In June 2011, Pfizer announced the REMOTE trial, the first "virtual" randomized clinical trial under an IND to assess the safety and efficacy of Pfizer's Detrol LA, a treatment for overactive bladder. The study is specifically designed to test the methodology of the virtual trial concept, to determine if it can replicate the results of the previously completed Phase IV Detrol LA trial. The trial is called REMOTE for Research on Electronic Monitoring of OAB Treatment Experience. In the past three issues of Applied Clinical Trials, we have written on the technology vendors involved in the trial--Mytrus, Exco InTouch, and Greenphire. Mytrus serves as the single coordinating center for patients, recruitment, the principal investigator, sub-investigator, and the coordinators; Exco InTouch provides the eDiary technology; and Greenphire is providing subject payments. Technology applications The remaining technology piece comes from Perceptive Informatics, which according to Bill Byrom, Senior Director, Product Strategy at Perceptive Informatics, is providing the core clinical trial technology applications of Randomization and Trial Supply Management (RTSM) and EDC via IVRS. Perceptive's role is to support the trial and is working closely with Pfizer to serve as the central integration point to join all third party technology applications to present a seamless eClinical solution.
Applied Clinical Trials, Nov 1, 2011