1. Special protocol assessment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018 Subject(s): Clinical Protocols -- standardsClinical Trials as Topic -- standardsDrug ApprovalDrug Evaluation, Preclinical -- standardsResearch DesignCarcinogenicity Tests -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.