국내외 가이드라인 비교분석을 통한 국내 실사용자료 가이드라인 개발 우선순위 도출 연구 = priorities for developing domestic real world data guidelines through comparison of domestic and international guidelines

국문 초록 (Abstract)

한국은 의약품 규제의사결정에서 실사용자료(Real world data, RWD) 및 실사용 증거(Real world evidence, RWE)를 활용하기 위해 노력하고 있지만 실현되기에 아직 해결되어야 할 과제들이 많다. 본 연구는 미국, 유럽 및 국제기관에서 개발된 RWD/RWE 가이드라인을 국내 현황과 비교하여 국내 RWD/RWE 가이드라인 개발 우선순위를 도출하고자 하였다. 우리는 총 미국의 11개, 유럽의 11개, 기타 국제기관의 9개, 한국의 3개 가이드라인을 조사하였으며 국내외 개발현황의 격차확인을 위해 조사한 가이드라인을 주제에 따라 다음과 같은 6가지 기준으로 분류하였다: 1) RWD/RWE 프레임워크, 2) RWD 활용 연구수행 방법, 3) RWD 품질 및 표준화, 4) RWD 활용 연구 관련 양식, 5) 특정 데이터 중심 및 6) 특정 대상자 중심 RWD 가이드라인. 연구결과, 고품질 RWE를 생성하기 위한 전반적인 프레임워크가 가장 우선적으로 제시되어야 하며 점차 개념 중심에서 실무 중심의 가이드라인으로 확대해 나아갈 수 있도록 노력해야 한다.

다국어 초록 (Multilingual Abstract)

Korea has recently made efforts to utilize real world data and real world evidence (RWD/RWE) in pharmaceutical regulatory decision-making, but several challenges must be resolved for realization. We sought to compare the status of guidelines in the United States, Europe, and other international organizations with the guidelines of Korea for identifying priorities in domestic RWD/RWE guideline development. We reviewed a total of 34 guidelines, 11 from the United States, 11 from Europe, 9 from other international institutions, and 3 from Korea. The investigated guidelines were classified by six criteria based on their topics: 1) RWD/RWE framework, 2) Methods for conducting RWD study, 3) RWD quality and standardization, 4) Formats for RWD study, 5) Guideline focused on specific RWD, and 6) Guideline focused on specific population. As a result, a framework for generating high-quality RWE is needed as a priority to utilize RWD in regulatory decisions. In addition, it is necessary to gradually expand the characteristics of guidelines from theoretical-oriented to practice-oriented.

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