以患者为核心的抗肿瘤药物临床研发的审评考虑

Considerations for the review of patient-focused development of antitumor drugs

药物上市的根本目的是解决患者的需求。药物研发应以患者需求为核心,以临床价值为导向,已成为普遍共识。对于肿瘤患者,临床治疗需求急迫,因此抗肿瘤药物研发更应着眼于对患者需求的回应,将以患者为核心的研发理念贯穿于研发始终。在抗肿瘤药物确立研发立题之初,应积极收集、倾听患者的声音;在临床试验设计中,应体现对患者获益保障的设计理念;而在临床试验的开展过程中,也可以采取和融入更多体现对受试者关怀的新型临床试验方式,最终实现抗肿瘤药物的科学合理研发,实现肿瘤患者获益的最大化。

The fundamental purpose of drug marketing is to meet the needs of patients.Patient-focused drug development and clinical value oriented research have become common understanding.For cancer patients,the need for clinical treatment is urgent.Antitumor drug development should focus on the response to the needs of patients.Patient-focused research and development should be implemented throughout the research and development process.At the beginning of the development of antitumor drugs,the voices of patients should be actively collected.The clinical trial design and the concept of patient benefit protection should be reflected.In the process of clinical trial,new clinical trial methods that reflect the care of the subjects can be adopted and integrated,so as to realize the scientific and reasonable development of anti-tumor drugs,and maximize the benefits of cancer patients.