Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule

Judith M. Kramer, David Vock, Howard E. Greenberg, Cheri Janning, Lynda Szczech, Miklos Salgo, Suzanne Gagnon, Susan Ellenberg

Research output: Contribution to journalReview articlepeer-review

4 Scopus citations

Abstract

Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigators were asked to (1) prospectively document time to process IND safety reports and (2) retrospectively review safety reports from a previous 3-month period, documenting resultant actions. In this limited sample, sites spent a median of 0.25 hours per report at a median cost of US$22. Few expedited safety reports were retrospectively said to have changed study conduct or informed consent. However, a low response rate and the concentration of clinical sites in a single therapeutic area preclude generalizing these results. The authors discuss the challenges in gaining investigators' cooperation to evaluate the impact of regulatory requirements. Better methods to facilitate this type of research will enrich the scientific basis of future clinical trial regulation and guidance.

Original languageEnglish (US)
Pages (from-to)413-419
Number of pages7
JournalTherapeutic Innovation and Regulatory Science
Volume48
Issue number4
DOIs
StatePublished - Jul 2014

Bibliographical note

Funding Information:
This study was conducted through in-kind contribution of effort by authors and organizations working with the Clinical Trials Transformation Initiative (CTTI; www.ctti-clinicaltrials.org ), as well as staff effort and meetings supported by CTTI funding (derived both from pooled membership fees of member organizations and from cooperative agreement U19FD003800 awarded to Duke University from the U.S. Food and Drug Administration). Amgen contributed a part-time project manager supported by a CTTI staff member. ICON contributed programming and data management services supplemented by a CTTI staff member. ICON, Duke Clinical Research Institute, and the University of Pennsylvania all contributed to the statistical analysis.

Keywords

  • IND safety reports
  • clinical research sites
  • clinical trials
  • expedited safety reports
  • safety reporting
  • serious adverse events

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