“Virtual” clinical trials - a revolution in drug development

Pharma Company Pfizer, announced to conduct the first ever randomized clinical trial of a drug Detrol LA for the treatment of overactive bladder (OAB) that uses mobile phone and web-based technology to manage patients remotely rather than visiting a clinic.

Industry executives believe the study has far-reaching implications for improving the productivity of clinical trials in the future.

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.

"With the REMOTE virtual trial pilot, for the first time we can make it possible for patients to participate in clinical trials without having to visit physical sites," said Pfizer Executive Vice President and Chief Medical Officer Freda Lewis-Hall, M.D., who announced the new trial today during remarks at the National Library of Medicine (NLM) Clinical Trials Conference in Bethesda, MD. "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."

“Modernization of clinical trials is a key initiative of FDA. We commend Pfizer’s progress on the REMOTE pilot and encourage all manufacturers considering other novel ideas in advancing clinical trials to have prospective discussions with the Agency regarding trial design and oversight," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research at FDA. For more information about CTTI, visit www.trialstransformation.org.

"This virtual method enables scientists to conduct trials more efficiently. Additionally, as more people participate in trials conveniently from home, the results of trials may apply to a broader patient population," said Dr. Steven Cummings, M.D., Emeritus Professor of Medicine at the University of California San Francisco.

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.

Patients interested in participating can visit the trial site at http://oab.mytrus.com/home