Introduction

In 2023, a powerful alliance was formed between the Association of British Pharmaceutical Industry (ABPI), the Chief Executive and Medical Directors of the Shelford Group, and the R&D leaders of UKRD in the NHS. Their mission was to establish a joint working group focused on identifying the key challenges in their field and creating effective solutions.

This collaborative team has since created and released a best practice guide. This document highlights areas for mutual enhancement, with the primary aim of refining the processes involved in setting up clinical trials in the UK.

Publication Goal

The quest to streamline clinical trial procedures and expedite timelines has been a hot topic on the UK life sciences landscape for few years. The aim to facilitate patients’ access to cutting-edge research, has consistently sparked meaningful dialogues. Vibrant discussions have been ignited among the Association of British Pharmaceutical Industry (ABPI), the chief executive and medical directors of the Shelford Group, and the R&D leaders in the NHS ‘UKRD’.

The Result

Last year, ABPI, UKRD and the leadership of Shelford group, these three collaborating organisations formed a dynamic task group which consisted of top-tier leaders from the NHS Research and Development (R&D) sector and representatives from various pharmaceutical companies. They were united by a common goal, to identify major roadblocks and devise effective strategies to overcome them.

The result of this collaborative endeavour is a comprehensive, best practices guide that they have drafted and released on 13 December 2023. The guide ‘Clinical Trial Best Practice Guide 2024’ shines a light on areas where joint improvements can significantly refine the setup processes for clinical trials in the UK.

The Guide

The guide is divided into four pivotal sections:

Establishing a study’s feasibility

Assessing feasibility is critical in setting achievable and transparent expectations for a study’s completion. If these expectations are met, it can motivate a sponsor to collaborate with the site again in the future.

Confirming a site’s capability and resources

Effective communication between the site and the sponsor is crucial for setting transparent and achievable expectations for a study’s execution, as well as verifying the necessary capacity and capability.

Escalating blockers to study setup and delivery

Establishing clear protocols on whom to contact for escalating any issues related to the set-up or execution of the study is crucial for both sponsors and sites.

Establishing strategic communication between sites and sponsors

It is vital for both sponsors and sites to have well-defined procedures in place on who should be reached out to when concerns arise regarding the study’s set-up or implementation.

List of References

For a copy of the UK Clinical Trials Best Practice Guide 2024, please click here.

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