국내 의료기기
제조업체들의 임상시험 활성화 방안 연구 = A Study on Efficient Ways to Vitalize of Clinical
Trials by Korean Medical Device Manufacturers
| 저자 |
이기준 |
| 발행사항 |
서울
: 동국대학교, 2017 |
| 형태사항 |
iv,
65p. ; 26 cm |
| 일반주기명 |
지도교수:
조성구 |
| 학위논문사항 |
학위논문(석사)--
동국대학교 : 의료기기산업학과 2017. 8 |
| DDC |
610.28 |
| 발행국 |
서울 |
| 언어 |
한국어 |
| 출판년 |
2017 |
| 주제어 |
Medical
Device,Clinical Trial |
| 소장기관 |
동국대학교
중앙도서관 (211020) |
| 초록 |
The
global medical device market is expected to grow by 6.5% on average from 2009
to 2019 at BMI Espicom, and the medical device industry is becoming more
important as the demand for medical devices increases dramatically due to
aging and economic growth.
However, medical devices of
domestic manufacturers have low reliability and poor competitiveness in terms
of quality and performance compared to imported devices due to lack of
clinical data even in domestic market. Although the system or infrastructure
for clinical trials has already been established and operated, it can be seen
that the utilization of infrastructure is considerably deteriorated.
Therefore, this study investigate to improve the infrastructure of existing
medical device clinical trials.
Through the questionnaire survey of
practitioners of domestic medical device manufacturers and interviews of
medical device clinical experts, we confirmed that the infrastructure for
vitalizing medical device clinical trials was not stabilized and needed to be
improve. There was a common
requirement for improvement in the medical device clinical trial support
project. In order to maximize the effect of the infrastructure, it was
confirmed that internal measures such as the appointment of a separate person
to conduct the clinical trial work of the domestic medical device
manufacturer or the adoption of the clinical expert were concurrently
confirmed.
Although Korean medical device
manufacturers have increased their interest in clinical trials compared to
the past, since the preparation of the company and the infrastructure are
still not effective. Therefore, improvement of infrastructure is necessary by
improving the quality of clinical trial education to meet the requirements of
the industry, institutional easing, and long-term cost/ technical support of
clinical trial support projects through government support.
|
| 목차 |
제1장
서론 1
제1절 연구의 배경과 목적 1
1.1 연구의 배경 1
1.2 연구의 목적 8
제2절 연구의 범위 및 방법 10
제2장 국내 의료기기 임상시험 정책 분석 11
제1절 국내 의료기기 임상시험 선행 연구 11
제2절 국내 의료기기 임상시험 운영 현황 13
2.1 의료기기 임상시험 관리 제도 13
2.2 의료기기 임상시험 인프라 16
제3장 의료기기 임상시험 분석 20
제1절 국내 의료기기 임상시험 분석 20
1.1 국내 의료기기 제조·수입 업체 현황 20
1.2 국내 의료기기 임상시험 현황 20
1.3 국내 의약품 임상시험과의 비교 23
제2절 해외 국가별 의료기기 임상시험 건수 비교 24
제3절 자료 분석 결과 26
제4장 의료기기 임상시험 활성화 방안 분석 28
제1절 설문 조사 28
1.1 설문 조사의 방법 28
1.2 설문 조사 결과 28
제2절 의료기기 임상시험 전문가 심층 인터뷰 36
2.1 심층 인터뷰 개요 36
2.2 심층 인터뷰 결과 37
제3절 설문 조사와 심층 인터뷰 고찰 39
제5장 결론 및 연구의 한계점 41
제1절 연구의 결과 41
제2절 연구의 한계점 42
참고 문헌 43
ABSTRACT 45
부록 1. 47
부록 2. 49 |
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