Clinical drug trials enter electronic world

Pfizer is conducting what it calls the first-ever all-electronic drug trial, in which patients at home will report outcomes to the company through the Internet. The testing patients’ individual physicians will not be hired as investigators. Instead, the patients will report and manage their trial activities to a central physician investigator who will oversee the entire process. The drug being tested, Detrol LA (tolterodine), prescribed for overactive bladder, already has completed a Phase IV, post-market clinical trial and has been on the market for 10 years. But Pfizer wants to repeat the testing in a Web-based, patient-centered model to see if it replicates the results of earlier trials, and whether this process could be used for future trials — perhaps changing the clinical drug trial process and potentially saving drug companies a lot of money. The Food and Drug Administration has approved Pfizer’s electronic study. Pfizer said it hopes to enroll 600 patients from 10 states who will receive the blinded study medication — and a smartphone — in the mail. The patients will manage all their trial activities on their own using Web-based tools. Results will be reported directly to trial investigators through the Internet. Patients will receive trial data and results back from investigators and have the ability to record their data in their own personal health records.

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