Thought Leader: Q&A with Hugo Stephenson

The market is asking for more post-marketing research. How can companies handle that demand? Hugo Stephenson, MD, president of Quintiles' Strategic Research Services, offers insight into the struggles pharma faces, and the solutions they're finding, to financing post-approval clinical trials.

Pharm Exec: Who conducts strategic research?

Stephenson: Historically, the Phase IIIb and IV market was split evenly among big contract research organizations (CROs), the small "mom and pop" CROs, and academic research organizations.

How is that changing?

The small CROs are cheap and nimble. But you wouldn't want them to conduct a study that had a chance of being audited. Before medical registries, these studies were under the radar. Now, there's full visibility, and all studies in the post-Vioxx era run the risk of being audited, or worse still, reviewed by lawyers as part of a court case.

FDA audited three studies in the last quarter, and one has been reviewed by an external legal team, compared with the previous 12 months when zero of that was happening. In response, companies have shifted dollars from small CROs toward academic groups and big CROs.

How are companies handling the increased cost?

They're not. Instead of outsourcing on a trial-by-trial basis—the most inefficient way to use CROs—they're looking at more creative ways to operationalize these studies.

We've had five companies come to us with their 2006 Phase IIIb/IV pipeline and say, "These are the studies we want to do, and this is our budget. What can you do to back in those studies into that budget?" With that approach, companies have saved 30 percent or more over the standard trial-by-trial-based approach.

Are companies willing to change how they do research?

Companies have their back to the wall. That don't have the budget, but are being forced, either though commitments or public concern, to do more large, active surveillance research. They are desperate to find ways to do this.

What are promising research alternatives?

Going through doctors is not a cost-and data-quality effective way of conducting simple studies and postmarketing surveillance. A pediatrician who sees 50 patients a day is in the business of treating those patients. Even if they wanted to, they're not geared to conduct clinical trials. For every 100 sites that I go to, 15 will respond with a level of interest. For those 15, only two or three will actually recruit any patients at all.

Companies may want to go to patients, rather than doctors, when the primary outcome measures are absolute—like patient-reported results such as days missed from school. On those studies, physicians only need to confirm the diagnosis and input a little clinical information at the start of the trial.

What are you finding?

When you go directly to patients, uptake is in excess of 65-70 percent. If I send a clinic 10 forms to fill out for 10 patients in a trial, I'm lucky if I get two back. If I sent those forms to patients and say, "When you visit the doctor, make sure he fills those in," I'll get seven or eight back. Because it's about their health, patients are happy to put in the effort, especially if they receive something that benefits them, like a report, in return.

Will companies adopt this method?

We're conducting several pilots. It has gained interest particularly in the United Kingdom—where there's more bureaucracy around running trials through individual treatment centers.