Support for Investigator-Initiated Clinical Research Involving Investigational Drugs or Devices: The Clinical and Translational Science Award Experience
Support for Investigator-Initiated Clinical Research Involving Investigational Drugs or Devices: The Clinical and Translational Science Award Experience
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DOI：
10.1097/acm.0b013e3182045059
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发表时间：
2011-02-01
影响因子：
7.4
通讯作者：
Speicher, Lisa A.
中科院分区：
文献类型：
--
作者：
Berro, Marlene;Burnett, Bruce K.;Speicher, Lisa A.
研究目的研究者发起的涉及试验药物和器械的研究是改善健康的关键。然而，这需要调查员充当“调查员”，这可能是复杂和压倒性的。临床和转化科学奖（CTSA）财团的研究新药/研究器械豁免（IND/IDE）工作组进行了一项调查，以研究如何学术健康中心（AHCs）协助临床研究者与监管responsibility.MethodThe 24 CTSA中心现有的2008年进行了调查监管监督和支持临床研究者。通过描述性统计分析应答。调查响应的评价产生了三种模式的机构支持/supervisory.ResultsNineteen中心和一个附属机构作出回应。11家（55%）报告拥有IND/IDE支持办公室，比CTSA授予前的5家（25%）有所增加。制药商发起的IND/IDE研究的数量变化很大（通过研究者数量、IND/IDE申请和研究来衡量）。如果进行了监督，则由IND/IDE办公室或机构的其他部门进行监督。大多数IND/IDE办公室协助IND/IDE提交和准备外部稽查。一半的人报告说，他们接受了高级调查员培训。几乎所有人都报告了增加IND/IDE研究的目标。重要的问题包括需要强有力的培训研究者/工作人员，适当确定IND豁免的研究，并为准备IND/IDE application.ConclusionsInvestigator-Initiated的研究，涉及IND/IDE的申请足够的支持是必不可少的，但复杂。AHC应该检查他们如何支持调查人员满足复杂的要求。专家咨询/支持或全面服务的模式将最大限度地减少参与者和机构的风险以及监管违规行为。
PurposeInvestigator-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.MethodThe 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.ResultsNineteen 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.ConclusionsInvestigator-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.