Precision medicine offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested and patient burden needed to achieve first FDA license for all 5 novel anti-cancer precision-medicine drugs and all 10 novel non-precision medicine drugs receiving FDA approval 2010-2014. The 15 drug portfolios encompassed 242 trials: 87 for precision medicine drugs and 155 for non-precision medicine drugs. Embase and MEDLINE databases were searched for all pre-licensure clinical trials, and data on time, patient numbers, indications tested and total treatment-emergent grade 3-5 adverse events were measured from the first trial of each drug. We did not find patterns suggesting greater efficiencies in precision medicine compared to non-precision medicine. Gains in efficiency for precision-medicine drug development may be offset by challenges with recruitment.

中文翻译：

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精准医学对癌症新药开发效率的影响。

精密医学为减少与药物开发相关的成本，负担和时间提供了机会。我们检查了获得2010-2014年FDA批准的所有5种新型抗癌精密药物和所有10种新型非精密药物获得FDA首次FDA许可所需的时间，试验次数，测试的适应症和患者负担。15种药物组合包括242个试验：精密药物87个和非精密药物155个。从Embase和MEDLINE数据库中搜索所有许可前的临床试验，并从每种药物的第一次试验中测量时间，患者人数，测试适应症和总治疗紧急3至5级不良事件的数据。我们没有发现模式表明与非精密医学相比，精密医学具有更高的效率。