Posted by Michael Wonder on 26 Aug 2019
FDA encourages inclusion of male patients in breast cancer clinical trials
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males in breast cancer clinical trials.
Historically, males either have not been included in clinical trials for drugs to treat breast cancer or inclusion of males in those trials has been very limited; when finalised, the draft guidance will provide clarity for industry regarding clinical development of drugs to treat breast cancer in male patients.
