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As the Food and Drug Administration increasingly relies on just one key clinical trial or surrogate markers for approving certain medicines, a new study suggests that sufficient follow-up evidence demonstrating these drugs actually work varies substantially.

The study examined 117 novel drugs that were approved by the FDA between 2005 and 2012 for 123 indications on the basis of a single pivotal trial, which is intended to provide evidence that a drug works; pivotal trials that used surrogate markers to gauge whether a drug can work; or both approaches. The researchers then sifted through medical literature in search of follow-up, or post-approval, studies.

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