电子数据捕获系统在新药临床试验中的影响

Effect of electronic data capture system in new drug clinical trials

随着计算机和网络技术的发展,电子数据捕获(EDC)系统在新药临床试验中的优势不断显现,并受到新药临床试验研究机构的青睐。EDC凭借其技术上的优势,简化了传统以纸张病例报告表为载体的临床试验流程,克服了其数据录入和数据清理滞后的缺点;研究者、临床监查员、数据管理人员等在应用EDC系统情况下的角色和职责分工也发生了相应的改变;同时,其为新的试验设计和统计方法,如适应性设计方法的应用实施提供的有利的平台。

With the developments of comput- er and net technology, the superiorities of Elec- tronic Data Capture（EDC） system are increasing in clinical trials and it is getting popularity in tri- al participants. With the help of the excellent technologies, EDC simplifies the trial process of traditional paper CRFs and overcomes the lags of data entry and data cleaning. The roles and re- sponsibilities of sponsors, monitors and data managers change. Meanwhile, EDC makes it feasible to apply new trial designs and statistical methods, such as, adaptive design.