STAT+: Pharmalittle: FDA proposes more rigorous cancer drug trials for accelerated approval; insurers not covering obesity meds for kids
The FDA proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval.
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The U.S. Food and Drug Administration proposed cancer drug developers in most cases conduct more rigorous trials to seek accelerated approval for their candidates, Reuters tells us. The agency proposed that companies conduct randomized controlled trials in which patients receive either a therapy or another alternate treatment instead of trials that test the drug without a comparator, known as single-arm studies. The FDA suggested two approaches — one of conducting a randomized clinical trial before getting the accelerated nod and then again to confirm the benefits, and another of holding just one trial to seek the nod with long-term follow-up.
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