Background:
A regional hospital growing its clinical trial capacity and capability sought to develop its clinical trials pharmacy workforce and infrastructure. At baseline there were no dedicated clinical trials pharmacists and clinical trial activity was absorbed into existing clinical pharmacist workloads. It was determined that 70% of trials needed to be commercially sponsored for future sustainability of the service.
Objective:
To improve equity of access to clinical trials with investigational medicinal product (IMP) for people living in regional, rural and remote locations by establishing a clinical trials pharmacy service.
Action:
Three clinical pharmacists undertook a clinical trial pharmacist credentialling program provided by an interstate clinical trials pharmacy service, comprising of a five-day professional placement, e-learning modules, ClinCat and verbal assessments. Site credentialling was undertaken via a site visit which provided recommendations to comply with regulatory and sponsor requirements. Subsequently, lockable ambient and refrigerated storage of IMP with 24-hour continuous temperature monitoring was installed. New processes and systems were implemented including earlier engagement with pharmacy staff and a standardised assessment for IMP which required above standard of care service; new clinical trial sites in dispensing software with systematic IMP nomenclature utilising the unique ethics number; quality assurance processes documented in standard operating procedures; and a revision of the clinical trials pharmacy fee schedule published on-line.
Evaluation:
The credentialled pharmacists were allocated to clinical trial roles: 1.2 full-time equivalent (FTE) at the hospital and 0.4FTE at the on-site cancer care centre. Over a two-year period they supported the activation of 10 new clinical trials across both services with 7/10 (70%) commercially sponsored.
Discussion:
Pharmacist credentialling and improvements to pharmacy infrastructure and processes supported the growth of clinical trials pharmacy services, promoting equitable access to clinical trials for people in regional, rural and remote locations, and financial sustainability of the service.