Nature Medicine | Spoonful of Medicine

FDA approval signals more ‘homework’ on the horizon in trials

A growing number of people use technology to share the minutiae of their lives with others, detailing everything from the calories they consume, to the distance they run, to their point in the menstrual cycle. And clinical researchers are increasingly trying to harness this compulsion to divulge biometric data online. Now, with a 7 June go-ahead from the US Food and Drug Administration (FDA) for the country’s first completely at-home trial of a drug, the trend has come to the fore.

In a proof-of-concept study, a group from the University of California–San Francisco and New York–based Pfizer will trod through a trial of the company’s drug for overactive bladder, Detrol (tolterodine). The drug received approval for this indication in 1998; as such, the trial is simply to see whether a home-based trial can work. Participants will be recruited online and, with the exception of blood tests bookending the trial period performed by a visiting nurse, the participants are on their own. They will receive their pills in the mail and log their bladder activity through a mobile phone app.

Craig Lipset, Pfizer’s head of clinical innovation, came up with the concept for the trial a few years back and, surprisingly, ran into relatively little trouble getting it off the ground. The meeting with the FDA was packed with representatives from both the agency and Pfizer, and he says that the FDA “took the attitude of, ‘This is a really unique opportunity; let’s all learn and evaluate as much as we can.’"

(Click here to continue reading.)

Comments

There are currently no comments.