抗肿瘤药物临床试验中的受试者管理

Subjects management in anti-tumor drugs clinical trials

通过分析肿瘤临床试验知情同意过程、随访安排、访视接待及生存随访过程中受试者管理的问题和方法,探讨研究者、研究护士、临床研究协调员、受试者本人及试验设计本身对受试者管理的影响和作用,为后续肿瘤临床试验开展过程中受试者的管理提供参考。

In this paper, authors analyze problems and methods of tumor clinical trials in the informed consent process, arrangement and follow-up visit reception and the survival follow-up management. Influences of investigators, clinical research nurses, clinical research coordinators, subjects and research designs on the management of tumor clinical trial subjects are discussed. And some opinions and suggestions are provided.