In an unusual move for a contract research organization (CRO), Research Triangle Park, N.C.-based Quintiles has created a new service specifically for consumers of prescription drugs. The free service is called iGuard, a drug risk monitoring and personalized safety alert online site, and it’s a significant step toward patient-directed research.
Using secure methods through iGuard, patients anonymously provide demographic, disease treatment and medical history information to the site, along with contact information. If there is an issue with a consumer drug, such as a change in its prescription label, a side effect warning, or other warnings from the manufacturer or a medical journal, the system sends patients a form to take to their doctors.
And the site offers patients a simpler way to determine a drug’s general risk. The system uses a series of alert levels, such as ‘Low Risk,’ ‘Guarded,’ or ‘High Risk’ so patients know when to seek more information or ask a doctor more questions. iGuard can also poll the patients online for the occurrence of adverse events or for other useful information.
Where does all that patient data go? Quintiles is banking on sponsors seeing the raw information as a valuable post-approval data windfall, and the CRO believes it can sell the data to clients as a unique service offering.
In the U.S., doctors can voluntarily submit safety monitoring data to the Food and Drug Administration (FDA) through a program known as MedWatch. But according to Quintiles, not many of them do. In addition, patients do not often report adverse events to their physicians.
According to the president of the program, Hugo Stephenson, M.D., phase IV research and post-approval safety studies have been costly and time consuming, and the trials often deliver inadequate data...
“For every 100 doctors we would reach out to, we’d be lucky to get five doctors who actually came back to us to say that they would participate. And of the four or five doctors who actually said that they were interested, we would be lucky if one of those doctors actually recruited a single patient in those programs,” said Stephenson.
And fewer than half of the doctors who enrolled patients were following their progress after 12 months. Stephenson stated that those figures were consistent regardless of which sponsor initiated the study, the protocol or the therapeutic area.
“So sponsors were paying a lot of money and getting data that was really not valuable to anybody. And the spontaneous adverse event reporting system is equally bad,” Stephenson said.
The hope is that post-approval data taken directly from patients through iGuard could help reduce the number of trials sponsors need to conduct.
Stephenson’s team polled scores of patients to better understand their feelings toward the level of drug safety information in general. What they found was that patients just weren’t being kept informed about the medications they were taking.
“A quote that we got from one patient really set us passionately on this path was: ‘I get a note from my car company when there is something that needs to be reviewed with my vehicle. But no one calls me about problems with my drugs. We learn about those problems in the newspaper.’ So that is the challenge we face today,” revealed Stephenson.