ASCO HAS released recommendations to streamline serious adverse events reporting for cancer clinical trials. The ASCO research statement, published last month in the Journal of Clinical Oncology (JCO), discusses strategies to address the high volume of uninformative adverse events reports submitted to the U.S. Food and Drug Administration (FDA) and investigators.
To protect patient safety, current regulations require research sponsors to report certain serious adverse events experienced by patients in a clinical trial to the FDA and investigators through an expedited process. To qualify for expedited reporting, adverse events must be “suspected adverse reactions that are both serious and unexpected,” according to FDA guidelines.
This definition incorporates three elements, all of which must be met for the event to meet the FDA’s standards for expedited reporting:
- Serious: The event must be serious or life-threatening, such as death, hospitalization, or incapacitation, among others.
- Unexpected: The event is not listed in the study protocol or investigator brochure.
- Suspected: There is a reasonable possibility the study drug caused the event.
The authors assert that the high volume of uninformative reports hinders patient safety and imposes a substantial toll on the FDA, as well as research site time and resources. Acknowledging the persistence of this issue and its negative impact on stakeholders across the research community, ASCO held a workshop in March 2017 on streamlining adverse events reporting and discussed ways to decrease overreporting, as well as best practices for adverse events reporting for sponsors, contract research organizations (CROs), and research sites, which helped to inform ASCO’s statement.
ASCO’s recommendations to streamline these reports include:
- Sponsors and CROs should adopt best practices for reporting adverse events
- Researchers and research sites should adopt best practices for reporting adverse events to sponsors
- International regulatory agencies should harmonize the regulations for adverse events reporting
- All stakeholders should use modern, digital technology to report adverse events.
Read the full statement in the Journal of Clinical Oncology by visiting http://ascopubs.org/doi/ full/10.1200/JCO.2017.75.8193, and stay connected to the latest news in cancer policy on ASCO in Action by visiting https://www.asco.org/advocacy-policy/ asco-in-action. ■
© 2018. American Society of Clinical Oncology. All rights reserved.
