The U.S. Food and Drug Administration (FDA) on August 26 released a draft guidance that urges researchers to include men in breast cancer clinical trials.
Although less than 1% of all breast cancer cases occur in men, men are more likely to be diagnosed at an older age and have a more advanced stage of disease, noted Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, in a statement released by the agency.
"When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a variety of trial designs using different data sources, including studies using real-world data," Pazdur stated.
The FDA is taking comment on the guidance through October 26.
