StudyEndPoint

Element Name	StudyEndPoint
Parent Element(s)	StudyEndPoints
Element XPath(s)	/ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint
Element Textual Value	None
Attributes	OID, Name, Type, Level
Child Elements	(Description? FormalExpression*)
Usage/Business Rules

Attribute	Schema Datatype or Enumeration	Usage	Definition	Business Rule(s)
OID	oid	Required	Unique identifier for the StudyEndPoint element	The OID attribute for the StudyEndPoint must be unique within the study.
Name	name	Required	Human readable identifier for the StudyEndPoint element.	The Name must be unique within the set of StudyEndPoints elements for the study.
Type	(Simple \| Humane \| Surrogate \| Composite)	Optional	The type of end point. Simple: measures the change of a single outcome that is meaningful in the context of the disease being studied. Humane: the point at which pain and/or distress is terminated, minimized, or reduced. Surrogate: a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship (e.g., a biomarker). Combined: end point that is a combination of several measures. Example: A heart attack study may report the incidence of the combined endpoint of chest pain, myocardial infarction, or death.
Level	(Primary \| Secondary \| Exploratory)	Optional	Level for the Study Endpoint. Primary endpoint(s) are typically efficacy measures that address the main research question [1] Secondary endpoints are generally not sufficient to influence decision-making alone, but may support the claim of efficacy by demonstrating additional effects or by supporting a causal mechanism. [2] Exploratory endpoints (where nominated) typically capture outcomes that occur less frequently or which may be useful for exploring novel hypotheses. [1]	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/}

A study end point reflects an outcome measure of interest that is statistically analyzed to address a particular research question for the study.
It typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined

End points are typically associated with study objectives.

Example

StudyEndPoint

<StudyEndPoint OID="SEP.WEIGHT_LOSS" Name="Weight loss end point">
    <Description>
        <TranslatedText xml:lang="en" Type="text/plain">Absolute change from baseline weight at 1 year</TranslatedText>
        <FormalExpression Context="ODMPath">
            StudyEventData.where(StudyEventOID='SE.VISIT1').ItemGroupData.where(ItemGroupOID='IG.VITALS').ItemData.where(ItemOID='IT.WEIGHT).Value 
            - StudyEventData.where(StudyEventOID='SE.VISIT_1_YEAR').ItemGroupData.where(ItemGroupOID='IG.VITALS').ItemData.where(ItemOID='IT.WEIGHT).Value</FormalExpression>
    </Description>
</StudyEndPoint>

Page tree

StudyEndPoint