November 14 2023
Written by: Donna Angel Carico, Atrium Health Wake Forest Baptist, Comprehensive Cancer Center, Winston-Salem, NC
Establishing the safety of new and improved treatment regimens in cancer care is often the first objective in clinical research. This creates an overarching need to standardize best practices in adverse event (AE) reporting across the clinical research continuum. An adverse event is defined by the NCI as “an untoward or unfortunate medical occurrence associated with the use of a drug in humans, whether or not considered drug related”. Standard adverse event reporting in oncology clinical trials is assessed by utilizing the Common Terminology Criteria for Adverse Events (CTCAE), created by the National Cancer Institute. Adverse events may reflect laboratory abnormalities, physical examination changes, functional status variations, and patient-elicited toxicities.Collection of AEs begins at baseline and continues until 30-days after the end of protocol treatment or longer depending on protocol-specific reporting requirements. At baseline, sites should document all AEs regardless of relationship to protocol treatment and report as outlined in the protocol document. For example, Grade 1 anemia may not be a reportable event, but Grade 2 anemia is, so sites would need to have documentation of the Grade 1 anemia to support when the anemia advanced to a Grade 2. If the AE recurs or increases in grade after initiation of protocol treatment, then the AE must be reported to NRG per protocol requirements.
As part of a good clinical best practice, NRG recommends that an AE log be part of the source documentation. An AE log must include the start and end dates by grade change and decision making regarding expedited reporting.An AE log will support the EDC Adverse Event reporting requirements that mandate start and end dates for each change in grade until it is resolved.A great way to have this done in real time, is to require the research nurse/coordinator that is seeing the patient, document and grade any AEs during their visit into the Electronic Medical Record (EMR).From there, the CRA/Data Manager can extract the information and enter it into the EDC after the treating physician has assigned the drug attribution. If using paper AE logs, the treating physician should date and sign the original copy of the Adverse Event log as a source document.
At Atrium Health Wake Forest Baptist Comprehensive Cancer Center, we have recently implemented a new Adverse Event Reporting system with all new research studies including, NRG-sponsored trials. We are now utilizing EPICs AE Module functionality to track new events in real time.When a patient is seen for a protocol-required visit, the clinical team (i.e., nurse, coordinator, and provider) documents all toxicities in the AE module, which links directly to the protocol-specified version of the CTCAE. The events then get pushed to the physician for review of grade, start/stop dates and to assign attribution and expectedness.The expectation is for this process to happen while the patient remains in clinic so that any discrepancies can be clarified and documented in real time. Our site also utilizes EMR functionality for notifications of appointment changes and/or admissions of all patients linked to a clinical trial.
So, what is the best practice?It depends on your organization as to whether you report Adverse Events through the paper AE log route or electronically through your EMR system.It is vital for each member of the clinical research team to be on the same page as to how events are reported so that AEs are reported properly.Make sure everybody knows the proper reporting procedure and make sure all newly trained staff are aware of your site’s procedures.The best practice for reporting Adverse Events is what works for your site and making sure that all team members are aware of the procedures. A good idea would be to have frequent meetings to make sure Adverse Event reporting is a process that everyone is familiar with so that no reportable event goes unreported.