Clinical trial regulation should be simplified - Researchers call for ‘toolbox’ to bridge the gap between governance and reality -

London, 12 July 2024 – Governance and their practical implementation in early phase clinical trials require a new approach and simplification is the route to better safety according to an article in the latest issue of the British Journal of Clinical Pharmacology[1].

The editorial authors, Dr Ulrike Lorch, co-founder and Chief Medical Director at Richmond Pharmacology and Charles Vincent, Professor of Psychology, Oxford University and Emeritus Professor Clinical Safety Research, Imperial College London, state that the overarching principle in clinical trial regulation should be to achieve “lean processes that can be easily understood and followed”. Early phase clinical trials are becoming more complex but instead of adding more documents and checklists, there should be a “toolbox” of practical standards and guidelines which, used with agility, will bridge the gap between regulation and reality. The authors make a number of recommendations in the editorial including:

• Having experienced Investigators and clinical researchers well represented in the development of relevant regulations and guidelines.
• Creating modules of regulation and regulatory guidance which can be updated more frequently to counteract the current lag in clinical trial practice.
• Standardization via adaptive and current modular work instructions and process maps. Incremental changes through customization, optimization and continual improvement process.
• Intelligent compliance monitoring, which focuses on overarching concepts and frameworks, while allowing flexibility of local practical implementation.
• Clinical trial specialists with a greater understanding of human factors and the ergonomics approaches that are used in other industries to develop effective safety management systems.
• On-demand and flexible learning and development curricula that can be tailored to the scope of work of investigators and researchers.
• Certification for sites, researchers and investigators resulting in faster regulatory authorization timelines for trusted organisations and personnel.

The authors cite a recent trial examining work practices in a clinical research facility during a SARS CoV2 controlled human infection model[2] as an example of the challenges in translating regulation and guidelines into practice. Human factors researchers summarised that this trial was governed by “thoughtful and well-intentioned standards guidelines” and that those leading the trial followed these guidelines to the best of their ability. They identified a number of risks to patients and staff including points where the guidance was not well implemented or impossible to follow and a variety of challenges in the design of the facility which potentially compromised safety.

Dr Lorch and Professor Vincent write that: “Early phase trials are becoming increasingly heterogeneous, and this requires a different approach to standards and guidelines akin to the ‘mass customisation’ seen in industry.¹³ Mass customization allows products to be made to individual customer requirements but is only achievable because each of the many components is built in a standard fashion with rigorous quality control.”

However, they conclude that while standards and guidelines are necessary, they are not sufficient to maintain trial safety even in the most professional hands. They recommend that safety and compliance should be combined with agility in adapting to change and innovation. And that to achieve this, a whole new generation of researchers will need to be trained to manage risk and protect patients in “the rapidly evolving landscape of early phase trials.”

-Ends-

Notes to Editor:

About Richmond

Richmond is a leading UK CRO, founded in 2001, specialising in first-in-human studies and adaptive clinical trials for gene editing and gene silencing therapies. In 2021 it was first in the world to treat a patient with the Nobel Prize-winning CRISPR-cas9 gene editing tool and currently has more patients undergoing cutting-edge genetic trials than any other clinic in the world. It has completed more than 500 early phase studies and helped deliver 30 medicines to market - including drugs for heart failure, hypertension and cancer. Clients include top 10 pharma, genetic engineering and biotech companies from around the world, especially Europe, the USA and Japan. In 2020, Richmond founded the Richmond Research Institute to advance understanding of under-researched diseases.

For more information, please contact Linda Rose: linda@denhams.digital 07788 592842

 

[1] Lorch U, Vincent C The safety of early phase clinical trials: Bridging the gap between governance and practice. Br J Clin Pharmacol.2024 https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.16141

[2] Higham HE, Morgan L, Cooper C, et al. Adopting human factors in early phase and experimental medicine research: a nested pilot study observing controlled human infection with SARS-CoV-2. Br J Clin Pharmacol. 2023. https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.15949

³Hou S, Gao J, Wang C. Design for mass customisation, design for manufacturing, and design for supply chain: a review of the literature. IET Collab Intell Manuf. 2022; 4(1): 1-6. doi:10.1049/cim2.12041