Survey Research for Developing Educational Programs on Clinical Trials of Korean Medicine Devices

Article information

J Korean Med. 2015;36(3):84-97

doi : https://doi.org/10.13048/jkm.15022

Ik-Soo Choi ¹, Tae-Woong Uhm ², Dong-Hyo Lee ³, Go-Eun Lee ⁴, Sin-A Kim ², Nam-Kwen Kim ²^,

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 2015 August 01; Revised 2015 September 30; Accepted 2015 September 30.

Abstract

Objectives:

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.

Keywords: Korean medicine device; clinical trial; educational program

Table 1.

Demographical Characteristics

Table 2.

Clinical Trials Career

Table 3.

Position of Clinical Trials (Multiple Responses Possible)

Table 4.

The Number of Clinical Trials Approved by Ministry of Food and Drug Safety

Table 5.

Type of Clinical Trials

Table 6.

Form of Clinical Trials Using Korean Medicine Devices

Table 7.

Items of Korean Medicine Devices (Multiple Responses Possible)

Table 8.

Classification of Korean Medicine Devices (Multiple Responses Possible)

Table 9.

Target Disease of Clinical Trials (Multiple Responses Possible)

Table 10.

Problems of Practice for Korean Medical Clinical Trials (Multiple Responses Possible)

Table 11.

Educational Experience of Clinical Trials

Table 12.

Educational Experience of Clinical Trials Using Korean Medicine Devices

Table 13.

Educational Contents of Clinical Trials (Multiple Responses Possible)

Table 14.

Necessity for Educational Programs

Table 15.

Unnecessary Reasons

Table 16.

The Reason of Necessity

Table 17.

Needed for Educational Programs of Clinical Trials Using Korean Medicine Devices(Multiple Responses Possible)

Table 18.

Educational Programs (Clinical Trial Regulations and Institutions) (Multiple Responses Possible)

Table 19.

Educational Programs (Throughout the Clinical Trials and Operations) (Multiple Responses Possible)

Table 20.

Educational Programs (Korean Medicine Specific Sector) (Multiple Responses Possible)

Table 21.

Training Period

Table 22.

Courses Characteristics

Table 23.

Teaching Methods

Table 24.

Intentions to Use the Clinical Trials Center

Table 25.

Needed Service for the Clinical Trials Center (Multiple Responses Possible)

Table 26.

Intentions to Use the Paid Service

Table 27.

Necessity of Expert Certification for Clinical Trials of Korean Medicine Devices

Table 28.

Necessity of Related Graduate Courses for Clinical Trials of Korean Medicine

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