Tanya has also provided Good Clinical Practice training to many biomedical research organisations in the UK and Australia. Her current research interest (and the topic of her PhD) is using proportionate consent models in a Learning Healthcare System.