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Published on: September 20, 2019
Current status and future directions for clinical trials pharmacy
Hyen-Oh La1, Sun Choi, Soo-Kyung Lee
1Department of Pharmacology, College of Medicine, Catholic University of Korea, Seoul, Korea. blue27@hanmail.net
Summary
Clinical trials pharmacy in Korea needs more staff, as workload increases. Hospitals require at least one Clinical Trials Pharmacist (CTP) per 40 protocols and diversified training.
Area of Science:
- Pharmacy Practice
- Clinical Trials Management
- Healthcare Human Resources
Background:
- Hospital pharmacies play a crucial role in clinical trials.
- Investigational Drug Services (IDS) are essential for trial integrity.
- Current staffing levels may not meet increasing clinical trial demands.
Purpose of the Study:
- To assess the current status of clinical trials pharmacy in Korean hospitals.
- To identify human resource needs and suggest future directions for CTPs.
- To analyze the relationship between workload, CTP staffing, and IDS performance.
Main Methods:
- A 32-item survey was distributed to 96 hospital pharmacies in Korea.
- The survey collected data on general clinical trial status and IDS performance.
- Statistical analysis was performed on the collected data.
Main Results:
- A 59.4% response rate was achieved.
- 61.8% of respondents handled all regulatory Investigational Drug Services (IDS).
- The need for additional CTPs was felt when active studies exceeded 35, with higher workload and efficiency in 'needs reinforcement' groups.
Conclusions:
- CTP roles should become specialized within hospital pharmacy.
- A minimum staffing ratio of one CTP per 40 protocols is recommended.
- Diversified CTP education, including basic and advanced courses, is necessary based on IDS performance.
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