Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported / 中华肿瘤杂志

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.

Application and thinking of cohort study in clinical research of acupuncture and moxibustion / 中国针灸

Cohort study has been greatly considered and widely used in clinical research of traditional Chinese medicine in China, but it is seldom applied in the field of acupuncture and moxibustion. This paper introduces the development background, basic concepts, advantages and limitations of cohort study, analyzes the existing problems in the evaluation of acupuncture and moxibustion curative effect and development status of cohort study in the cycle of acupuncture and moxibustion, explores the feasibility and value of such method in clinical research of acupuncture and moxibustion and proposes the methodological suggestions on rigorous design, control of selective bias, control of cohort migration and reduction of loss to follow