EDC Essential in Adaptive Clinical Trials
Electronic data capture (EDC) is essential for any sponsor considering conducting an adaptive clinical trial, according to experts speaking at the Drug Information Association’s 43rd Annual Meeting.
Adaptive trials are those in which certain parameters can be altered using interim data while the trial is ongoing. For example, dosage levels of the investigational drug that turn out to be either unsafe or ineffective can be dropped, or the entire study can be halted due to “futility.” Adaptive trials, which must be designed as such in advance and detailed in the protocol, are also called “seamless” because the traditional distinctions between Phase I, II and III may not hold.
To gather the information for the data-monitoring committee that an adaptive trial requires, paper case report forms are too slow; instead, EDC and eclinical systems are necessary, Jerald Schindler, vice president of Biostatistics and Research Division Sciences at Merck Research Laboratories, said.
Using EDC is the way to ensure access to real-time patient results, Schindler said. Adaptive trials require online review using an eclinical system, the software for which must be prepared before the trial starts, he added.