From Informed Consent through Database Lock: An Interactive Clinical Trial Conducted Using the Internet *

Abstract

This paper describes an interactive clinical trial that utilized the World Wide Web and Internet technologies throughout the conduct of the trial from informed consent through database lock and study closure. We believe this is the first development and administration of an interactive clinical trial that utilized the Internet for trial execution while complying with regulations for clinical trials conducted under an Investigational New Drug application.

A United States study of tadalafil, a phosphodiesterases inhibitor used as an oral treatment of erectile dysfunction, was chosen to implement the interactive clinical trial. The trial consisted of 83 enrolled patients who were randomly assigned to either tadalafil 20 mg or placebo for four weeks of treatment. The trial leveraged the Internet for the informed consent process, randomization, drug dispensing and accountability, safety monitoring, in-home data collection of patient-based efficacy measures, and database lock. The efficacy data resembled traditional tadalafil clinical trial data; the adverse events incidence, however, was lower than anticipated. In a post-study survey, 77% of patients with traditional clinical trial experience indicated that the interactive clinical trial was better than a traditional trial. The success of this interactive clinical trial represents a new direction for regulatory-compliant clinical research powered by the Internet.