新型冠状病毒肺炎疫情期间抗肿瘤药物临床试验的管理

2019年12月以来,新型冠状病毒肺炎的病例数不断扩增,随着疫情的蔓延,抗肿瘤药物临床试验面临着巨大的挑战,肿瘤患者由于疾病本身、手术、放化疗等治疗处于特殊免疫状态下,是新型冠状病毒的易感人群,较正常人群更易罹患感染新型冠状病毒。为此,本文将从新型冠状病毒肺炎疫情下抗肿瘤药物临床试验受试者的特殊性、临床试验的管理、存在的问题及应对措施等方面阐述,期待通过优化流程、合理安排,在确保受试者安全的前提下保证临床试验的顺利进行。

Management of clinical trials for anticancer drug during the corona virus disease 2019

Since December 2019,the number of corona virus disease 2019 cases has continued to increase.With the spread of the epidemic,clinical trials of anticancer drugs are facing great challenge.Cancer patients are suffering from the tumor itself,surgery,radiotherapy and chemotherapy under special immune status,they are susceptible to the new coronavirus,and are more susceptible to infection with the coronavirus than the normal population.Therefore,this article will elaborate on the particularity of subjects in clinical trials of anticancer drugs in the context of the corona virus disease 2019,management of clinical trials,existing problems and countermeasures to expect optimizing processes and reasonable arrangements,and to ensure the safety of patients so that the smooth progress of the clinical trial is guaranteed.