| 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/