이전|다음

암 분야 표적 시험 에뮬레이션: 현재 사용 현황과 미래 방향

  • role： Contribute equally, First author同等贡献者, 第一作者
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Hui-Yao Huang1,  
  • role： Contribute equally同等贡献者
  • Affiliation：

    Department of Cancer Prevention, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou 310022, China

Le Wang2,  
  • Affiliation：

    Global Statistics and Data Science, BeiGene, Shanghai 200001, China

Sheng Xu3,  
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Shuo-Peng Jia1,  
  • Affiliation：

    School of Statistics, Renmin University of China, Beijing 100872, China

Dan-Dan Kong4,  
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Xue-Jing Zhang1,  
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Si-Qi Wang1,  
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Han-Qing He1,  
  • Affiliation：

    School of Public Health, Qingdao University, Qingdao 266071, Shandong, China

Hao-Ran Chen5,  
  • Affiliation：

    Minzu University of China, Beijing 100081, China

Lu-Zhu Xia6,  
  • Affiliation：

    Department of Clinical Research Management, the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou 450008, China

Lan-Wei Guo7,  
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

Yu Tang1,  
  • Affiliation：

    Department of Cancer Prevention, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou 310022, China

Ling-Bin Du2,  
  • role： Corresponding author通信作者
  • Affiliation：

    Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China

  • Email：ncctrials@cicams.ac.cn
  • Introduction：* Ning Li ncctrials@cicams.ac.cn
Ning Li1*

추상적인

표적 시험 에뮬레이션(TTE)은 관찰 데이터로부터 인과 추론의 신뢰성을 향상시키는 능력 덕분에 인기를 얻었습니다. 하지만 암 분야에서 표적 시험의 현재 사용 현황, 잠재적 도전과제 및 통찰력에 관한 지식은 부족합니다. PubMed와 Embase에서 체계적인 검토를 통해 암 분야의 총 90개의 TTE 연구가 확인되었습니다. 암 치료 분야의 54개 적용 중 등록 데이터베이스(44.4%)와 전체 생존율(OS, 63.0%)이 각각 주요 데이터 소스 및 주요 종결점으로 주로 활용되었습니다. 포함된 TTE 사례 중 약 30건(55.6%)은 불멸 시간 편향과 관련이 있었고, 21건(38.9%)은 기존 사용자 편향과 관련이 있었습니다. 기존 무작위 대조 시험(RCT) 결과를 보정하려는 13개 연구의 21개 시험 중 42.9%만이 통계적 일치와 추정치 일치를 모두 충족했습니다. 목적에 맞는 데이터 소스의 가용성과 결과 일치에 대한 불확실성이 암 분야 TTE의 양과 질을 제한하는 주요 장애물이었습니다. 특별 프로젝트 시작을 통한 규제 승인 촉진이 TTE를 이용한 실제 데이터(RWD)의 확대 적용에 중요한 역할을 할 수 있습니다. 지역 또는 국가 수준의 전자 의료 기록 통합, 보험 청구 데이터베이스 연계, 적격성 기준 현대화, OS를 주요 종결점으로 사용, 기타 모범 사례와 같은 잠재적 해결책이 암 분야 TTE의 실행 가능성과 품질 향상을 위해 권장되었습니다.

키워드

표적 시험 에뮬레이션 (TTE); 암; 편향; 실제 데이터베이스

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