Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
Pfizer has announced the first FDA-approved clinical drug trial involving all-electronic home-based reporting, according to a report in the Wall Street Journal. The drug being "tested", Detrol, is intended for use by patients with overactive bladders. However, the real purpose of the study, according to Pfizer, is to compare the mobile reporting of trial data to traditional methods of drug testing. The drug had previously been tested against a placebo during a four month 600 patient trial in 2007.
Trial participants will not be required to go to a testing facility at any point during the study. Participants will not be required to live near a test site either. Pfizer plans to recruit them via online ads. Pfizer plans to mail participants the medication and them have them use diaries on their smartphones to track symptoms, conduct blood tests at home, and fill out periodic assessments online.
"Modernization of clinical trials is a key initiative of FDA," Janet Woodcock, MD, director, Center for Drug Evaluation and Research at FDA stated in a release. "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."
So, why explore this "virtual" clinical drug trial? Largely: Costs. It's no secret that the cost of researching drugs is climbing, while a wave of drugs patents are set to sunset in the coming years. Drug companies are looking for ways to cut costs and the costs of bringing a new drug to market is about $1 billion on average, according to the Wall Street Journal report. Most of that cost is attributed to the clinical trials.
It will be interesting to see how different the results of this virtual trial turn out to be from the original -- it may be even more interesting to hear the costs of the mobile-enabled trial vs. the original.
More on the mobile-enabled trial in this WSJ report