Patient-clinician agreement for symptomatic adverse events in phase 1 trials appeared moderate to poor, suggesting clinicians are underreporting toxicity, according to a study published in the Journal of the National Cancer Institute.
Ethan Basch, MD, MSc, the Richard M. Goldberg Distinguished Professor of Medical Oncology and director of the UNC Cancer Outcomes and Research Program at UNC Lineberger Comprehensive Cancer Center, wrote an editorial accompanying the study, with Christina Yap, PhD, professor of clinical trials biostatistics at The Institute of Cancer Research in the UK.
“This study represents a “meaningful contribution” to understanding the use of patient-reported outcomes in phase 1 trials,” wrote Basch and Yap. However, they recognized the need for clarity in how such information should best be used in early-phase trials.
“To achieve patient-centered drug development, methods are needed for integrating patient-reported outcomes into early-phase trials. Substantial strides have been made in this direction. Patients are the ultimate recipients of drugs, so their perspectives are essential to determining tolerability.”
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