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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Sethi, SS; Kramer, JM; Gagnon, S; Nadzan, G; Vega, JM

Published Date

  • November 2014

Published In

Volume / Issue

  • 48 / 6

Start / End Page

  • 741 - 748

PubMed ID

  • 30227477

Pubmed Central ID

  • 30227477

Electronic International Standard Serial Number (EISSN)

  • 2168-4804

Digital Object Identifier (DOI)

  • 10.1177/2168479014532260

Language

  • eng

Conference Location

  • Switzerland