This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citing articles on HighWire  • Citing articles on Web of Science (4)  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Topic Collections  • Health Policy  • Drug Therapy  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

Confirmatory Phase 4 Studies on New Drugs Languish

Mike Mitka

JAMA. 2003;289:3227-3229.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The accelerated approval regulations of the US Food and Drug Administration (FDA) allow pharmaceutical manufacturers to offer patients treatment for life-threatening diseases. This may occur when early evidence suggests that the agent is likely to improve survival or reduce symptoms, before confirmatory studies show whether the compounds are fully safe and efficacious.

However, while this concept is embraced by many clinicians and patients, recent evidence suggests that its execution leaves much to be desired.

CONFIRMATORY TRIALS

When granting accelerated approval of a new drug, the FDA still requires the product's sponsor to complete confirmatory studies. But critics charge that this arrangement creates an environment that makes completion of such phase 4 trials unlikely. They say such trials have trouble enrolling patients in a timely manner, partly because many patients worry about being randomized into a control group and not getting a new drug they believe may be better . . . [Full Text of this Article]

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Beyond Fast Track for Drug Approvals
Roberts and Chabner
NEJM 2004;351:501-505.
FULL TEXT