Sponsoring a clinical trial
When a non-commercial organisation (such as a hospital or academic institution) takes on sponsor responsibilities for a clinical trial, there are a number of regulatory and legislative responsibilities they must comply with. Some organisations will have dedicated Sponsor pharmacy teams that are integrated into the Research and Innovation Departments. Others will seek Pharmacy support from their local site Pharmacy team.
This series of articles provides guidance to aid clinical trial sponsors in identification of tasks which require completion when undertaking the role of the sponsor pharmacy.
Defining the sponsor
For the purposes of this document, the term Sponsor includes the non-commercial Sponsors in primarily NHS sites, but may have close university partners that they Co-Sponsor with or charity partners that the NHS team undertake Sponsor work on behalf of.
Regulation of clinical trials
The European Union (EU) Good Clinical Practice (GCP) Directive 2001/20/EC was introduced to establish standardisation of research activity in Clinical Trials throughout the European Union. It was transposed into UK law as the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) which came into force on 1st May 2004. The Medicines for Human Use (Clinical Trials) Regulations together with subsequent amendments will be referred to as the Regulations in the rest of this document.
All clinical trials involving investigational medicinal products (IMPs) must be conducted according to the principles of GCP.
Purpose
The purpose of this resource is to:
- Outline the key areas where Sponsor should focus pharmaceutical expertise in the set up and conduct of a CTIMP sponsored by their organisation
- Ensure there is appropriate oversight of the IMP-related aspects of the trial from a Sponsor point of view
- Acknowledge this is different from the day-to-day management of pharmacy related aspects of trials, which is the responsibility of the clinical trials lead pharmacist at each site.
This document should be read in conjunction with the National Pharmacy Clinical Trials Advisory Group – Professional Guidance on Pharmacy Services for Clinical Trials, endorsed by RPS (Royal Pharmaceutical Society) Version 2.1, April 2019 or subsequent amendments. Within this document, the ‘Sponsor Lead Pharmacist’ will be referred to. Where local practices allow this may be a role delegated to another appropriately qualified member of the pharmacy team as appropriate.
Studies with non-CTIMPs
Studies supported by non-commercial Sponsors which involve medicines but are classified as non-CTIMP are outside the scope of this document. It is recommended that consideration be given to the level of risk each of these studies poses and the level of oversight and management the pharmacy department may need to commit to ensure participant safety, on behalf of the Sponsor. Decisions relating to this are advised to be made in conjunction with the Sponsor team.
Process Overview
This series of articles describes a process flow outlining key requirements when sponsoring a clinical trial whilst ensuring appropriate pharmacy oversight for NHS sponsored CTIMPs. There are a series of downloadable appendices to be used as guidance for implementing effective IMP management oversight, which are also linked at the bottom of this page.
Supporting documents
Templates have been produced for local use to assist the sponsor in performing specific tasks.
Appendix 1: division of responsibilities
To allocate roles and responsibilities to key stakeholders.
Appendix 2: IMP risk assessment
To complete a risk assessment related to IMP activities. Sponsor pharmacy input is required.
Appendix 3: quality technical agreement
To agree technical and quality parameters when outsourcing any aspect of IMP manufacture or supply.
Appendix 4: pharmacy site feasibility form
Feasibility form to determine if sites can deliver a trial