ACPE UAN: 0475-0000-23-021-L04-P - A knowledge-based activity
ACPE logo The European Association of Hospital Pharmacists (EAHP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
More information: https://www.eahp.eu/congresses/acpe
Self-assessment questions:

Question Title

* 1. Investigational medicinal products (IMPs) in investigator initiated clinical trials (IICTs)

Is this statement for investigator initiated clinical trials (IICTs) true or false?

In IICTs delays are a common problem of varying causes (e.g., slow recruitment of participants). Prolonged study duration requires the planning and production of additional batches of IMPs - as shelf life of the IMPs may be shorter than the extended study duration.

Question Title

* 2. Role of hospital pharmacies in investigator initiated clinical trials (IICTs)

Is this statement for investigator initiated clinical trials (IICTs) true or false?

Collaboration between hospital pharmacies, clinical research groups, and clinical trial units once established does not need to be adapted to different clinical research projects as the roles and responsibilities are universal for all clinical research projects.

Question Title

* 3. Ensuring the blinded assessment

Is this statement about blinded assessment true or false?

If it is not possible to provide investigational medicinal products (verum and placebo) in a blinded manner for technical reasons, the project should be discontinued.

ER2 - Clinical trials - getting actively involved

Link to EAHP Statements
Section 1 - Introductory Statements and Governance: Statement - 1.5
Section 2 - Selection, Procurement and Distribution: Statement - 2.6
Section 3 - Production and Compounding: Statement - 3.2
Section 6 - Education and Research: Statement - 6.5

ACPE UAN: 0475-0000-23-021-L04-P - A knowledge-based activity

Abstract
Many hospital pharmacists are involved in clinical trials with medicinal products in their hospital. If a pharmaceutical company is the sponsor of the trial, the role of the hospital pharmacist covers mostly the logistics, storage and reconstitution of the investigational medicinal product (IMP). These basic routines, if performed in clinical trials, come with additional tasks regarding the drug accountability, the traceability, or the blinding of the IMP.

If hospital pharmacists are involved early in the planning of academic clinical trials, their contribution goes far beyond the above-mentioned tasks. Some clinical questions require blinded administration of the drugs being evaluated to ensure an unbiased assessment of effect. Although this fact is recognised by experts in clinical trial methodology, the availability of blinded drugs can be difficult and may require some trade-offs, or may even result in the discontinuation of research projects.

Particularly in the academic setting, pharmacists can make important contributions in developing IMPs tailored to the research question and in determining the appropriate strategy for blinding and emergency unblinding. As specialists for the production of medicinal products, hospital pharmacists also compile the IMP-related documentation for the submission to the competent authorities.

This seminar will provide the basic knowledge to perform these additional tasks and give examples of successful interprofessional collaboration. Besides, it will give insight into the design and realisation of investigator initiated clinical trials (IICTs) in the hospital setting and the challenges investigators and pharmacists may face during planning and conducting clinical trials.

Learning objectives
After the session, the participant should be able to:
  • Evaluate a clinical research project in terms of pharmaceutical requirements for the development and production of investigational medicinal products (intervention, comparator) in open or blinded manner
  • Outline the key factors to be considered in organising the drug-related processes within a clinical trial
  • Assess the different tasks and interprofessional interfaces in planning and conducting clinical trials (from the perspective of hospital pharmacists)
Educational need addressed
Hospital pharmacists need to know details regarding the design of investigator initiated trials with medicinal product and potential difficulties during the conduct of a clinical study in order to support the investigator with organising the medication related tasks.

Keywords: Clinical trial, randomisation, blinding, investigational medicinal product, manufacture

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