As Pfizer ($PFE) looks to tighten its belt on R&D spending, the drug giant has revealed plans to begin an FDA-approved clinical trial for an overactive bladder pill that enables patients to participate without having to leave their homes, the Wall Street Journal reports.
The study is being called the first all-electronic, home-based clinical trial to gain an OK from U.S. regulators because patients can report their progress via smartphones and their computers rather than going to clinics. The plan is to use online advertisements to recruit study patients, enable them to get initial blood work in their homes, and mail them supplies of the study drug (Detrol) directly. This means they won't have to travel to clinics to get checkups, one of several factors that will reduce the infrastructure that would normally be needed to support a conventional clinical trial.
Pharmas have been targeting the design and operation of clinical trials to make drug development more efficient and less of a drain on their bottom lines. Recruiting patients for such studies is often quite expensive and time-consuming. Pfizer, which was the world's largest research spender last year in pharma, with an R&D budget of $9.4 billion, has a lot to gain from making its trials run more efficiently. And the company, which plans to announce the study today at a National Library of Medicine clinical trials conference, is interested in seeing whether elements of the electronic study could be used in trials for some of its experimental drugs. Detrol has been approved for over a decade.
"This frees us from bricks-and-mortar sites," Steven Cummings, an emeritus professor of medicine at the University of California, San Francisco, told the WSJ. A group at UCSF will oversee Pfizer's electronic study, which will be compared with results from a conventional study of Detrol done in 2007 that involved 600 patients. Cummings also co-founded Mytrus, a San Francisco firm that is behind the technology for the electronic study.
No doubt industry will be watching closely to see whether the electronic trial succeeds. Developers are already using elements in this trial, such as electronic patient diaries. But Pfizer's electronic trial could provide a glimpse of what the future of drug development might look like.
- read the report in the Wall Street Journal