Director of the Cancer Outcomes Research Program at the University of North Carolina Lineberger Comprehensive Cancer Center and colleagues at the FDA guide drug developers on how to include meaningful pain endpoints when designing cancer trials.
Pain is a common symptom and can be debilitating for patients with cancer. Clinically significant improvements in pain resulting from a cancer treatment can support drug approval and labeling claims in the United States, when it is adequately measured. Different approaches have been used for measuring pain in cancer clinical trials, with varying levels of rigor.
A new paper published by Cancer describes approaches to pain measurement used in oncology clinical trials submitted to the U.S. Food and Drug Administration that are consistent with current FDA guidance principles. The purpose of the paper is to assist drug developers to include meaningful pain endpoints when designing cancer trials.
“Measurement of pain and other symptoms is an essential part of cancer trials. Without this information, our understanding of how drugs affect people is incomplete,” said lead author Ethan Basch, MD, Director of the Cancer Outcomes Research Program at the University of North Carolina Lineberger Comprehensive Cancer Center. Dr. Basch developed the paper with FDA colleagues while serving as a Guest Worker at the FDA.
The paper outlines several areas that are commonly a challenge in pain analyses, including measuring pain and analgesic use, how to collect pain information from patients, and how to define pain improvements. Examples of how the challenges have been addressed in past trials are provided.