1. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018 Subject(s): Clinical Trials as Topic -- ethicsClinical Trials as Topic -- methodsEthics Committees, ResearchInformed ConsentRandomized Controlled Trials as Topic -- ethicsRandomized Controlled Trials as Topic -- methodsResearch DesignResearch SubjectsHumansEuropeJapanUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019 Subject(s): Double-Blind MethodNeoplasms -- drug therapyPlacebosRandomized Controlled Trials as Topic -- standardsSingle-Blind MethodAntineoplastic AgentsBiological ProductsRandomized Controlled Trials as Topic -- ethicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.