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Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.

Publication ,  Journal Article
Sethi, SS; Kramer, JM; Gagnon, S; Nadzan, G; Vega, JM
Published in: Ther Innov Regul Sci
November 2014

Due to investigators' complaints about the volume and limited interpretability of expedited safety reports received in Investigational New Drug (IND) studies, the authors surveyed industry sponsors in late 2009 about their reporting practices. An Internet-enabled survey was submitted to 51 industry sponsors. Ten (20%) complete surveys were returned, 9 of which came from large pharmaceutical/biotechnology companies. Although the response rate in this study was low, considering the consolidation present in this sector, the preponderance of responses from large pharmaceutical companies provides a useful description of the safety reporting practices of a significant sector within the medical products industry. Sponsors described extensive safety-specialized resources for reporting individual events to the FDA and IND investigators. Aggregate reports, when prepared, were provided to the FDA but rarely to investigators. Sponsors reported receiving complaints from investigators about excessive volume and limited relevance of individual safety reports. These data suggest that investigators would likely benefit if industry sponsors decreased reporting of individual cases that are not readily interpretable and instead reported meaningful safety information from aggregate analyses.

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Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

November 2014

Volume

48

Issue

6

Start / End Page

741 / 748

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics
 

Citation

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Sethi, S. S., Kramer, J. M., Gagnon, S., Nadzan, G., & Vega, J. M. (2014). Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND. Ther Innov Regul Sci, 48(6), 741–748. https://doi.org/10.1177/2168479014532260
Sethi, Sundeep S., Judith M. Kramer, Suzanne Gagnon, Greg Nadzan, and José M. Vega. “Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.Ther Innov Regul Sci 48, no. 6 (November 2014): 741–48. https://doi.org/10.1177/2168479014532260.
Sethi SS, Kramer JM, Gagnon S, Nadzan G, Vega JM. Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND. Ther Innov Regul Sci. 2014 Nov;48(6):741–8.
Sethi, Sundeep S., et al. “Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND.Ther Innov Regul Sci, vol. 48, no. 6, Nov. 2014, pp. 741–48. Pubmed, doi:10.1177/2168479014532260.
Sethi SS, Kramer JM, Gagnon S, Nadzan G, Vega JM. Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND. Ther Innov Regul Sci. 2014 Nov;48(6):741–748.
Journal cover image

Published In

Ther Innov Regul Sci

DOI

EISSN

2168-4804

Publication Date

November 2014

Volume

48

Issue

6

Start / End Page

741 / 748

Location

Switzerland

Related Subject Headings

  • Statistics & Probability
  • 4905 Statistics
  • 3214 Pharmacology and pharmaceutical sciences
  • 1117 Public Health and Health Services
  • 0104 Statistics