title: The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative.
abstract: Sponsors of human drug and biologic products subject to an investigational new drug (IND) application are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and the FDA to assure the protection of human subjects participating in clinical trials. On September 29, 2010, the FDA issued a final rule amending its regulations governing expedited IND safety reporting requirements that revised the definitions used for reporting and clarified when to submit relevant and useful information to reduce the number of uninformative reports distributed by sponsors. From January 1, 2006, to December 31, 2014, the FDA's Office of Hematology and Oncology Products received an average of 17,686 expedited safety reports per year. An analysis of FDA submissions by commercial sponsors covering this time period suggested a slight increase in the number of expedited safety reports per IND per year after publication of the final rule. An audit of 160 randomly selected expedited safety reports submitted to the FDA's Office of Hematology and Oncology Products in 2015 revealed that only 22 (14%) were informative. The submission of uninformative expedited safety reports by commercial sponsors of INDs continues to be a significant problem that can compromise detection of valid safety signals. Clin Cancer Res; 22(9); 2111-3. ©2016 AACR.
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Jarow
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Sandra
authors.initials: S
authors.lastname: Casak
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Meredith
authors.initials: M
authors.lastname: Chuk
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Ehrlich
authors.affiliation: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. sean.khozin@fda.hhs.gov.
authors.forename: Sean
authors.initials: S
authors.lastname: Khozin
mesh_terms: D017277:Drug Approval / Q000379:methods; D015507:Drugs, Investigational / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D017387:Investigational New Drug Application / Q000379:methods; D008495:Medical Oncology / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational