Pfizer is going to conduct the first-ever randomized clinical trial under an investigational new drug (IND) application that manages study participation entirely using electronic tools and allows patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project, initiated following review from the U.S. Food and Drug Administration (FDA), uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits.
The Research on Electronic
Monitoring of OAB Treatment Experience – REMOTE – is a U.S.-based Participatory
Patient-Centered (PPC) clinical trial designed to assess the safety and
efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive
bladder (OAB). Pfizer and its research partners hope to determine whether the
results of the pilot REMOTE “virtual trial” can replicate the results of a
previously completed Phase IV Detrol LA trial, and in this way begin to
validate virtual, patient-centered approaches to clinical research.
The
REMOTE trial is the first-ever randomized “virtual” clinical trial under an IND
application to secure patient consent online using video/multimedia and online
testing. Study investigators will ship all blinded study medication to patients
at home rather than dispensing it at a clinic visit. Researchers will manage
study conduct remotely, and share clinical trial data and results with
patients, enabling them to add them to their own personal health records
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