Electronic drug monitoring "cheaper than clinical trials"

Electronic monitoring of drugs and medical devices would be cheaper than post-authorization clinical trials and provide benefits for patients, regulators and drugmakers alike, according to a professor of medicine and business administration at Duke University, North Carolina, USA.

Kevin Schulman, who is also a qualified physician, argues in the North Carolina newspaper, the News & Observer, that "an active system to monitor products would be a big improvement." Prof Schulman contrasts the situation where people purchasing consumer goods, such as children's toys, are often asked to register the product by mail or via the Internet, with health care. He says: "new devices and medications offer tremendous promise to the aging population of the USA. However, with the increasing use of new technologies, it is remarkable how little we do as a society to monitor their safety and effectiveness. Currently, the Food and Drug Administration monitors the safety of marketed drugs and devices by receiving spontaneous reports from physicians and patients or through follow-on clinical trials of products that have entered the market."

Existing regulations mean that, although some hospitals maintain electronic registries for some products, so that manufacturers are notified, Prof Schulman notes that "the patient receives only a paper copy at discharge, if anything at all. A patient who has a problem with the device can't easily report this news in a way that would be helpful to the nation's surveillance system."