A Clinical Drug Trial Via Phone, Computer

Pfizer is conducting a drug trial in which patients participate from their homes using computers and smartphones rather than visiting a clinic.

The company plans to compare the results to those obtained from a previous, traditional trial of the same drug. The study involves the company's overactive-bladder drug Detrol. If successful, the methods used in the study might eventually be used to help drive down the high cost of bringing new medicines to market. The Food and Drug Administration recently signed off on Pfizer's study, which is believed to be the first all-electronic, home-based study of a drug to receive agency approval. Study participants are being recruited through Internet advertisements and directed to the study's website, which explains the study and allows enrollment. Patients who enroll in the study will be required to have blood drawn at a local clinic or during a home visit. Medications will be mailed to participants, something that's rarely, if ever done in clinical trials. Patients will keep diaries using a mobile phone that has an application specifically designed to track symptoms of overactive bladder. Patients will fill out assessments on a secure website four times throughout the study. Although a home-based, electronic approach won't work for all drugs in clinical trials, the company and the FDA are looking to see if the technology can be integrated into more studies to make it easier to recruit patients and allow them to participate in clinical research. Now, patients usually need to live near a study site to participate.