Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery.

TitleEvolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery.
Publication TypeJournal Article
Year of Publication2021
AuthorsMiller TP, Aplenc R
JournalCurr Hematol Malig Rep
Date Published2021 Mar 30

PURPOSE OF REVIEW: Reporting of adverse events on hematology clinical trials is crucial to understanding the safety of standard treatments and novel agents. However, despite the importance of understanding toxicities, challenges in capturing and reporting accurate adverse event data exist.

RECENT FINDINGS: Currently, adverse events are reported manually on most hematology clinical trials. Especially on phase III trials, the highest grade of each adverse event during a reporting period is typically reported. Despite the effort committed to AE reporting, studies have identified underreporting of adverse events on hematologic malignancy clinical trials, which raises concern about the true understanding of safety of treatment that clinicians have in order to guide patients about what to expect during therapy. In order to address these concerns, recent studies have piloted alternative methods for identification of adverse events. These methods include automated extraction of adverse event data from the electronic health record, implementation of trigger or alert tools into the medical record, and analytic tools to evaluate duration of adverse events rather than only the highest adverse event grade. Adverse event reporting is a crucial component of clinical trials. Novel tools for identifying and reporting adverse events provide opportunities for honing and refining methods of toxicity capture and improving understanding of toxicities patients experience while enrolled on clinical trials.

Alternate JournalCurr Hematol Malig Rep
PubMed ID33786724
Grant ListK07CA211959 / CA / NCI NIH HHS / United States