Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag
Utilization of the Bridging Strategy for the Development of New Drugs in Oncology to Avoid Drug Lag
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DOI：
10.1002/jcph.951
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发表时间：
2017-11-01
影响因子：
2.9
通讯作者：
Hidaka, Shinji
中科院分区：
文献类型：
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作者：
Kogure, Seiji;Koyama, Nobuyuki;Hidaka, Shinji
全球试验（GT）策略和桥接（BG）策略是目前日本肿瘤药物临床开发的主要策略，但开发方式与药物滞后的关系以及桥接策略如何促进药物滞后的解决尚不清楚。我们研究了影响提交滞后（SL）的潜在因素，并比较了早期启动BG策略、晚期启动BG策略和GT策略之间SL的差异。逐步线性回归分析确定了缩短 SL 的潜在因素：开发启动滞后和开发风格。比较各策略之间SL的差异还表明，GT策略和早期启动BG策略中的SL显着短于晚期启动BG策略。我们的研究结果表明，延迟启动 BG 策略可能无助于缩短药物滞后。由于后期启动的BG研究数量并未减少，我们建议首先制药公司应在日本尽早启动临床开发，以便下一步可以首选GT策略；其次，当在1期研究中调查日本人和非日本人的暴露差异后无法选择GT策略时，应选择早期BG策略，以避免未来的药物滞后。监管机构提供合理的指导以对战略决策产生积极影响也很重要，即使对于外资企业也是如此。
Global trial (GT) strategy and bridging (BG) strategy are currently the main clinical development strategies of oncology drugs in Japan, but the relationship between development style and drug lag and how the bridging strategy has contributed to the solution of drug lag have not been clear. We investigated the potential factors that influenced submission lag (SL), and also compared the differences in SL among early-initiation BG strategy, late-initiation BG strategy, and GT strategy. A stepwise linear regression analysis identified the potential factors that shorten SL: development start lag and development style. Comparison of the differences in SL among the strategies also indicated that the SL in the GT strategy and that in the early-initiation BG strategy were significantly shorter than that in the late-initiation BG strategy. The findings in our study suggest that the late-initiation BG strategy may not contribute to shortening drug lag. Because the number of late-initiation BG studies has not decreased, we propose first that pharmaceutical companies should initiate clinical development as early as possible in Japan so that they can choose the GT strategy as a first option at the next step, and second when they cannot choose the GT strategy after investigating differences in exposure between Japanese and non-Japanese in a phase 1 study, they should select the early BG strategy to avoid future drug lag. It is also important for the regulatory authorities to provide reasonable guidance to have a positive impact on strategic decisions, even for foreign-capital companies.