ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials¶
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1998). ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials: Statistical Principles for Clinical Trials.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Holdout Set
- Educational assessment: exam items reserved from teaching materials so they measure learning rather than rehearsal; retired items; norming samples held out of item development. Pharmaceutical development: confirmatory trials run only after exploratory trials have generated the hypothesis; locked-database analysis; pre-specified secondary analyses.
This sourceCodifies the exploratory/confirmatory distinction, pre-specified hypotheses, the locked analysis plan, and the rule that post-hoc subgroup findings are not confirmatory — the regulated form of evidence segregation.
- Educational assessment: exam items reserved from teaching materials so they measure learning rather than rehearsal; retired items; norming samples held out of item development. Pharmaceutical development: confirmatory trials run only after exploratory trials have generated the hypothesis; locked-database analysis; pre-specified secondary analyses.
Domain-specific¶
- Carryover Effect
- The concept applies across crossover clinical trials (where it is a major concern in ICH E9 regulatory guidance
Supported in partVerified against a saved copy of the source
“their results. The chief difficulty concerns carryover, that is, the residual influence of treatments”
- The concept applies across crossover clinical trials (where it is a major concern in ICH E9 regulatory guidance
Verification¶
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