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

Therapeutic Innovation & Regulatory Science
Sundeep S SethiJosé M Vega

Abstract

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...Continue Reading

References

Feb 20, 2008·Clinical Trials : Journal of the Society for Clinical Trials·Lelia DuleySalim Yusuf
May 7, 2013·Clinical Trials : Journal of the Society for Clinical Trials·Kathryn E FlynnKevin P Weinfurt
Nov 25, 2014·Therapeutic Innovation & Regulatory Science·Judith M KramerSusan Ellenberg
Mar 1, 2014·Therapeutic Innovation & Regulatory Science·Patrick ArchdeaconJudith M Kramer

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Citations

Dec 14, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Laura A LevitJulie M Vose
Jul 16, 2019·Clinical Pharmacology and Therapeutics·Mwango KashokiSandra L Kweder

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