Clinical and Translational Science Institute, University of California, San Francisco, San Francisco, California, USA.
Acad Med. 2011 Feb;86(2):217-23. doi: 10.1097/ACM.0b013e3182045059.
Investigator-initiated research involving investigational drugs and devices is key to improving health. However, this requires the investigator to serve as a "sponsor-investigator," which can be complex and overwhelming. The Investigational New Drug/Investigational Device Exemption (IND/IDE) Taskforce of the Clinical and Translational Science Award (CTSA) consortium carried out a survey to examine how academic health centers (AHCs) assist sponsor-investigators with regulatory responsibilities.
The 24 CTSA centers existing in 2008 were surveyed regarding regulatory oversight and support for sponsor-investigators. Responses were analyzed by descriptive statistics. The evaluation of survey responses yielded three models of institutional support/oversight.
Nineteen centers and one affiliate responded. Eleven (55%) reported having an IND/IDE support office, increased from five (25%) prior to their CTSA award. The volume of investigator-initiated IND/IDE research was highly variable (measured by numbers of investigators, IND/IDE applications, and studies). Oversight, if done, was provided by either the IND/IDE office or elsewhere in the institution. Most IND/IDE offices assisted with IND/IDE submissions and preparation for external audits. Half reported advanced training for sponsor-investigators. Almost all reported a goal to increase IND/IDE research. Important issues include the need for robust training of investigator/staff, appropriate determination of IND-exempt research, and sufficient support for preparing IND/IDE applications.
Investigator-initiated research involving IND/IDEs is essential, but complex. AHCs should examine how they support sponsor-investigators in meeting the complex requirements. A model of either expert consultation/support or full service will minimize risks to participants and institutions, and regulatory noncompliance.
涉及研究性药物和器械的研究者发起的研究对于改善健康至关重要。然而，这需要研究者担任“发起研究者-赞助商”，这可能会很复杂和繁重。临床与转化科学奖（CTSA）联盟的研究性新药/研究性器械豁免（IND/IDE）工作组进行了一项调查，以研究学术医疗中心（AHCs）如何协助发起研究者履行监管职责。
对 2008 年存在的 24 个 CTSA 中心进行了关于监管监督和对发起研究者的支持的调查。通过描述性统计对回复进行了分析。对调查回复的评估得出了三种机构支持/监督模式。
19 个中心和一个分支机构做出了回应。其中 11 个（55%）报告设有 IND/IDE 支持办公室，比 CTSA 奖项获得前的 5 个（25%）有所增加。研究者发起的 IND/IDE 研究的数量差异很大（通过研究人员数量、IND/IDE 申请和研究来衡量）。如果进行监督，则由 IND/IDE 办公室或机构的其他地方提供。大多数 IND/IDE 办公室协助 IND/IDE 提交和外部审计准备。有一半的机构报告对发起研究者进行了高级培训。几乎所有机构都报告了增加 IND/IDE 研究的目标。重要问题包括需要对研究者/员工进行强化培训、适当确定 IND 豁免研究、以及为准备 IND/IDE 申请提供足够的支持。
涉及 IND/IDEs 的研究者发起的研究至关重要，但也很复杂。AHCs 应检查如何支持发起研究者以满足复杂的要求。专家咨询/支持或全方位服务的模式将最大限度地降低参与者和机构的风险，并避免监管不合规。
