| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | These are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol Specification 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) , they typically capture outcomes that occur less frequently or which may be useful for exploring novel hypotheses. [1] |
[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/