Drug-safety service opens channels between industry and patient	April 2009

Startup times for Phase IV post-marketing studies typically take several months, but, according to one drug-safety visionary, going straight to the patients during that process can help cut down those times significantly. This type of patient access is one benefit pharmaceutical researchers might find from iGuard, a unique resource intended to allow patients to track their medication use.

iGuard (iguard.org), founded by Dr. Hugo Stephenson, a 15-year veteran in medicine, drug development, and drug safety, is a free and secure source of information for registered users who want to get informed, stay informed, and share feedback about the drugs they are taking. Launched in 2007 as a startup venture funded by contract research organization Quintiles Transnational, iGuard has received critical support from patient advocacy groups concerned by the large number of patients affected by serious, preventable adverse-drug interactions.

The company tracks about a quarter of a million patients who may be interested in hearing about research opportunities. For pharmaceutical developers, using iGuard gives them the advantage of going to the patients directly, thus accelerating startup time for observational studies. Dr. Stephenson, also the president of iGuard, says that using this service can cut six to 12 months off this process and as much as 75% off the cost of the traditional registry or observational outcome study.

iGuard may offer other benefits for drug developers as well. Rather than selling its data or using advertising, iGuard raises money by conducting surveys among its members. Pooled results from the surveys allow companies to identify ways to improve drug research and development, as well as learn what patient attitudes are toward therapies already on the market.

“Our objective is to provide medication monitoring services for as many Americans as possible, and in return, because it is a free service and is advertising as a free service, we are building the pool of patients available for research purposes,” Dr. Stephenson says.

Drug companies can go to iGuard with survey questions, which the service then passes on to the patients. Alternatively, companies can tell iGuard they want to follow certain patients for a period of time for prospective surveys. When iGuard receives the survey information, the service returns the data to the client in the requested format, whether it be an Excel or database format. Patients must first consent to participating in the surveys and are then compensated for their time.

“We feel very strongly that connecting real patients in the real world with drug researchers will allow us to learn about medicines much faster,” Dr. Stephenson says. “And in the end, isn’t that what we all want?”

iGuard has recently expanded its database through a partnership with Kerr Drugs, a leading pharmaceutical chain in North Carolina. The collaboration makes iGuard’s program available to Kerr Drug customers once they register on the company’s Website. Patients receive a real-time, personalized safety report that checks medications for potential side effects, treatment duplication, drug-drug interactions, and drug-disease interactions. Kerr Drug (kerrdrug.com) is the only retail pharmacy to provide its customers with the iGuard.org service.

iGuard plans on expanding its service to other pharmacies, mostly community and regional-based pharmacies. It also has some larger scale alliances in the works with hospital networks and potential insurance partners.

“Patients want greater communication from industry and regulators, and being able to provide that in a structured way helps build relationships with patients,” Dr. Stephenson says. “And that’s what we’ve been doing.”