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

  • Topical Collection on Health Economics (N Khera, Section Editor)
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Abstract

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.

Summary

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.

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Funding

Dr. Miller received funding from the National Cancer Institute (K07CA211959). Dr. Aplenc received funding from an Alex’s Lemonade Stand Foundation Epidemiology Grant and the Children’s Hospital of Philadelphia Hematologic Malignancy Research Fund.

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Authors and Affiliations

  1. Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, 2015 Uppergate Drive, Atlanta, GA, 30322, USA

    Tamara P. Miller

  2. Department of Pediatrics, Emory University School of Medicine, Atlanta, GA, USA

    Tamara P. Miller

  3. Division of Oncology, Children’s Hospital of Philadelphia, Philadelphia, PA, USA

    Richard Aplenc

  4. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA

    Richard Aplenc

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  1. Tamara P. Miller
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Correspondence to Tamara P. Miller.

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Miller, T.P., Aplenc, R. Evolution of Hematology Clinical Trial Adverse Event Reporting to Improve Care Delivery. Curr Hematol Malig Rep 16, 126–131 (2021). https://doi.org/10.1007/s11899-021-00627-3

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