摘要
Abstract
The advancement of artificial intelligence and big data has accelerated the exploration of decentralized clinical trials(DCTs),and their future complementary relationship with traditional clinical trial models represents an inevitable trend.Given the greater complexity of preliminary research and protocol design in oncology drug clinical trials,the implementation of"decentralization"requires all stakeholders to clarify the responsibilities and authorities,enhance communication and collaboration,conduct comprehensive training,and progressively promote the integration and sharing of medical resources,thereby facilitating the establishment of a new quality and risk management framework.Concurrently,institutional review board should focus on reviewing and evaluating the scientificity,feasibility,and research risk controllability of DCT project protocol designs.It should also prioritize the implementation of informed consent norms,the management of safety event reporting and continuing review,and the protection of participants'personal information and privacy.By adopting corresponding ethical review procedures,it emphasizes improving the risk identification and addressing capabilities of institutional review board members regarding the review projects,guiding researchers to adhere to DCT regulations.This aims to genuinely implement the"value-oriented,patient-centered"philosophy,thereby promoting the standardized and efficient conduct of DCTs.关键词
去中心化临床试验/以患者为中心/伦理审查/数字健康技术Key words
decentralized clinical trial/patient-centered/ethical review/digital health technology分类
医药卫生
