1. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022 Subject(s): Antineoplastic AgentsBiological ProductsClinical Trials as TopicDrug Development -- legislation & jurisprudenceDrug Development -- standardsMedical OncologyUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
2. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022 Subject(s): Antineoplastic AgentsBiological ProductsClinical Trial Protocols as TopicClinical Trials as TopicUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
3. 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.
