Objective & Endpoint level

[dih-cdisc]

See JIRA DDF-440 & DDF-438

DDF-440

"What is the significance of Level for endpoints? We normally have endpoints tagged to Primary/Secondary objectives."

DDF-438

"This came up in the Exchange call (cc: Lex Jansen ). In the ODM we have StudyObjective -> Type with enumerations Primary/Secondary and Exploratory (https://wiki.cdisc.org/display/ODM2/StudyObjective) and StudyEndPoints (https://wiki.cdisc.org/display/ODM2/StudyEndPoint) with Type enumerated as (Simple | Humane | Surrogate | Composite). Should we change the Type attribute of StudyObjective to Level to align?

We're not sure that Level makes sense in terms of Endpoints; can endpoints not support multiple objectives (some of which could be primary or secondary or exploratory). Are the Endpoint Levels aligned with the Objective Levels? "

[EMuhlbradt]

The above illustrates exactly why 'Type' should be used with caution; in this case some use 'type' to convey primary/secondary/etc. vs others that use 'type' to convey simple/human/etc.

We forewent the use of 'Type' and chose to use 'Level' for those cases where the expected valid values were things like Primary, Secondary, Exploratory, Tertiary, etc. (can be used to qualify Endpoints and Objectives at the very least) because it is a little more descriptive and leaves the use of 'Type' open for another purpose. Semantically, Primary, Secondary, etc. can be considered as levels as they are rankings or positions denoting importance. We think 'Level' is better than 'Type' in this instance.

[EMuhlbradt]

In answer to the original question Are the Endpoint Levels aligned with the Objective Levels? ": No they are not. Any kind of endpoint can be associated with any kind of objective.

Ultimately though, the ICH M11 template uses the language Endpoint Level so we will continue using our existing semantics.

[dih-cdisc]

I also noted ICH E8, section 5.4

"A response variable is an attribute of interest that may be affected by the drug. The response variable may relate to pharmacokinetics, pharmacodynamics, efficacy, or safety of the drug, or to the use of the drug including, for example, in adherence to risk minimisation measures post-approval. Study endpoints are the response variables that are chosen to assess drug effects.

The primary endpoint should be capable of providing clinically relevant and convincing evidence related to the primary objective of the study (ICH E9). Secondary endpoints are either supportive measurements related to the primary objective or measurements of effects related to the secondary objectives. Exploratory endpoints are used to further explain or to support study findings or to explore new hypotheses for later research. The choice of endpoints should be meaningful for the intended population and may also take into account the views of patients. The definition of each study endpoint should be specific and include how and at what time points in a participant’s treatment course of the drug and follow-up it is ascertained.

Knowledge of the drug, along with the clinical context and purpose of a given study affect what response variables should be collected. For example, a proof-of-concept study of relatively short duration may employ a pharmacodynamic outcome rather than the outcome of primary interest (ICH E9). A larger study of longer duration could then be used to confirm a clinically meaningful effect on the outcome of primary interest. In other cases, such as a study where the safety profile of the drug is well characterised, the extent of safety data collection may be tailored to the objectives of the study."

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