Aims:
To describe the development of a structured credentialing program establishing competency in pharmacy clinical trial delivery at rural and regional hospitals.
Methods:
There is a range of identified barriers to conducting clinical trials in rural/regional hospitals and this includes pharmacy expertise. To expand clinical trial (CT) capacity, a large metropolitan hospital established a partnership with rural/regional hospitals. At these sites, the CT pharmacy department, managing over 300 clinical trials, designed (Sep-Dec 2020) and delivered a CT training program.
The training program was designed using evidence-based teaching methodology grounded in adult learning theory. Competency assessment criteria was established deductively from existing clinical trials guidelines and refined via an iterative process by an expert CT pharmacy team (n=7). A prototype of the program was validated after completion by pharmacists (n= 2) new to clinical trials.
Results:
The training program (launched January 2021) comprised of three credentialing sub-sections: pharmacy site, pharmacist, and clinical trial credentialing. Two major regional hospitals and 10 pharmacists have undertaken the program.
In the pharmacy site credentialing, an initial site visit was performed to assess current candidate site competency. Following implementation of recommended changes, a final site visit assessment was performed to establish provisional competency.
In the pharmacist credentialing, participants completed preparatory self-directed online learning and knowledge assessments followed by experiential onsite training within the developer’s pharmacy CT department. Participant’s provisional competency was assessed using a validated assessment tool and an observed structured clinical examination.
Following site and pharmacist credentialing, the credentialing for individual CTs was undertaken. The candidate site notified the developer about initiation of a new CT. The trial set-up and delivery were assessed to establish the candidate sites' competency to independently manage the trial.
Conclusions:
Rural and regional sites wishing to progress CT pharmacy services should consider the adoption of this formalised credentialing program.