1School of Korean Medicine, Pusan National University
2Center for Comparative Effectiveness Research & Economic Evaluation in Korean Medicine, Pusan National University
3Department of Korean Ophthalmology & Otolaryngology & Dermatology, School of Korean Medicine, Woosuk University
4Department of Oriental Rehabilitation Medicine, National Rehabilitation Center
Correspondence to: 김남권(Nam-Kwen Kim), 경남 양산시 물금읍 범어리 부산대학교 한의학전문대학원 한방 의료 비교효과 및 경제성 평가 연구센터, Tel: +82-55-360-5947, Fax: +82-55-360-5906, E-mail: drkim@pusan.ac.kr
Received August 01, 2015 Revised September 30, 2015 Accepted September 30, 2015
The purpose of this study was to investigate and analyze the demands for educational programs on clinical trials of Korean medicine devices, and develop training programs based on the needs of Korean medicine.
Methods:
This research was conducted targeting 26 volunteer applicants who had participated in clinical trials of Korean medicine devices within the last five years (2010–2015). The survey was carried out between May 1, 2015 and May 26, 2015 via e-mail. After receiving questionnaire replies, the material was established. Using obtained data, frequency analyses were performed using SPSS 20.0 version.
Results:
92% of the researchers who participated in the survey expected introduction of educational programs on clinical trials and anticipated that programs contain information that can meet the needs of each researcher. In addition, according to the analysis, introducing expert certification for clinical trials of Korean medicine devices is necessary, and offering related graduate courses are also needed.
Conclusions:
As a result of this study, researchers had difficulties during clinical trials of Korean medicine devices. If the educational programs were to be developed and institutional frameworks support them effectively, it would prove to be helpful to researchers in clinical trials.
* IMDA: Investigational medical device application
** CRC: Clinical research coordinator
*** CRA: Clinical research associate
**** e-CRF: electronic case report form
Table 26.
Intentions to Use the Paid Service
Intentions to Use the Paid Service
Researchers (N=26)
N (%)
Willing
21 (80.8)
Unwilling
4 (15.4)
Table 27.
Necessity of Expert Certification for Clinical Trials of Korean Medicine Devices
Necessity of Expert Certification
Researchers (N=26)
N (%)
Necessary
12 (46.2)
Unnecessary
4 (15.4)
It is necessary, but too early.
9 (34.6)
Table 28.
Necessity of Related Graduate Courses for Clinical Trials of Korean Medicine
Necessity of Related Graduate Courses
Researchers (N=26)
N (%)
Necessary
13 (50.0)
Unnecessary
4 (15.4)
It is necessary, but too early.
8 (30.8)
참고문헌
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