A systematic analysis of new commercial investigational new drug applications (IND) submitted to the FDA's Office of Hematology and Oncology Products (OHOP) in the Center for Drug Evaluation and Research was conducted to quantify the most common reasons INDs for oncology indications go on clinical hold. In OHOP, less than 10% of INDs went on hold or were withdrawn within the 30-day safety review period. Of INDs that were placed on hold, deficiencies were mainly clinical, followed by concerns related to pharmaceutical quality and nonclinical development. INDs were also characterized based on phase of development, product type, sponsors' regulatory experience, and occurrence of a pre-IND meeting. INDs that were placed on hold were mostly for first-in-human trials or submitted by sponsors with limited regulatory experience. INDs that went on hold or were safe-to-proceed had pre-IND meetings with comparable rates but sponsors with substantial experience appeared to benefit more from pre-IND meetings compared to those with limited experience. The time interval between the pre-IND meeting and the IND submission was longer for INDs that went on hold. To obtain useful FDA feedback on product development, it is essential to provide focused questions and supporting information in pre-IND meeting packages.

中文翻译：

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FDA对影响肿瘤产品的研究新药应用的临床保留缺陷进行的分析。

对在药物评估和研究中心提交给FDA血液和肿瘤学产品办公室（OHOP）的新商业研究用新药申请（IND）进行了系统分析，以量化INDs继续用于临床适应症的最常见原因。在OHOP中，不到30％的IND在30天的安全审核期内被搁置或撤回。在被搁置的IND中，缺陷主要是临床方面，其次是有关药物质量和非临床发展的担忧。还根据开发阶段，产品类型，赞助商的监管经验以及IND前会议的召开来确定IND的特征。被搁置的IND主要用于首次人体试验或由监管经验有限的申办者提交。处于暂停状态或可以安全处理的IND举行的IND前会议的费用相近，但是与经验有限的赞助商相比，经验丰富的赞助商似乎会从IND之前的会议中受益更多。对于保留的IND，IND前会议与IND提交之间的时间间隔更长。为了获得FDA对产品开发的有用反馈，在IND前会议套餐中提供重点问题和支持信息至关重要。