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Slow, Costly Clinical Trials Drag Down Biomedical Breakthroughs

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The biotechnology industry is on the brink of making advances that will amount to secular miracles, from restoring sight to the blind[1] to exorcising cancer through gene-edited immune cells.[2] That progress is threatened, however, by the extremely high, and rapidly increasing, cost of running clinical trials. If we do not bring these costs down, we risk either waiting too long for efficacious drugs or paying for drugs that may not work at all. As the global leader[3] of the biotech industry, the U.S. should lead the way in generating rigorous evidence in clinical trials. To that end, this brief proposes six important reforms: Clinical drug trials are very expensive. According to one estimate, for trials conducted in 2015–17, the median cost was $41,413 per patient.[4] But in some trials, that figure is significantly higher. According to George Yancopoulos, cofounder and chief scientific officer of Regeneron, per-patient costs can now reach $500,000—a stark increase from the $10,000 p

View all Articles Health Drug Development, FDA Reform May 16th, 2023 15 Minute Read Issue Brief by Willy Chertman Share Download PDF Slow, Costly Clinical Trials Drag Down Biomedical Breakthroughs Photo: Kkolosov/iStock Table of Contents Introduction The biotechnology industry is on the brink of making advances that will amount to secular miracles, from restoring sight to the blind[ 1 ] to exorcising cancer through gene-edited immune cells.[ 2 ] That progress is threatened, however, by the extremely high, and rapidly increasing, cost of running clinical trials. If we do not bring these costs d

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