Skip to main content

Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience.

Publication ,  Journal Article
Berro, M; Burnett, BK; Fromell, GJ; Hartman, KA; Rubinstein, EP; Schuff, KG; Speicher, LA ...
Published in: Acad Med
February 2011

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.

Duke Scholars

Published In

Acad Med

DOI

EISSN

1938-808X

Publication Date

February 2011

Volume

86

Issue

2

Start / End Page

217 / 223

Location

United States

Related Subject Headings

  • United States
  • Translational Research, Biomedical
  • Translational Medical Research
  • Surveys and Questionnaires
  • Humans
  • General & Internal Medicine
  • Equipment and Supplies
  • Drugs, Investigational
  • Diffusion of Innovation
  • Data Collection
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Berro, M., Burnett, B. K., Fromell, G. J., Hartman, K. A., Rubinstein, E. P., Schuff, K. G., … IND/IDE Taskforce of the Clinical and Translational Science Award Consortium, . (2011). Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience. Acad Med, 86(2), 217–223. https://doi.org/10.1097/ACM.0b013e3182045059
Berro, Marlene, Bruce K. Burnett, Gregg J. Fromell, Karen A. Hartman, Eric P. Rubinstein, Kathryn G. Schuff, Lisa A. Speicher, and Lisa A. IND/IDE Taskforce of the Clinical and Translational Science Award Consortium. “Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience.Acad Med 86, no. 2 (February 2011): 217–23. https://doi.org/10.1097/ACM.0b013e3182045059.
Berro M, Burnett BK, Fromell GJ, Hartman KA, Rubinstein EP, Schuff KG, et al. Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience. Acad Med. 2011 Feb;86(2):217–23.
Berro, Marlene, et al. “Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience.Acad Med, vol. 86, no. 2, Feb. 2011, pp. 217–23. Pubmed, doi:10.1097/ACM.0b013e3182045059.
Berro M, Burnett BK, Fromell GJ, Hartman KA, Rubinstein EP, Schuff KG, Speicher LA, IND/IDE Taskforce of the Clinical and Translational Science Award Consortium. Support for investigator-initiated clinical research involving investigational drugs or devices: the Clinical and Translational Science Award experience. Acad Med. 2011 Feb;86(2):217–223.

Published In

Acad Med

DOI

EISSN

1938-808X

Publication Date

February 2011

Volume

86

Issue

2

Start / End Page

217 / 223

Location

United States

Related Subject Headings

  • United States
  • Translational Research, Biomedical
  • Translational Medical Research
  • Surveys and Questionnaires
  • Humans
  • General & Internal Medicine
  • Equipment and Supplies
  • Drugs, Investigational
  • Diffusion of Innovation
  • Data Collection