Optimizing pharmaceutical management of clinical trials

Abstract

Objectives: The clinical trials pharmacists have an essential role in managing the pharmaceutical part of interventional studies. The primary objective of this article was to provide a template for improving trials management for the growing number of studies without increasing personnel resources.

Material and methods: A retrospective study was conducted between 2016 and 2020 at the service of pharmacy at Lausanne University Hospital in Switzerland.

Results: The number of clinical trials (in progress) managed at the pharmacy increased from 77 to 115 (+49%) between 2016 and 2020. The majority of these studies were in oncology and were sponsored by industry. Therefore, different changes in routine tasks were decided during the 5 years term to meet the above challenge. These modifications allowed to improve pharmaceutical and administrative management of clinical trials, without increasing personnel resources. The management template was accepted by the sponsors, and no issues were mentioned by national and international audit authorities.

Conclusion: Changes could be made in the routine practice of the clinical trials pharmacists to improve the management of studies, while the number of trials is increasing every year.

Keywords: Clinical trials as topic; Clinical trials pharmacists; Essais cliniques; Gestion de la thérapie médicamenteuse; Health care economics and organizations; Investigational drugs; Medication therapy management; Médicaments expérimentaux; Pharmaceutical services; Pharmaciens d’essais cliniques; Services pharmaceutiques; Économie et organisations des soins de santé.