A New Approach to Documenting and Reporting of Clinical Trial-Emergent Adverse Events

3:30 PM–4:30 PM May 19, 2020 (Conference Time: US - Pacific)

3:30 PM–4:30 PM May 19, 2020

Regency Prefunction


Abstract: Clinical trial research has been essential to progress in oncology. One of the most important aspects of clinical research is to accurately record and review treatment-emergent adverse events (AEs) to determine if a new intervention provides superior efficacy with acceptable side effects. The standard for adverse event reporting has been the retrospective extraction of adverse events from the medical record by research staff (often individuals with limited medical knowledge) and entry into an adverse event log for each patient which is then entered into electronic case report forms (eCRFs). The standard retrospective methodology is error-prone with potential omission of AEs resulting in delays in identifying treatment-emergent toxicities that may require modification of the clinical trial. We developed a custom EHR-based approach employing a new paradigm for AE reporting that facilitates real-time capture of data, improves accuracy of source documentation and provides investigators with tools to enhance identification of trends in treatment-emergent adverse events.

Describe the new knowledge and additional skills the participant will gain after attending your presentation.: Changing the paradigm for reporting AEs on clinical trials from retrospective to prospective was an initial
hurdle in adoption. However, we demonstrated that an EHR-based AE reporting system can permit realtime
recording of clinical trial AEs enabling enhanced investigator oversight and improved data quality
for study sponsors. Additionally, we hope to demonstrate that, while increasing the amount of information captured in real time, documentation burden is ultimately alleviated by a reduction in sponsor queries.

Participants will gain insight into the initial hurdles, the impact to clinician workflow, and lessons learned during implementation.


Andrew Zelenetz, MSKCC
Monica Allison (Presenter)