When it comes to drug safety, some people believe the end is nigh. But maybe it’s somewhere in the middle. And maybe technology can help.

That’s the message from Cynthia Verst, senior VP of the i3 Innovus late phase business. She says the contract research organization is seeing earlier requests for post-marketing study assistance than it has in the past. Clients “are getting us involved well before pivotal Phase III data are submitted,” Verst says. “Late phase is a very, very hot topic and a very wide open market place with regard to the opportunities.”

The company is a division of Ingenix, which is in turn part of United Health Group, one of the largest HMOs with $75 billion in annual revenues.

Hot Market

The Innovus division of the i3 parent company is dedicated to outcomes research, with a newly dedicated group of economists, epidemiologists and health outcomes researchers helping on industry-sponsored clinical trials. In some cases, post-marketing projects are being planned during the year that the FDA typically takes to evaluate a submission. In effect, she says, sponsors are trying to get ahead of the curve and anticipate regulatory requests for additional post-approval data.

In some cases, i3 Innovus is able to recommend and recruit virtual trials. That’s thanks to the 550,000 prescribing physicians and 55 million patients in the United Health database. It’s worth noting that that data is of de-identified patients.

A case in point. One customer wanted to compare two statins. Because the expected difference between the two drugs was not large, the client wanted approximately 150,000 patients, and it wanted them yesterday. On a limited budget. Verst reports the company was able to use its databases to find the patients. “This would have been a very expensive trial, on the order of magnitude of tens of millions of dollars,” she says. “We could do it in a manner that wasn’t going to be so taxing on the site or patient. We didn’t have to pay the doctor a large grant.”

Silicon Recruitment

The initial round of data acquisition is subject to the approval of an institutional review board, she says. “We can retrieve the data retrospectively,” Verst says. “It does not need to be collected from the site or the patient. We knew exactly who the doctors were. We could identify the patients within those practices.”

In some cases, the company contacts the patients directly, without troubling the physician. In some cases, even nurses are not needed to interview the patients; a computer can conduct the interviews with patients.

The topic of electronic health records or electronic medical records in clinical trials is a big one, and one that seems to be on a not-so-distant horizon. Verst says such systems can make finding deidentified patients easier. “We can comfortably conduct these programs in a cost-effective modality,” she says. “It’s an in silico approach. In some instances, we can conduct a study completely within the database, either retrospectively or prospectively and never have to touch a patient.”

Linking Billing, Rx

The database has a level of granular detail about patients that not all competitors can match,  says Verst. “Unlike the IMS claims data, we can connect our data to ICD-9 codes. We know why a patient was receiving the medication. We also have urgent care center information.”

In other cases, when there is additional time, the i3 Innovus team will work with the prescribing physicians, who will contact the patients and ask that they return to the office for additional lab work and other consultations.