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.
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.
| Original language | English |
|---|---|
| Article number | 461 |
| Number of pages | 14 |
| Journal | Trials |
| Volume | 26 |
| DOIs | |
| Publication status | Published - 31 Oct 2025 |
Keywords
- Randomised controlled trials
- Lessons learned
- Project management
- Community pharmacy