Sponsors of clinical trials conducted under investigational new drug (IND) applications are required by the U.S. Food and Drug Administration (FDA) to report serious adverse events (SAEs) that are unexpected and suspected to be related to the drug. However, contrary to FDA guidance, investigators often send SAE reports to sponsors unnecessarily. The high volume of these uninformative reports complicates detection of valid safety signals and increases administrative burden for physician-investigators, research staff, and FDA regulators.
In response to these concerns, ASCO developed a Decision Aid to assist physician-investigators and research staff in determining whether an AE should be reported to the sponsor as an SAE and attributed to the investigational drug.
An article in the Journal of Oncology Practice (JOP) looks at the results of a preliminary study that assessed real-world usage and impact of the Decision Aid. The study found that, while the Decision Aid generally did not increase accuracy in determining seriousness (whether the investigator should submit an SAE report to the sponsor), it did increase accuracy in determining whether an SAE should be attributed to the investigational drug. The majority of study participants indicated that the Decision Aid was helpful and that they would use it in practice.
The study was conceived and executed by an ASCO-led multi-stakeholder taskforce, which included representatives from community and academic research sites, sponsors, and the FDA. The taskforce was assembled as part of ASCO’s multiyear effort to streamline AE reporting.
Read the full article, “Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors” and download the Decision Aid.