On March 8, ASCO held a workshop on streamlining adverse events (AE) reporting for cancer clinical trials. Led by ASCO Past President Julie M. Vose, MD, MBA, FASCO, and ASCO President Daniel F. Hayes, MD, FACP, FASCO, the workshop focused on developing a roadmap for making AE reporting as meaningful and informative as possible and overcoming current issues with the reporting process. More than 40 participants—stakeholders from across the cancer research community, including researchers, industry representative, and Food and Drug Administration (FDA) and National Cancer Institute officials—attended the event at ASCO headquarters in Alexandria, Va.
The all-day event kicked off with discussions on existing regulatory requirements for AE reporting, current efforts to improve AE reporting, and industry and contract research organizations’ (CROs) perspectives on risk. FDA officials highlighted the toll on the agency’s resources resulting from current over-reporting of adverse events in clinical trials, as well as the time and resources of researchers who receive theses notice. Industry representatives noted the challenge of meeting the divergent reporting requirements between international agencies.
In breakout sessions, participants then explored best practices in AE reporting, from both the perspectives of sponsors and CROs, and researchers and research sites. One breakout session also explored technology utilization and proposed possible ways to improve and streamline technology to facilitate better AE reporting.
The workshop built off a collaboration between ASCO and the Association of American Cancer Institutes (AACI): The Best Practices in Cancer Clinical Trials Initiative—a project spearheaded by Dr. Vose during her ASCO presidential term with the aim of developing and promoting practical solutions to meeting administrative and regulatory requirements in clinical cancer research. ASCO will continue to engage stakeholders to act on solutions proposed at the Streamlining Adverse Events Reporting Workshop and build off the work of the ASCO-AACI Best Practices in Cancer Clinical Trials Initiative. The society plans to develop a summary of the meetings recommendations and hold future meetings with stakeholder groups to discuss this important issue.