Understand how to optimize recruitment of healthy volunteers in phase 1

Abstract

Background: Phase 1 clinical trials in healthy volunteers (HVs) are a critical step in obtaining information about the safety of a product that is to be marketed. Recruiting HVs to participate in these phases is a challenging but important process. Threats and opportunities have emerged, particularly in the context of the new European Clinical Trials Regulation (EU CTR), which came into force in January 2022, and it is important to implement strategies to address these challenges. In the midst of all the debate on this topic, the question arises as to what can be done in terms of recruitment strategies to get as many HVs as possible into Phase 1 trials. Objectives: The purpose of this work is to examine how HVs recruitment is optimized in real-world settings, how clinical research stakeholders deal with recruitment difficulties, and where it can be optimized. Methods: After acquiring knowledges through the analysis of existing literature and the insights gained from the SWOT analysis, interviews were conducted with various professionals. Individuals were contacted through various channels, including the large database known as Clinicaltrial.gov, as well as contacts in the BAREC and Healexia communities. In all, 9 interviews were carried out. The qualitative nature of this study enabled us to compare what has been seen in the literature with the testimonies and real-life experiences of sponsors, CRAs and PIs, various stakeholders involved at different levels in the recruitment process. Analysis: In general, experts confirm that there are recruitment problems to overcome in Phase 1. Depending on the type of respondent, disparities between answers were sometimes identified. This interesting finding shows that, depending on the position you occupy, you will not have the same ideas for improving the recruitment process. In addition, the EU CTR clearly has consequences for the work of professionals, which seems to have an indirect impact on recruitment in the end. Conclusion: Failing to recruit HVs in the early stages can have serious consequences for the remaining research. But there is no one-size-fits-all solution: the field is constantly evolving, and every trial is different. Perhaps the strategies to be implemented will not be the same from one trial to the next? What is more, it is difficult to really assess the weight of the new EU CTR, as it is a new system that needs a transition period to be fully implemented and used with ease.

Date of Award	19 Jan 2024
Original language	English
Awarding Institution	University of Namur
Supervisor	Benjamin Boinem (Supervisor) & Régis Radermecker (Co-Supervisor)