McClellan plays NCI card again

Centers for Medicare & Medicaid Services Administrator Mark McClellan has taken a page from his FDA experience, negotiating a collaboration with NIH's National Cancer Institute that is designed to generate real-world data that can guide both treatment and coverage decisions.

Soon after he was confirmed as FDA commissioner, McClellan started talking with NCI Director Andrew von Eschenback about ways for the two agencies to collaborate. The result has been a much closer involvement of NCI with FDA's review of cancer applications, especially with the design of Phase IV trials to support accelerated approvals (see BioCentury, May 19, 2003 & June 23, 2003). ...