Patient Support in DCTs
Patient Support in DCTs Introduction Decentralized clinical trials (#DCT) are currently a much discussed approach to clinical trials. DCTs differ from ‘traditional’ trials in several ways: because patients are not required to visit a site as often, there is reduced reliance on the investigator and site personnel to serve as the hub of activity for […]
Review of eSource for Clinical Trials
Review of eSource for Clinical Trials Overview – source data Electronic data in support of new drug applications have been the standard for submittal to regulatory authorities – ever since computers were found to be reliable and their prevalence made them readily available. For much of that time, however, the source documents on which the […]
Decentralized Clinical Trials
In recent years, increasing attention has been paid to a method of clinical trial design that de-emphasized clinical site visits in lieu of relying on patients for generated and collecting more data themselves. Among the drivers for this change were to simplify trial design, allow patients to avoid some portion of site visits, involve patients […]