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赶紧等待:生物标志物资格计划的时间表和外卖

Grace Collins¹, Jeff D Allen², Hillary S Andrews²

¹Friends of Cancer Research, 1800 M Street NW, Suite 1050 South, Washington, DC, USA. gcollins@focr.org.

Therapeutic innovation & regulatory science

|October 27, 2025

概括

生物标志物合格计划 (BQP) 促进了一些生物标志物开发,但对新型代用终点的成功程度有限. 较长的时间表表明,BQP可能不适合推进这些响应生物标志物.

科学领域:

生物标志物开发生物标志物开发
监管科学监管科学
药物开发工具药物开发工具

背景情况:

生物标志物合格计划 (BQP) 成立于2016年,旨在促进用于监管的新生物标志物的开发.
本研究评估了八年的BQP经验,以评估其在合格新生物标志物的有效性.

研究的目的:

评估生物标志物资格计划 (BQP) 在促进新生物标志物资格方面的有效性.
确定BQP过程中的趋势和挑战,特别是替代终点生物标志物.

主要方法:

已接受的生物标志物资格项目数据来自FDA的药物开发工具资格项目搜索数据库.
分析了61个受理项目的特点和提交日期.

主要成果:

安全,诊断和PD响应生物标志物是最常见的;分子和放射/成像方法占主导地位.
一半的项目在意向书 (LOI) 阶段停滞不前,只有八个生物标志物完全合格.
审查时间表经常超过目标,资格计划 (QP) 开发是漫长的,特别是替代终点.

结论:

BQP支持某些生物标志物类型,但由于开发时间延长,对新型代用终点的实用性有限.
该计划可能不太适合推进新型反应生物标志物.
一个专门的计划可以更好地支持开发新的替代措施,用于更广泛的药物开发应用.

关键词:

生物标志物生物标志物终点终点是一个终点.美国食品药品监督管理局 FDA FDA 在瘤学瘤学.资格资格资格资格.

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