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Sponsors Getting 'Proactive' About Phase IV Studies

Deborah Borfitz

For a multitude of reasons, it's good idea for sponsor companies to spend more energy on so-called "Phase IV" post-marketing studies. A maturing drug pipeline is at risk of generic erosion unless new indications are found. Medicare and private health plans are demanding more real-world data as a condition of coverage for specific subpopulations. High-profile recalls have drawn unflattering public attention to blockbuster products.

Oh, and the FDA is a bit more interested in seeing companies follow through on their promise to do Phase IV studies as a condition of marketing approval. Even the average consumer probably now knows that adverse events aren't fully discoverable until a product is mass marketed.

It is no surprise then, that -- based on annual spending levels -- Phase IV trials are the fastest-growing category of clinical research. In 2007, development spending on Phase IIIb and IV trials is projected to be over $5 billion - nearly four times the 2000 figure, according to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development. The number of participants in Phase IV programs also skyrocketed to a median of 920 in the 1990s, up from 123 a decade earlier.

The chief goal of Phase IV studies is to satisfy regulatory demands or, sometimes more important, to increase a product's profit potential. Overall growth in ethical pharmaceutical sales has been sliding for more than a decade, reports Getz.

"We're seeing companies take a proactive approach to post-marketing data acquisition in the form of [disease/patient] registries," remarks Jeff Williams, CEO of Clinipace in Research Triangle Park, N.C. The primary aim is to collect "new data for new indications...and [off-label] applications." Many new companies are popping up that do nothing but search for alternative indications for existing products.

"Previously, post-approval studies were primarily funded either through the NIH [National Institutes of Health] or as investigator-initiated trials funded by industry, but now we see more sponsor-initiated phase studies and registries," says Richard Gliklich, president and CEO of Cambridge, Mass.-based Outcome. The NIH has also been shifting more attention to Phase IV trials, however, as a search of its Web site attests.

Interest in registries is driven by high-profile recalls, such as the Vioxx incident. "Post-marketing surveillance is primarily dependent on the voluntary reporting of adverse events by providers -- meaning they need to not only recognize the event, but know that it's not on the label -- and that doesn't happen with great predictability or with a denominator for determining rates [of particular adverse events]," says Gliklich. The New England Journal of Medicine never succeeded in its push to follow the first 20,000 recipients of every released product. But the FDA has moved towards recommending or requiring "risk minimization action plan" that has spurred tremendous interest in registries both here and abroad.

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