Pharmacy Assurance Pilot: Streamlining Study Setup in Early-Phase Oncology Trials

28 Apr 2025

Background

The UK is committed to becoming a world leader in clinical research through the UK Clinical Research Delivery (UKCRD) programme. On behalf of all four UK nations, DHSC has led a sector-wide plan through the UKCRD programme to streamline and reform the set-up and delivery of clinical trials as a key priority.

While progress has been made in accelerating regulatory approvals, delays in site set-up remain a challenge, particularly in commercial research.

Pharmacy services play a crucial role in trial set-up but often face capacity pressures. Technical reviews designed to ease this burden are underutilised in early phase oncology trials or inconsistently applied, preventing its full potential from being realised.

Aims of the Work

The Experimental Cancer Medicine Centres (ECMC) Network, in collaboration with the Health Research Authority (HRA), is delivering a targeted programme of work under Workstream 2 of the UK Clinical Research Delivery (UKCRD) Study Set-Up Plan. This workstream focuses on reducing unnecessary duplication in pharmacy technical review and improving the effectiveness and consistency of technical assurance. Together, the ECMC Programme Office and HRA are leading a pilot to test a streamlined study setup pathway and mandated UK Pharmacy Assurance process within early phase oncology trials via the ECMC Network. The pilot will generate insights to support wider adoption across other disease areas and clinical trial phases.

This work aims to:

Simplify and standardise study site selection and set-up processes for both sponsors and sites.
Clarify what information is needed from sponsors and sites, when, and in what format.
Remove duplication of UK study-wide pharmacy review at individual sites and enhance the effectiveness and application of pharmacy technical review information.
Test new approaches to reduce duplication of tasks, streamline trial set-up, and ease the operational burden on local site teams.

This initiative does not aim to replace essential local quality assurance or compliance activities.

About the Pilot

Starting June 2025, the pharmacy pilot will include:

A framework for guidance and support to promote collaboration between sponsors and sites.
Use of the current technical assurance process with targeted improvements:

Lead reviewers must be from participating ECMC trial sites.
Clear guidance on sponsor provided information during site selection.
Early engagement of site R&D and pharmacy teams.
Enhanced technical review form to cover ATMPs, GMOs, and multi-location transport.
Improved handling of amendments.

Study Types for the Pilot

All early phase oncology trials through ECMC sites.
Both commercial and non-commercial trials.
Amendments for trials previously using pharmacy technical assurance.
Excludes trials involving healthy volunteers.

Next Steps

Training for sponsors and ECMC centres Pharmacy and R&D teams begins in May 2025. Technical assurance training is also available.

This pilot is an important step forward in support of the Government commitment to transform clinical trials set-up, to accelerate the development of the medicines and therapies of the future, for the benefit of patients.

Please contact Neil Bhattacharjee, ECMC Project Manager for further information: neil.bhattacharjee@cancer.org.uk and pilot.testing@hra.nhs.uk referencing ECMC pilot.