| Autor: |
Tang L; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Zhou M; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Xia L; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Hao RM; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Tong X; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Chen DM; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Song YY; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Zhao X; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Zhang H; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Hu WJ; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Zou LM; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Du Y; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Qi YL; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Chen XM; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China., Yang ZM; Center for Drug Evaluation, National Medical Products Administration of China, Beijing 100022, China. |
| Abstrakt: |
Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs. |
