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 other details, as applicable, such as how multiple assessments within an individual are to be combined.

End points are typically associated with StudyObjectives. The property whether a study end point is primary or secondary is thus inherited from the StudyObjective that references it.

Element NameStudyEndPoint
Parent Element(s)StudyEndPoints
Element XPath(s)/ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint
Element Textual ValueNone
AttributesOID, Name, Type, Level
Child Elements(Description? FormalExpression*)
Usage/Business Rules

AttributeSchema Datatype
or Enumeration		UsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier for the StudyEndPoint element
  • The OID attribute for the  StudyEndPoint must be unique within the study.
NamenameRequiredHuman 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/

Example: StudyEndPoint

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>

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