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Half of New Drugs in the U.S. Have Comparative Efficacy Data

Availability of comparative data varies widely according to therapeutic area

WEDNESDAY, May 4 (HealthDay News) -- Approximately half of all new molecular entities (NMEs) recently approved in the United States contain comparative efficacy data in the U.S. Food and Drug Administration approval packages, according to a study published May 4 in the Journal of the American Medical Association.

Nikolas H. Goldberg, from Harvard Medical School in Boston, and colleagues quantified the availability of comparative efficacy data for 197 NMEs approved by the FDA from 2000 to 2010. They determined whether studies were head-to-head active controlled trials, and whether the results were available in the packaging. Data collected included approval indication, whether the NME was an orphan drug, if it had undergone priority review, and characteristics of the control groups (specific operator or standard care).

The investigators found that 100 NMEs had comparative efficacy data available at the time of market authorization. The proportion of NMEs with comparative data available increased to 70 percent when the 37 designated orphan NMEs and 17 NMEs approved for indications with no alternative treatments were removed from the analysis. Availability of comparative efficacy data varied widely by therapeutic area from 33 percent for NMEs of hormones and contraceptives to 89 percent for diabetes NMEs.

"We found that publicly available documents include results of at least one head-to-head trial with an approved alternative for approximately half of all newly approved NMEs," the authors write.

One of the study authors disclosed financial relationships with clinical research and scientific consultancy industries.

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