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). Choice of Control Group and Related Issues in Clinical Trials.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Mechanisms¶
- External Control Justification Memo
- The memo is what a regulator reads to decide whether the borrowed comparison can carry weight, guided by long-standing expectations for external controls.
This sourceSets regulatory expectations for when an external control may be credible, including comparability, data quality, and minimization of bias.
- The memo is what a regulator reads to decide whether the borrowed comparison can carry weight, guided by long-standing expectations for external controls.
- Standard-Care Comparator Specification
- The specification also notes that a study powered against this stronger comparator needs a larger sample
This sourceExplains that active-control trials often require large sample sizes because the relevant treatment difference or noninferiority margin is small.
- The specification also notes that a study powered against this stronger comparator needs a larger sample
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? Not recorded. Neither this nor any other of the 2 citations of this work carries a recorded support check.
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:fb104f58e037 · see in the full table