Pfizer is starting enrollment of its first ever investigational drug trial with remote patient participation. The trial, aptly named Research on Electronic Monitoring of OAB Treatment Experience (REMOTE), is a study to assess the safety and efficacy of Detrol LA (tolterodine tartrate), a treatment for overactive bladder. The main goal is to determine whether the results of the pilot REMOTE “virtual trial” can replicate the results of a previously completed conventional phase IV Detrol LA trial.
From the press release:
The randomized clinical trial 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 FDA, uses mobile phone and web-based technology to collect necessary data for the trial without clinic visits.
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.
Investigators in the REMOTE trial plan to enroll about 600 patients from about 10 states across the United States. Enrolled patients will participate in the study screening process through the Internet, actively manage their own trial activity and report results directly to a trial investigator who keeps close oversight of patient eligibility and safety. As a result, researchers expect to save time and obtain better quality, more reliable data through increased patient compliance, lower withdrawal rates and real-time data collection.
Pfizer has reviewed the study approach with the FDA and two institutional review boards have approved the study. Physicians will carefully monitor patient data and patient safety throughout the trial. Patients will be able to interact with study physicians remotely 24 hours a day.
Study participants are being recruited through internet advertisements and directed to the study’s website, which explains the study and allows enrollment. Real-life contact will still be required for blood to be drawn and the occasional physical exam. If all goes well, Pfizer and the FDA plan to use these tools in more clinical studies. Mytrus, the company supporting the online system, already mentions upcoming trials for osteoarthritis, binge eating, COPD, diabetes, sleep disorders and informed consent validation on its website.
Trial homepage: Mytrus…
More about Mytrus: ClinPage: No Site? No PI? No Problem…