6ER-013 Evolution of pharmacists’ participation as principal investigators in registered clinical trials: a longitudinal study from 2004 to 2024

<h3>Background and Importance</h3> Hospital pharmacists play a crucial role in clinical trials (CTs), particularly those assessing investigational products for medical purposes. However, the extent of collaboration of pharmacists as principal investigators (PIs) is not well-documented. <h3>Aim and Objectives</h3> This study evaluated the participation of pharmacists as PIs in CTs registered in ClinicalTrials.gov and its evolution over time. <h3>Material and Methods</h3> A retrospective, longitudinal study was conducted on CTs registered between 1 January 2004 and 30 September 2024 on ClinicalTrials.gov. Non-interventional studies and those lacking investigator data were excluded. Variables collected included trial phase, intervention design, masking, CT start date, investigator qualifications, and trial status. Data were analysed across 4 year intervals and processed using Python 3.12. <h3>Results</h3> Out of 309,744 CTs, trial phases were distributed as follows: 50,423 (16.28%) in early phase-1/phase-1, 51,414 (16.60%) in phase-2, 28,994 (9.36%) in phase-3, and 26,205 (8.46%) in phase-4; others did not specify phases. Intervention designs included 184,213 (59.70%) parallel, 86,958 (28.18%) single-group, 24,751 (8.02%) crossover, 8,361 (2.71%) sequential, and 4,267 (1.38%) factorial. Masking was categorised as 174,046 (56.34%) open-label, 45,063 (14.59%) single-blind, 40,150 (13.00%) double-blind, 20,812 (6.74%) triple-blind, and 28,837 (9.34%) quadruple-blind trials. Regarding trial status, 27,042 (8.73%) were inactive, 48,394 (15.62%) recruiting, 161,411 (52.11%) completed, 30,780 (9.94%) stopped, and 42,117 (13.60%) had unknown status. Notably, only 2,080 trials (0.67%) included a pharmacist as PI, with 1,875 trials having one pharmacist, 172 having two, and 33 involving more than two. Plot 1 presents trends in participation rates of academic and professional groups from 2004 to projections into 2024 and later. <h3>Conclusion and Relevance</h3> This study reveals persistently low pharmacist participation as PIs in ClinicalTrials.gov-listed trials. The low participation may stem from limited professional recognition, specific training gaps, and institutional biases favouring physicians for such roles. Addressing these challenges could involve enhancing pharmacists’ training, advocating for institutional policy changes, and increasing awareness and support from professional organisations. These measures could help elevate the role of pharmacists in clinical trials. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest