A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared.
| Element Name | StudyEstimand |
|---|---|
| Parent Elements | StudyEstimands |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand |
| Element Textual Value | None |
| Attributes | OID, Name |
| Child Elements | (Description?, StudyTargetPopulationRef?, StudyInterventionRef?, StudyEndpointRef?, IntercurrentEvent*, SummaryMeasure?) |
| Usage/Business Rules |
| Attribute | Schema Datatype or | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the StudyEstimand element. | The OID attribute value must be unique within the Study/MetaDataVersion. |
| Name | name | Required | Human readable name for the Study Estimand. | The Name attribute must be unique within the Study/MetadataVersion. |
| Level | ( Primary | Secondary | Exploratory ) | Optional | Defined Level for the Study Estimand | These are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol Specification. |
[1] US Department of Health and Human Services F . 2017. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER): Multiple Endpoints for Clinical Trials: Guidance for Industry. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-endpoints-clinical-trials-guidance-industry)
[2] Biomarkers EndpointS and other tools (BEST) http://www.ncbi.nlm.nih.gov/books/NKB338448/