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.

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