title: Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting Rule.
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.
authors.affiliation: Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Judith M
authors.initials: JM
authors.lastname: Kramer
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA ; Dr. Vock is currently affiliated with the University of Minnesota, Minneapolis, MN, USA.
authors.forename: David
authors.initials: D
authors.lastname: Vock
authors.affiliation: American College of Clinical Pharmacology, Rockville, MD, USA ; Department of Pharmacology and Clinical Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA ; Dr. Greenberg is currently affiliated with Janssen Pharmaceuticals, Titusville, NJ, USA.
authors.forename: Howard E
authors.initials: HE
authors.lastname: Greenberg
authors.affiliation: Duke Translational Medicine Institute, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
authors.forename: Cheri
authors.initials: C
authors.lastname: Janning
authors.affiliation: Department of Medicine, Duke University School of Medicine, Durham, NC, USA ; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA ; Dr. Szczech is currently affiliated with FibroGen Inc, San Francisco, CA, USA.
authors.forename: Lynda
authors.initials: L
authors.lastname: Szczech
authors.affiliation: Genentech, South San Francisco, CA, USA ; Dr. Salgo has retired from Genentech.
authors.forename: Miklos
authors.initials: M
authors.lastname: Salgo
authors.affiliation: ICON Clinical Research, North Wales, PA, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Gagnon
authors.affiliation: University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Ellenberg
keywords: IND safety reports; clinical research sites; clinical trials; expedited safety reports; safety reporting; serious adverse events