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JKM > Volume 36(3); 2015 > Article
Choi, Uhm, Lee, Lee, Kim, and Kim: Survey Research for Developing Educational Programs on Clinical Trials of Korean Medicine Devices

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.

Table 1.
Demographical Characteristics
Demographical Characteristics Researchers (N=26)

N (%)
Gender Male 15 (57.7)
Female 11 (42.3)

Age 20∼29 6 (23.1)
30∼39 13 (50.0)
40∼49 5 (19.2)
50∼59 2 (7.7)

Degree Master’s course 5 (19.2)
Master 1 (3.8)
Doctorate course 9 (34.6)
Doctor 11 (42.3)

Occupation Korean medicine doctor 23 (88.5)
Etc 3 (11.5)

Affiliation Korean medicine hospital of university 19 (73.1)
Research institution 6 (23.1)
Etc 1 (3.8)

Position Professor 8 (30.8)
Intern or resident 11 (42.3)
Senior researcher of institution 1 (3.8)
Researcher of institution 5 (19.2)
Etc 1 (3.8)

Workplace Seoul 3 (11.5)
Pusan 2 (7.7)
Gwangju 3 (11.5)
Daejeon 4 (15.4)
Gyeongsang-do 14 (53.8)
Table 2.
Clinical Trials Career
Clinical Trials Career Researchers (N=26)

N (%)
<5 year 15 (57.7%)
5 year∼9 year 6 (23.1%)
10 year∼14 year 3 (11.5%)
20 year ≤ 2 (7.7%)
Table 3.
Position of Clinical Trials (Multiple Responses Possible)
Position of Clinical Trials Number (N=35)

N (%)
Principal Investigator 8 (30.8)
Sub-investigator 15 (57.7)
Co-researcher 10 (38.5)
Sponsor 0 (0.0)
Clinical Research Associate(CRA) 1 (3.8)
Clinical Research Coordinator(CRC) 1 (3.8)
Clinical Research Pharmacist(CRP) 0 (0.0)
Etc 0 (0.0)
Table 4.
The Number of Clinical Trials Approved by Ministry of Food and Drug Safety
The Number of Clinical Trials Approved by MFDS* Number (N=70)

N (%)
식약처 임상시험 승인 대상 22 (31.4)
식약처 임상시험 승인 비대상 48 (68.6)

* MFDS: Ministry of Food and Drug Safety

Table 5.
Type of Clinical Trials
Type of Clinical Trials Number (N=19)

N (%)
Pilot study 8 (42.1)
Feasibility study 7 (36.8)
Pivotal trials 3 (15.8)
Post-marketing studies 1 (5.3)
Table 6.
Form of Clinical Trials Using Korean Medicine Devices
Form of Clinical Trials SIT* IIT** Government task
Single center study 2(2.4) 43(51.8) 13(15.7)
Multicenter study 1(1.2) 21(25.3) 3(3.6)

* SIT: Sponsor initiated trial

** IIT: Investigator initiated trial

Table 7.
Items of Korean Medicine Devices (Multiple Responses Possible)
Items of Korean Medicine Devices Number (N=27)

N (%)
한방시술(침, 뜸, 부항 등) 20 (76.9)
한방 의료기기 2 (7.7)
한방 진단기기 4 (15.4)
기타 1 (3.8)
Table 8.
Classification of Korean Medicine Devices (Multiple Responses Possible)
Ratings of Korean Medicine Devices Number (N=26)

N (%)
Class Ⅰ 7 (26.9)
Class Ⅱ 13 (50.0)
Class Ⅲ 0 (0.0)
Class Ⅳ 0 (0.0)
Not sure 6 (23.1)
Table 9.
Target Disease of Clinical Trials (Multiple Responses Possible)
Target Disease of Clinical Trials Number (N=41)

N (%)
Brain-nervous system 6 (14.6)
Cardiovascular system 4 (9.8)
Respiratory system 1 (2.4)
Alimentary system 5 (12.2)
Urogenital system 2 (4.9)
Endocrine system 3 (7.3)
Musculoskeletal 13 (31.7)
Gynecology 2 (4.9)
Pediatric 1 (2.4)
Ophthalmology & Otolaryngology 1 (2.4)
Dermatology 0 (0.0)
Related to a neoplasm 1 (2.4)
Etc 2 (4.9)
Table 10.
Problems of Practice for Korean Medical Clinical Trials (Multiple Responses Possible)
Problems of Practice for Korean Medical Clinical Trials Number (N=67)

N (%)
의료기기 임상시험 관련 법령 및 규정에 대한 지식의 부족 6 (23.1)
식약처 의료기기 임상시험계획 승인 진행 과정의 어려움 5 (19.2)
환자 모집의 어려움 17 (65.4)
연구비 산정 및 관리, 연구비 부족 5 (19.2)
의료기기 임상시험에 대한 교육과 경험부족 7 (26.9)
연구 지원 인력의 부족(임상연구코디네이터 등) 11 (42.3)
모니터링 및 실태조사의 어려움 2 (7.7)
계약, IRB 검토 등 행정적 처리과정에 대한 어려움 4 (15.4)
임상통계, 결과분석에 대한 지식의 부족 6 (23.1)
임상연구 공간의 부족 0 (0.0)
연구 프로토콜 작성 4 (15.4)
이상 반응 관리 및 보고 0 (0.0)
Table 11.
Educational Experience of Clinical Trials
Educational Experience of Clinical Trials Researchers (N=26)

N (%)
Experience 22 (84.6)
Inexperience 4 (15.4)
Table 12.
Educational Experience of Clinical Trials Using Korean Medicine Devices
Educational Experience of Clinical Trials Using Korean Medicine Devices Researchers (N=26)

N (%)
Experience 10 (38.5)
Inexperience 16 (61.5)
Table 13.
Educational Contents of Clinical Trials (Multiple Responses Possible)
Educational Contents of Clinical Trials Number (N=122)

N (%)
의료기기 임상시험 관련 법령 및 규정 13 (50.0)
의학연구 방법론 16 (61.5)
프로토콜 준수, CRF 작성법 11 (42.3)
Regulation 관련 (IMDA 승인, ICH, GCP, KGCP 등) 8 (30.8)
의학연구의 통계분석, Data Management 13 (50.0)
경제성 평가 2 (7.7)
피험자의 권익보호 등 윤리적인 사항 17 (65.4)
의뢰자의 모니터 등 관련자와의 의사소통 기술 4 (15.4)
IRB 관련사항 13 (50.0)
모니터링 점검 및 실태조사 관련 사항 8 (30.8)
임상시험용 의료기기의 관리 7 (26.9)
임상시험 관련문서 작성 및 보관 9 (34.6)
기타 1 (3.8)
Table 14.
Necessity for Educational Programs
Necessity for Educational Programs Researchers (N=26)

N (%)
Necessary 25 (96.2)
Unnecessary 1 (3.8)
Table 15.
Unnecessary Reasons
Unnecessary Reasons Number (N=1)

N (%)
수요가 크지 않음 0 (0.0)
임상연구 교육 프로그램은 필요하나, 의료기기 특화 프로그램의 필요성은 없음 0 (0.0)
기존에 시행되고 있는 임상연구 교육 프로그램으로 충분함 1 (100.0)
교육보다는 임상시험을 진행하면서의 경험이 더 중요함. 0 (0.0)
기타 0 (0.0)
Table 16.
The Reason of Necessity
The Reason of Necessity Number (N=21)

N (%)
의료기기 개발 및 확산을 위하여 특화된 프로그램이 필요함. 9 (42.9)
인력보충을 위해서 필요함. 0 (0.0)
임상시험 진행이 원활해질 것으로 기대함. 6 (28.6)
한의약 임상연구 분야의 발전을 위해서 필요함. 6 (28.6)
기타 0 (0.0)
Table 17.
Needed for Educational Programs of Clinical Trials Using Korean Medicine Devices(Multiple Responses Possible)
Needed for Educational Programs of Clinical Trials Using Korean Medicine Devices Number (N=136)

N (%)
한의약 의료기기 임상시험 관련 법령 및 규정 18 (69.2)
임상시험 연구방법론 12 (46.2)
의학연구 방법론 9 (34.6)
코호트 연구 설계 및 실행 6 (23.1)
RCT 설계 및 실행 9 (34.6)
비교 효과 연구 (Comparative Effectiveness research) 11 (42.3)
경제성 평가 8 (30.8)
중개연구의 개념 5 (19.2)
기초통계분석 13 (50.0)
고급통계분석 5 (19.2)
진단법 평가를 위한 통계분석 8 (30.8)
임상연구에서 교호작용의 평가 및 제시방법 3 (11.5)
Data management 10 (38.5)
적정 표본 수 계산 의미 및 방법 11 (42.3)
임상시험용 의료기기의 관리 8 (30.8)
기타 0 (0.0)
Table 18.
Educational Programs (Clinical Trial Regulations and Institutions) (Multiple Responses Possible)
Educational Programs (Clinical Trial Regulations and Institutions) Number (N=59)

N (%)
식약처 IMDA 승인 및 ICH, GCP, KGCP 등에 대한 사항 17 (65.4)
의료기기 개발, 승인 및 변경 절차 관련 사항 13 (50.0)
IRB 관련사항 13 (50.0)
피험자의 권익보호 등 윤리적인 사항 8 (30.8)
모니터링 점검 및 실태조사 관련 사항 7 (26.9)
기타 1 (3.8)
Table 19.
Educational Programs (Throughout the Clinical Trials and Operations) (Multiple Responses Possible)
Educational Programs (Throughout the Clinical Trials and Operations) Number(N=101)

N (%)
한의약 의료기기 임상시험 관련 규정 17 (65.4)
임상시험 개념 및 유관 기관 또는 부서 역할 10 (38.5)
의료기기 개발과정 9 (34.6)
연구비 관리 및 산정 6 (23.1)
Design of Case report form (CRF) 10 (38.5)
임상시험의 수행, 프로토콜 준수 13 (50.0)
임상시험 관련문서 작성 및 보관 10 (38.5)
의뢰자의 모니터 등 관련자와의 의사소통 기술 5 (19.2)
임상시험용 의료기기의 관리(제조, 포장, 라벨링, 사용 및 관리) 8 (30.8)
이상반응 관리 및 보고 9 (34.6)
R&D partnering with pharmaceutical companies 4 (15.4)
기타 0 (0.0)
Table 20.
Educational Programs (Korean Medicine Specific Sector) (Multiple Responses Possible)
Educational Programs (Korean Medicine Specific Sector) Number (N=74)

N (%)
한의학적 임상연구 방법론 16 (61.5)
한의약 치료 기술의 최신 경향 10 (38.5)
한방의료기기 개발 및 임상시험의 실제 15 (57.7)
한의약 의료기기 임상시험 관련 법령 및 제도 12 (46.2)
한의약 임상시험에서 가이드라인 현황 및 개발 방법 11 (42.3)
한의약 임상시험에서 프로토콜 개발 및 출판 10 (38.5)
기타 0 (0.0)
Table 21.
Training Period
Training Period Number (N=26)

N (%)
One or two days workshop (One-time education) 11 (42.3)
Once a week for 3 months (10∼12 times) 13 (50.0)
Once a week for 6 months (20∼24 times) 2 (7.7)
Etc 0 (0.0)
Table 22.
Courses Characteristics
Courses Characteristics Number (N=26)

N (%)
한의약 의료기기 임상시험 특성과 관련한 내용 위주 6 (23.1)
임상시험 관련 전반적인 내용 + 한의약 의료기기 임상시험과 관련된 특화내용 20 (76.9)
기타 0 (0.0)
Table 23.
Teaching Methods
Teaching Methods Number (N=26)

N (%)
인터넷을 이용한 교육 3 (11.5)
학부과정에서 체계적인 교육 3 (11.5)
실습위주의 교육 11 (42.3)
엄정한 출석관리와 시험 평가가 있는 교육 4 (15.4)
기타 1 (3.8)
Table 24.
Intentions to Use the Clinical Trials Center
Intentions to Use the Clinical Trials Center Researchers (N=26)

N (%)
Willing 25 (96.2)
Unwilling 1 (3.8)
Table 25.
Needed Service for the Clinical Trials Center (Multiple Responses Possible)
Needed Service for the Clinical Trials Center Number (N=119)

N (%)
의료기기 개발 및 허가 관련 자문 15 (57.7)
식약처 의료기기 임상시험계획신청(IMDA*) 승인 관련 자문 19 (73.1)
연구 프로토콜 검토 15 (57.7)
임상연구전담인력(CRC**, CRA*** 등) 지원 16 (61.5)
임상연구전용공간(외래, 병동, 검사실 등) 지원 6 (23.1)
임상연구전용기자재(각종 검사기기) 지원 6 (23.1)
eCRF**** 지원 10 (38.5)
Data management 13 (50.0)
통계 분석 지원 18 (69.2)
기타 1 (3.8)

* 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

1. Kim DY. Study on Standardization Strategies for Globalizing Traditional Korean Medicine. Daejeon University;2010.


2. Nam DH. A Survey of Utilizing Status and Demand for Medical Devices in Traditional Korean Medicine. Journal of Korean Medicine. 2013; 34:1. 69–79.
crossref

3. Woo SM. Development of clinical trial standard protocols on digital coated furred tongue diagnosis system. Chungbuk National University;2014.


4. Moon JS, Kim JY, Ryu YH, Song NK, Kim HJ, Lee JR, et al. Actual Condition Survey and Improvement of Medical Devices in Korea Traditional Medicine. Korean Journal of Oriental Medicine. 2005; 11:1. 119–125.


5. Shin SH, Oh DS, Kim BY, Choi SM. Survey on the Need to Develop Training Educational program for Oriental Medical Clinical Trial. Korean Journal of Oriental Medicine. 2007; 13:2. 127–133.


6. Ko CR, Ku NP, Seol SS. A Comparative Study on the Traditional Medicine Policies between Korea and China: Focused on the Second Korean Medicine Development Plan and the 12·5 Traditional Chinese Medicine Development Plan. Journal of Korea Technology Innovation Society. 2014; 17:2. 421–447.


7. Kwak SY. Study on Judical Precedents Related with Traditional Medical Doctor’s Using Medical Devices. Korean Journal of Medicine and Law. 2014; 15:1. 59–80.


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