ICH E10: Choice of Control Group and Related Issues in Clinical Trials¶
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2000). ICH E10: Choice of Control Group and Related Issues in Clinical Trials.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Domain-specific¶
- Standard of Care
- The structural commitment is that the meaningful baseline for both efficacy and accountability is dynamic and socially constructed: as evidence accumulates and treatments improve, the standard rises, so a practice that constituted adequate care last year may constitute negligence today, and a new treatment that once had only to beat placebo is increasingly judged against the updated standard, by showing non-inferiority to it or superiority over it, to earn regulatory and clinical acceptance
This sourceThe regulatory position that a new treatment tested against an active control may show efficacy by non-inferiority as well as by superiority. The choice between placebo and active controls, non-inferiority and superiority objectives, and the rule that placebo controls are generally inappropriate where available treatment prevents serious harm.
Supported in partVerified against the source
- The structural commitment is that the meaningful baseline for both efficacy and accountability is dynamic and socially constructed: as evidence accumulates and treatments improve, the standard rises, so a practice that constituted adequate care last year may constitute negligence today, and a new treatment that once had only to beat placebo is increasingly judged against the updated standard, by showing non-inferiority to it or superiority over it, to earn regulatory and clinical acceptance
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Read against the text for 1 of 1 citation: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Registry ID ref:fa56266b59b6 · see in the full table