Meeting the Challenges of Internet-based Clinical Trials.

In the mid to late 1980s, a tool called remote data entry was available which replaced double key data entry and paper case report forms (CRFs) at the clinical trial study site. When remote data entry was used, the drug sponsor would provide a portable computer to the investigational site. The coordinator would collect study-related patient data, and then enter the data directly into the computer via the specially designed user interface of data entry screens. The electronic data would then be monitored. After data cleanup, a floppy disk with the site's data would be sent to the sponsor via an overnight courier service. These tasks would occur periodically during the course of the clinical trial. More recently, Internet-based clinical trials (IBCTs) have been introduced. However, there are major challenges for companies who choose to implement IBCTs. Some clinical research professionals question the advantages of moving away from "tried-and-true" tools such as paper CRFs.