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- NCIT_C191276 IAO_0000115 "A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. (FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022)" @default.
- NCIT_C191276 NCIT_NHC0 "C191276" @default.
- NCIT_C191276 NCIT_P106 "Research Activity" @default.
- NCIT_C191276 NCIT_P108 "Expansion Cohort Trial" @default.
- NCIT_C191276 NCIT_P208 "CL1904859" @default.
- NCIT_C191276 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C191276 NCIT_P325 "A predominantly First-in-Human (FIH) trial with a single protocol with an initial dose-escalation phase followed by three or more additional subject cohorts with cohort-specific objectives. NOTE: The objectives of these expansion cohorts can include assessment of antitumor activity in a disease-specific setting, assessment of a dose with acceptable safety in specific populations (e.g., pediatric or elderly subjects, subjects with organ impairment, subjects with specific tumor types), evaluation of alternative doses or schedules, establishment of dose and schedule for the investigational drug administered with another oncology drug, or evaluation of the predictive value of a potential biomarker. In general, comparison of activity between cohorts is not planned except when a prespecified randomization and analysis plan are part of the protocol design. [FDA Guidance: Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. March 2022]" @default.
- NCIT_C191276 normalizedInformationContent "100" @default.
- NCIT_C191276 referenceCount "1" @default.
- NCIT_C191276 hasExactSynonym "Expansion Cohort Trial" @default.
- NCIT_C191276 hasExactSynonym "expansion cohort trial" @default.
- NCIT_C191276 inSubset NCIT_C61410 @default.
- NCIT_C191276 inSubset NCIT_C67497 @default.
- NCIT_C191276 type Class @default.
- NCIT_C191276 isDefinedBy ncit.owl @default.
- NCIT_C191276 label "Expansion Cohort Trial" @default.
- NCIT_C191276 subClassOf NCIT_C15206 @default.
- NCIT_C191276 subClassOf NCIT_C15208 @default.
- NCIT_C191276 subClassOf NCIT_C15273 @default.
- NCIT_C191276 subClassOf NCIT_C15429 @default.
- NCIT_C191276 subClassOf NCIT_C16203 @default.
- NCIT_C191276 subClassOf NCIT_C191276 @default.
- NCIT_C191276 subClassOf NCIT_C43431 @default.
- NCIT_C191276 subClassOf NCIT_C63536 @default.
- NCIT_C191276 subClassOf NCIT_C70821 @default.