임상연구 약사를 위한 교육 및 자격인증 프로그램에 관한 설문조사

Current Status and Preferred Model of Clinical Trial Education and Certification Program for Clinical Trial Pharmacists: A Questionnaire Survey

The current status and preferred model of clinical trial education program and certification system for clinical trial pharmacist(CTP) were evaluated through a questionnaire survey. The questionnaire sheets were sent to 150 CTPs in 100 medical centers where clinical trials are permitted by KFDA. The survey was conducted for 3 months from October 1 to December 31, 2005. The 63 CTPs from 46 medical centers respondents our questionnaire (response rate was 42% for CTP, 46% for medical center).92.1% of the respondents were female, and 58.7% were ranged from 31 to 40 years old (average 34.7+/-6.0). Their working periods at hospital of 0-4.9, 5-9.9 and 10-14.9 were 28.6%, 30.2% and 26.7%, respectively. But 90.5% of them have been working as CTPs for less than 5 years. 84.1% of them have experiences to participate in any clinical trial education program, but only 49.1% of participants were satisfied with the education program. The main reason of low satisfaction was the lack of systematic program and absence of certification system of CTP in Korea. The number of medical centers providing clinical research related services was 44, which were consisted of 14 secondary hospitals, 5 tertiary general hospitals and 25 tertiary university hospitals. Among 44 medical centers, 16 hospitals (36.4%) have clinical trial centers, of which 6 hospitals (37.5%) have pharmacies in clinical trial centers. The contents for the future education program were selected by the survey. And also all 63 CTPs wanted to participate at the well organized clinical trial education program, they preferred midterm (about 3 months) (46%) and short-term periods (39.7%). The 92.1% of CTPs wanted to introduce the certification program of CTPs who took the required clinical trial education program. They also preferred KFDA (50.8%) and academic associations (15%) as operating organization for the certification program. From the results of these study, it was found that the well organized clinical trial education program is needed to increase the quality of CTPs, and also surveyed data will be used to develop the contents of training materials.