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Use of extrapolation common in FDA new drug approvals

Extraporation from basic experimental data to benefits of the U.S. Food and Drug Administration (FDA) has become commonplace, according to a study published online April 19 in JAMA Network Open.

Daniel Feldman, MPH, from Brigham and Women’s Hospital in Boston, and colleagues reviewed the prevalence of the disease. extrapolation of clinical characteristics beyond critical clinical data to final approved indications. The study includes 105 FDA approved drugs from 2015 to 2017.

The researchers found that 23 extrapolations examined the number of characteristics from clinical trials to the accepted markers found in 21 drugs (20 percent) in total. It was most likely to exclude experimental findings occurring in patients with severe disease (14 drugs), then differences in disease type (six drugs) and use of combination drugs (three drugs).

“The findings of this study suggest that the release of sensitive test data to FDA-approved indicators is common,” the authors wrote. “Although events can be used in rational clinical trials, they can limit the number of such symptoms to specific decisions; these findings suggest a high need for postoperative care to determine whether new security issues arise, or the impact is different from expectations when these drugs. are used in the world’s largest population. ”


Blacks have not yet been offered in trials for new drug approval


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