| Element Name | StudyEstimand |
|---|---|
| Parent Element(s) | MetaDataVersion |
| Element XPath(s) | /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand |
| Element Textual Value | None |
| Usage | Conditional. |
| Attributes | OID, Name |
| Child Elements | (Description?, StudyTargetPopulationRef?, StudyInterventionRef?, StudyEndpointRef?, IntercurrentEvent*, SummaryMeasure?) |
| 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. |
The International Committee for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) introduced the framework of estimands in 2019 as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses and interpretation of results. ICH has recognized that a precise definition of the scientific question of interest is required to ensure alignment between objectives, trial design, data collection, analysis and interpretation.
In the guidance, an estimand is defined as "... the target of estimation to address the scientific question of interest posed by the trial objective".
The ICH defined study estimands as having five attributes:
- population
- treatment
- variable (endpoint)
- intercurrent events (events that can occur post-randomization)
- summary measure
Element description: TODO
very probably each of these 5 attributes will come as child elements, some of them referencing other elements (StudyEndPointRef, xxxEventRef, ...)