Evidence map›Paper›PMID 40857072›Full record

ReviewClinical and translational science2025

How Clinical Pharmacology Can Support Clinical Trial Diversity and Inclusion.

Michael Z Liao, Aarti Sawant, Brian Corrigan, Sebastian Haertter, Yasuto Otsubo, Islam R Younis, Sreeneeranj Kasichayanula, Rashmi Mehta

Abstract readReview
In one paragraph

Review in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Diversity in Translation: Equal Is Greater Than.Clinical and translational science · 2026
    Article
  2. Review
  3. Review
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

8 authors.

Michael Z LiaoGenentech, Inc., South San Francisco, California, USA.ORCID 0000-0003-0684-0150
Aarti SawantClinical Pharmacology and Pharmacometrics, AstraZeneca, Waltham, Massachusetts, USA.ORCID 0000-0003-3749-5222
Brian CorriganGlobal Product Development, Pfizer Inc, Groton, Connecticut, USA.
Sebastian HaertterClinical Pharmacology, Boehringer- Ingelheim Pharma, Ingelheim, Germany.ORCID 0000-0003-3569-5626
Yasuto OtsuboPharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Islam R YounisQuantitative Pharmacology and Pharmacometrics, Merck and Co. Inc, Rahway, New Jersey, USA.ORCID 0000-0001-9000-0431
Sreeneeranj KasichayanulaGilead Sciences, Foster City, California, USA.
Rashmi MehtaClinical Pharmacology Modeling and Simulation, GSK PLC, Durham, North Carolina, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Enrolling diverse populations during early clinical trial development and planning for diversity plans could be challenging. In 2024, the Diversity and Inclusion Clinical Pharmacology Leadership Group Working Group (D&I CPLG WG) from The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) collaborated with the American Society for Clinical Pharmacology and Therapeutics (ASCPT) to develop a pre-conference session with speakers from industry, regulators, and IQ to utilize clinical pharmacology tools and implement the guidance on diversity plans toward improving the participation of under-represented populations in clinical trials. The pre-conference was well attended by industry, academia, as well as regulators and led to robust presentations and panel discussions through speaker sessions and case studies. The three state-of-the-art lectures and five case studies address key issues concerning the inclusion of underrepresented populations, as well as clinical pharmacology strategies to support the assessment of benefits and risks. The sessions offered insights into clinical pharmacology strategies for evaluating the effects of age, ethnic differences, organ impairment, drug metabolism, transporters, and translational pharmacogenetics approaches in clinical trials. They also highlighted the application of model-informed drug development (MIDD)-based extrapolation to bridge Phase III results to targeted subpopulations, thereby enhancing the efficiency of drug development. Additionally, the diverse formats of this pre-conference, including a hands-on workshop, breakout sessions, and panel discussions, provided an opportunity for the audience to discuss the practicalities of incorporating these principles in drug development settings. This conference reinforced that achieving diversity in clinical trials is a multifaceted challenge that requires sustained efforts across the clinical research ecosystem, guided by a commitment to equity and community engagement. As clinical pharmacologists, we are uniquely positioned to lead this transformation, ensuring future therapies are safe, effective, and equitable for all.

Indexed as

Clinical Trials as TopicCultural DiversityPatient SelectionPharmacology, ClinicalDrug DevelopmentHumansdiversity and inclusiongeriatricsorgan impairmentpharmacogeneticprecision medicinerace and ethnicity

Identifiers

PMID40857072
PMCPMC12379548

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.