In an online recruitment ad for its latest trial of the overactive bladder drug Detrol, Pfizer invites patients to “participate in the privacy and comfort of your home!” To the casual observer, the ad is hardly groundbreaking, but it’s a first in the world of clinical trials.
Pfizer plans to carry out the entire study—from recruitment to followup—using only mobile and Web-based tools. With the FDA’s approval, the drug maker will attempt to replicate the results of a 600-person trial conducted in 2007 using conventional methods to compare Detrol with a placebo.
If it succeeds, the virtual trial, dubbed REMOTE (Research on Electronic Monitoring of Overactive Bladder Treatment Experience), could provide a patient-centered, cost-effective way to bring new drugs to market. Except for a blood test performed at a local clinic, REMOTE is designed to take place 100% electronically, engaging patients through multiple channels in a way traditional trials do not.
Patients who respond to Pfizer’s online recruitment ads are directed to a Web site explaining the study, where they participate in a screening to determine their eligibility. Enrolled patients will receive all study materials—including blinded study medication, a mobile app to track and report symptoms to investigators, and their own personal clinical data—either through the mail or online.
“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, MD, who announced the trial June 7, 2011, at the National Library of Medicine Clinical Trials Conference in Bethesda, Maryland.
Cutting costs and speeding the trial process are major benefits of the virtual approach, but reaching patients is also critical, Dr. Lewis-Hall added. “Putting research within reach of more diverse populations has the potential to advance medical progress and lead to better outcomes for more patients,” she said.