Pharmacy Resident Miami Cancer Institute Miramar, Florida, United States
Poster Abstract:
Background: Guidelines have stressed the importance of Investigational Drug Service (IDS) in clinical research. Drug accountability, adherence assessment, adverse reaction reporting, and patient education are among the duties of an IDS. Measuring IDS pharmacists’ productivity is complex due to varied responsibilities. Unlike traditional roles, an IDS pharmacist's responsibilities vary based on trial complexity, and regulatory requirements. The duration of trial activation steps depends on trial phase, therapeutic area, and institutional requirements. A survey, which involved 105 global clinical trials encompassing multiple therapeutic areas, found that the duration from receiving final sponsor-approved protocol to site activation required 10 months for phase I studies and 16.7 months for phase II/III. Lack of timely trial initiation could halt a site’s participation, lead to higher expenses, and hinder patients’ access to trials. Efficient trial initiation sets the foundation for the clinical trial process, impacting accrual targets, and resource allocation. Assigning the appropriate staffing and resources to support trial initiation can be enhanced by establishing and measuring the right pharmacy metrics, but there is limited data on benchmarks that a research pharmacy can use to assess its efforts.
Objectives: Develop productivity metrics that include key aspects of the IDS trial activation process. Collect productivity metrics to evaluate time allocation for tasks required for IDS trial activation. Identify bottlenecks and provide recommendations to enhance the quality and timeliness of the IDS trial activation process.
Methods: This is a quality improvement project focusing on time assessment studies. A process map was created to outline key steps in the IDS pharmacy trial activation process. The time that each pharmacist takes to complete each trial activation step will be measured and recorded between October 2023 to February 2024.The time dedicated to datasheet development, regimen validation, drug accountability, and other key components of the trial activation process will be recorded in minutes. Descriptive statistics encompassing median and range values will be used to characterize the trial activation metrics and will be further stratified by trial-type These metrics will be used to create a metrics capturing system in our pharmacy clinical trial platform. The metrics captured will be used to establish benchmarks, identify bottlenecks for workflow improvement and provide recommendations on how to enhance the quality and timeliness of the IDS trial activation process.
Results: Pending
Discussion: Pending
Conclusion: Pending
References (must also be included in final poster): HOPA Investigational Drug Service Best Practice Standards. Hoparx.org. Accessed July 24, 2023. https://www.hoparx.org/documents/109/HOPA16_IDS_Guidelines.reviewed_2018.pdf
ASHP guidelines for the management of Investigational Drug Products. Available at: https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/management-investigational-drug-products.ashx.
Mark SM, Weber RJ. Advanced practice programs in Hospital Pharmacy –Investigational Drug services. Hospital Pharmacy. 2008;43(2):143-148. doi:10.1310/hpj4302-143
Bentley C, Cressman S, Van Der Hoek K, Arts KE, Dancey J, Peacock S. Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review. Clinical Trials. 2019;16(2):183-193. doi:10.1177/1740774518820060
Lamberti MJ, Brothers C, Manak D, Getz K. Benchmarking the study initiation process. Therapeutic Innovation & Regulatory Science. 2013;47(1):101-109. doi:10.1177/2168479012469947
Song K, Yu M, McLuckie R, et al. Development of complexity categories for an investigational drug services complexity scoring tool to assess pharmacy effort in clinical trial initiation and maintenance. American Journal of Health-System Pharmacy. 2023;80(21):1557-1563. doi:10.1093/ajhp/zxad138
