Lessons learned from two multicentre randomised controlled trials undertaken in pharmacies in community settings: a retrospective project management analysis

Abstract

Background: Community pharmacists are the most publicly accessible health professionals in high-income countries. There is increasing interest in conducting randomised controlled trials (RCT)-the benchmark of original evidence in the medical field-in community pharmacies. However, little evidence exists examining the challenges and opportunities of conducting RCTs in pharmacies, particularly with respect to project management. In this work, we aim to provide a narrative of lessons learned in conducting two RCTs in community pharmacies in two high-income countries.

Methods: We retrospectively reviewed multiple data sources including administrative and trial activity records. We conducted face-to-face and online sessions to create a list of lessons learned from our experiences and created a stakeholder map for the trials examined. We framed our findings using the Project Managements Institute's model of the project life cycle, and descriptive statistics were used to estimate the outcomes reported.

Results: Ninety-six pharmacies were recruited. Across the project phases, seven high-level tasks within Initiation; 30 within Planning, 43 within Execution/Monitoring and Controlling, and 14 in Closure, were identified. Recruitment of pharmacies, developing documentation for trial drug supply, participant recruitment, and negotiation with pharmacy contracting bodies took longest to complete. Eight key stakeholder groups were identified, including public services/agencies; community pharmacies, communications actors; funders/sponsors; universities/research institutes; healthcare providers; suppliers; and regulators. Thirty lessons were identified, most critically across engaging and managing stakeholders; selecting and supporting trial sites; streamlining trial processes to minimise burden; optimising data collection and accuracy; and considering pharmacy constraints and costs.

Conclusions: Conducting RCTs in community pharmacies presents unique challenges across the project life cycle. Key lessons include the importance of early planning, streamlining processes to reduce staff burden, and addressing pharmacy constraints. The complexity of the work necessitates dedicated and well-resourced trial management staff to enhance stakeholder management and offer tailored supports where required.

Trial registration: Not applicable.

Keywords: Community pharmacy; Lessons learned; Project management; Randomised controlled trials.

Fig. 1

Number of high-level tasks linked to clinical trials route map processes across the project phases, providing a summary view of the route map processes with the highest density of high-level tasks. Note: Darker shading denotes a higher number of tasks relative to lighter shading. Processes are sorted alphabetically for each project phase. Abbreviations: E, M, C, Execution, Monitoring, and Controlling; Aus, Australia; NHS, National Health Service

Fig. 2

Timeline with key milestones for the SuperDOT-C trial. Abbreviations: TM, trial management; FPFV, first patient first visit; CT.gov, www.clinicaltrials.gov; LPLV, last patient last visit

Fig. 3

Timeline with key milestones for the Reach trial. Abbreviations: TM, trial management, CT.gov, www.clinicaltrials.gov, FPFV, first patient first visit, UK, United Kingdom of Norther Ireland and Great Britain, LPLV, last patient last visit

Fig. 4

Results of stakeholder analysis showing key actors involved in planning and delivery of clinical trials in community pharmacies. Abbreviations: R&D, research and development