Category: Professional Posters
Purpose: According to the National Institute of Health (NIH), South Korea has a cumulative total of 10,092 clinical trials from 2000 to 2019 March, which is 6th in the world. There is a regulation stating that investigational products (IPs) should be handled by clinical trial pharmacist with appropriate qualification, but there is no regulation with regards to the standard of human or institutional resources needed for clinical trials. The aim of this study is to examine the current status of clinical trial pharmacy (CTP) and analyze the role of a clinical trial pharmacist, to provide evidence for the establishment of standards.
Methods: We collected data on clinical trials conducted at Samsung Medical Center CTP from 2014 to 2018, and identified the number of initiated tasks, the number of tasks to be carried out, the number of drugs administered, the task management status, and the activities of the pharmacist. In addition, from January to May 2019, the pharmacist's work history was classified according to the ASHP standard, and the time and work ratio were analyzed.
Results: A total of 1,009 study protocols were managed from 2014 to 2018, and the average number of protocols was 684. The number of IPs increased 115% from 2,280 in 2014 to 2,615 in 2018, and refrigerated or frozen products increased 146% from 540 in 2014 to 788 in 2018. The average length of the protocol was 4 years.
According to the analysis of clinical trial pharmacist's work from January to May 2019, an average monthly initiation visits were 14 cases, pharmacy management fee calculation 21 cases, dispensing guide setting 14 cases, receipts 367 cases, preparation 2,192 cases, CRA monitoring 238 cases, IPs return and disposal 66 cases, audit and inspection were 4 cases.
Based on the calculation of the time required, it was analyzed that each pharmacist could manage 59 studies.
Conclusion: Recently, research design has become more complicated and diverse, and the work of clinical trial pharmacist is increasing. The clinical trial pharmacists must be able to meet the needs of clinical trial tasks, ensure the safety of study subjects, and protect the integrity of clinical research data. For this reason, it is necessary to develop the standard indicators so that the necessary support can be provided according to the appropriate evaluation of the work specificity of the clinical trial pharmacist.