Scientific Publications by FDA Staff

Clin Cancer Res 2016 May 1;22(9):2111-3

The majority of expedited Investigational New Drug safety reports are uninformative.

Jarow JP, Casak S, Chuk M, Ehrlich LA, Khozin S

Sponsors of human drug and biological products subject to an investigational new drug application (IND) are required to distribute expedited safety reports of serious and unexpected suspected adverse reactions to participating investigators and FDA to assure the protection of human subjects participating in clinical trials. On September 29, 2010, 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 in order to reduce the number of uninformative reports distributed by sponsors. From January 1, 2006 to December 31, 2014, FDA's Office of Hematology and Oncology Products received an average of 17,686 expedited safety reports per year. An analysis of the 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 FDA's Office of Hematology and Oncology Products in 2015 revealed that only 22 (14%) were informative. 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.