The world’s largest pharmaceutical company is conducting a drug trial that allows patients to participate from their homes... using phones and computers, saving them a trip to the clinic.
If this study – the first all-electronic, home-based method to receive approval from the Food and Drug Administration – works, it could seriously drive down the costs of bringing new drugs to market.
Pfizer plans to compare the results of this trial with those obtained from a more traditional trial of the same FDA-approved drug – Detrol, for overactive bladders.
That previous study, which was conducted in 2007 and involved 600 patients, compared Detrol to a placebo over 4 months.
Pfizer is currently recruiting for this new 16-week take-home study – dubbed Remote – through online ads that direct to the study website.
- Lab supplies will be sent to the participant’s home so blood can be drawn at a local clinic or during a home visit.
- Then they’ll be sent medication and a smartphone with an app to track overactive-bladder symptoms.
- Patients must complete periodic assessments on a website.
Earlier this year, Pfizer announced that it plans to slash research and development spending by billions of dollars. This electronic approach hopes to lower costs by making it easier to enlist patients into a trial.
Recruiting patients through sometimes dozens of study sites is one of the most expensive parts of clinical research; the cost of bringing a new product to market is estimated at $1 billion, with much of that related to trials.
Rather than use the several sites employed in most trials, this particular study is overseen by a single group of doctors at the University of California, San Francisco.
"This frees us from bricks-and-mortar sites," says UCSF’s Steven Cummings, co-founder of Mytrus, which developed the technology used in the Detrol study.
The method could also complement current clinical-trial infrastructure, particularly for experimental drugs that aren't on the market yet.
Developers have already been using elements in this trial, such as electronic patient diaries, and this electronic trial could provide a glimpse of what the future of drug development might look like.
Via Wall Street Journal.
Image by dharder via morgueFile
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