Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs¶
U.S. Food and Drug Administration. (2020). Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry.
Cited by¶
2 citations across 2 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Extrapolation Beyond Sampled Regime
- First, pharmacological dosing: the calibrated apparatus is a drug's efficacy-and-safety profile with its dosing guidance; the sampled regime is the clinical-trial cohort defined by inclusion criteria — typically adults of a certain age range, excluding pregnancy, paediatrics, severe comorbidity, and polypharmacy.
This sourceTreats trial eligibility (inclusion/exclusion) criteria as defining the studied population — typically excluding pregnancy, pediatrics, severe comorbidity, and polypharmacy — and warns that narrow criteria limit generalizability to the populations that will ultimately receive the drug.
- First, pharmacological dosing: the calibrated apparatus is a drug's efficacy-and-safety profile with its dosing guidance; the sampled regime is the clinical-trial cohort defined by inclusion criteria — typically adults of a certain age range, excluding pregnancy, paediatrics, severe comorbidity, and polypharmacy.
- Intersection
- and to clinical-trial eligibility (each inclusion criterion's cohort, the joint cohort, the empty case meaning "no enrollable patient").
This sourceDocuments that the eligible cohort is the intersection of inclusion/exclusion criteria and that overly restrictive criteria can leave too few or no enrollable patients.
- and to clinical-trial eligibility (each inclusion criterion's cohort, the joint cohort, the empty case meaning "no enrollable patient").
Verification¶
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Does it back the claim? Not recorded. Neither this nor any other of the 2 citations of this work carries a recorded support check.
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Links previously used in the corpus¶
Before the registry existed this work was also linked 1 other way.
Registry ID ref:f57971a908c4 · see in the full table