The Burrill Report


Pfizer says it is launching the first-ever randomized clinical trial under an investigational new drug application, allowing about 600 patients in ten states to use mobile phones and the web to participate regardless of location.

The pilot project, dubbed REMOTE, for Research on Electronic Monitoring of Overactive Bladder Treatment Experience, is sure to be watched closely watched by the U.S. Food and Drug Administration, which has its own initiatives to improve the quality and efficiency of clinical trials. The study will assess the safety and efficacy of Detrol LA, a treatment for overactive bladder. Pfizer hopes the results of the virtual trial will mirror results of a previously completed late-stage trial of the drug, thereby validating what the company sees as a “patient-centered” approach to clinical research.

“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials. Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients,” says Freda Lewis-Hall, an executive vice president and chief medical officer for Pfizer.

Clinical study patients typically have to register in person with researchers and often make doctor visits to receive trial medications and report on treatment effects. In the REMOTE trial, investigators will instead ship study medication to participant’s homes. Researchers will also be able to remotely manage the study and share clinical trial data and results with patients. Such flexibility offers not just efficiency, but the possibility of reaching a broader patient population, says Steven Cummings, Emeritus Professor of Medicine at the University of California San Francisco.

The digital infrastructure enabling Pfizer’s novel study will be provided by San Francisco-based Mytrus, a small startup that will help patients find trials that interest them, screen for patients meeting study criteria, and handle additional logistics. Upcoming trials listed on the company’s web site include studies of treatments for osteoarthritis, binge eating, chronic obstructive pulmonary disease, diabetes, and sleep disorders.

“This approach, if proven successful, holds considerable promise in speeding up clinical trials while improving their quality,” says Briggs Morrison, Pfizer’s senior vice president of worldwide medical excellence. “This program and similar programs that may follow could lead to an entirely new way for patients to participate in trials and contribute to biomedical research.”


June 10, 2011
http://www.burrillreport.com/article-pfizer_launches_electronically_tracked_trial.html