Joint Research Office


New best practice guide to improve clinical trials set up processes published

14 December 2023

A new best practice guide aimed at helping to improve the clinical trials set-up process in the UK is published today.

A new best practice guide aimed at helping to improve the clinical trials set-up process in the UK is published today.

The guidance was developed by NHS and industry representatives through a process co-led by UCLH/UCL Managing Director for Research Dr Nick McNally, who is chair of UK Research & Development (UKRD), a representative body for R&D leaders in the NHS.

The guide, a product of collaboration between NHS R&D leaders and senior industry representatives, aims to reduce the amount of time taken to set up research and in so doing to increase patients’ access to research.

It covers best practice in four areas:

  • establishing a study’s feasibility
  • confirming a site’s capability and capacity to deliver the research
  • addressing barriers to study set up and delivery
  • and establishing strategic communication between research sites and sponsors.

The guide was co-developed by a group of R&D leaders in the NHS and senior representatives from several large pharmaceutical companies. The work was coordinated by UKRD, the Association of the British Pharmaceutical Industry (ABPI) and the Shelford.

The need to improve clinical trial set up processes in order to reduce timelines and increase patients’ access to research has been consistently on the UK life sciences agenda for several years.

It has also been highlighted as an area of importance in conversations between UKRD, the ABPI and the Shelford Group.

To address the problem, the three organisations convened a working group of senior NHS R&D leaders and pharmaceutical company representatives to help achieve a common understanding of where the main challenges are, and how they can be addressed.

Dr McNally said: “I’m pleased we are able to publish this guidance today. It has been co-produced by a range of NHS and industry partners, all of whom have been highly engaged in the process and keen to exchange knowledge and experiences, in order to develop practical guidance which research sites and sponsors can use to improve study set-up times. The ultimate aim is to enhance patient access to research and patient benefit from research.”

Read the guideClinical trials best practice guide 2024: Helping to improve clinical trial set-up processes in the UK