Building a roadmap to biomarker qualification: challenges and opportunities

被引：43

作者：

Amur, Shashi G. ^{[1
]}

Sanyal, Sarmistha ^{[1
]}

Chakravarty, Aloka G. ^{[2
]}

Noone, Marianne H. ^{[1
]}

Kaiser, James ^{[1
]}

McCune, Susan ^{[1
]}

Buckman-Garner, ShaAvhree Y. ^{[1
]}

机构：

[1] US FDA, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[2] US FDA, Office Biostat, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

来源：

BIOMARKERS IN MEDICINE | 2015年 / 9卷 / 11期

关键词：

biomarker; context of use; critical path innovation meeting; evidentiary considerations; international harmonization; letter of support; qualification; regulatory science; statistical considerations; submitter;

D O I：

10.2217/bmm.15.90

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

100103 [病原生物学]; 100218 [急诊医学];

摘要：

The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

引用

页码：1095 / 1104

页数：10

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