Support for Investigator-Initiated Clinical Research Involving Investigational Drugs or Devices: The Clinical and Translational Science Award Experience

被引：17

作者：

Berro, Marlene ^{[2
]}

Burnett, Bruce K. ^{[3
]}

Fromell, Gregg J. ^{[4
,5
]}

Hartman, Karen A. ^{[6
]}

Rubinstein, Eric P. ^{[7
]}

Schuff, Kathryn G. ^{[1
]}

Speicher, Lisa A. ^{[8
]}

机构：

[1] Oregon Hlth & Sci Univ, Div Endocrinol L607, Oregon Clin & Translat Res Inst, Regulatory Support Serv, Portland, OR 97239 USA

[2] Univ Calif San Francisco, Clin & Translat Sci Inst, San Francisco, CA 94143 USA

[3] Duke Univ, Sch Med, Duke Translat Med Inst, Durham, NC USA

[4] Univ Penn, Sch Med, Off Human Res, Philadelphia, PA 19104 USA

[5] Univ Penn, Inst Translat Med & Therapeut, Philadelphia, PA 19104 USA

[6] Mayo Clin, Off Res Regulatory Support, Rochester, MN USA

[7] Univ Rochester, Off Regulatory Support, Clin & Translat Sci Inst, Rochester, NY USA

[8] Childrens Hosp Philadelphia, Off Clin & Translat Res, Clin Trials Off, Philadelphia, PA 19104 USA

来源：

ACADEMIC MEDICINE | 2011年 / 86卷 / 02期

基金：

美国国家卫生研究院;

关键词：

D O I：

10.1097/ACM.0b013e3182045059

中图分类号：

G40 [教育学];

学科分类号：

040101 ; 120403 ;

摘要：

Purpose 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. Method 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. Results 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. Conclusions 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.

引用

页码：217 / 223

页数：7

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