Evidence map›Paper›PMID 35088432›Full record

ReviewBritish journal of clinical pharmacology2022

Clinical trial diversity: An opportunity for improved insight into the determinants of variability in drug response.

Annette S Gross, Anya C Harry, Christine S Clifton, Oscar Della Pasqua

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Inequities in enrollment across clinical trial phases and the need for a Spanish perspective.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Scoping review of oncology clinical trials nursing: Roles, competencies, and evolving practice in cancer research.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026
    Article
  11. Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026
    Article
  12. Article
  13. The READI European project: Enhancing inclusivity in clinical research.European journal of clinical investigation · 2026
    Article
  14. Article
  15. Article
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  19. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Annette S GrossClinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, NSW, Australia.ORCID 0000-0001-9567-0127
Anya C HarryGlobal Demographics & Diversity, Global Clinical Sciences and Delivery, GlaxoSmithKline R&D, Upper Providence, PA, USA.
Christine S CliftonClinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Sydney, NSW, Australia.
Oscar Della PasquaClinical Pharmacology Modelling & Simulation, GlaxoSmithKline R&D, Brentford, UK.ORCID 0000-0002-6211-1430

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Although the number of countries participating in pivotal trials submitted to enable drug registration has nearly doubled over the past 25 years, there has not been a substantial increase in the diversity of clinical trial populations. In parallel, our understanding of factors that influence medicine response and variability has continued to evolve. The notion of intrinsic and extrinsic sources of variability has been embedded into different regulatory guidelines, including the recent guideline on the importance of enhancing the diversity of clinical trial populations. In addition to presenting the clinical and scientific reasons for ensuring that clinical trial populations represent the demographics of patient populations, this overview outlines the efforts of regulatory agencies, patient advocacy groups and clinical researchers to attain this goal through strategies to meet representation in recruitment targets and broaden eligibility criteria. Despite these efforts, challenges to participation in clinical trials remain, and certain groups continue to be underrepresented in development programmes. These challenges are amplified when the representativeness of specific groups may vary across countries and regions in a global clinical programme. Whilst enhanced trial diversity is a critical step towards ensuring that results will be representative of patient populations, a concerted effort is required to characterise further the factors influencing interindividual and regional differences in response for global populations. Quantitative clinical pharmacology principles should be applied to allow extrapolation of data across groups or regions as well as provide insight into the effect of patient-specific characteristics on a medicine's dose rationale and efficacy and safety profiles.

Indexed as

Pharmacology, ClinicalHumansagediversityethnicityrecruitmentsex

Identifiers

PMID35088432
PMCPMC9306578

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.