ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials

International Council for Harmonisation. (1998). ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical Trials: Statistical Principles for Clinical Trials.

Type

Standard

Intellectual base

Reference work

Year

1998

Link

https://database.ich.org/sites/default/files/E8_Guideline.pdf

Cited from

computer_science, philosophy

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.

• Sandboxing
  • Clinical drug trials: phase-I/II trials run a candidate intervention in delimited populations under heavy observation, with stopping rules and explicit graduation criteria — the trial is the sandbox.

    This sourceDefines the phased structure of clinical trials, including phase-I/II bounded populations, monitoring, and stopping rules that gate advancement.

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Links previously used in the corpus

Before the registry existed this work was also linked 1 other way.

• https://database.ich.org/sites/default/files/E9_Guideline.pdf ×1

Registry ID ref:a1dc5ba9d24b · see in the full table