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.

Type

Report

Intellectual base

Grey literature

Year

2020

Link

https://www.fda.gov/media/127712/download

Cited from

mathematics, statistics_experimental_design

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.

• 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.

Verification

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Links previously used in the corpus

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

• https://www.federalregister.gov/documents/2020/11/10/2020-24881/enhancing-the-diversity-of-clinical-trial-populations-eligibility-criteria-enrollment-practices-and ×1

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