Evidence map›Paper›PMID 40748422›Full record

ArticleAdvances in therapy2025

Five Data-Informed Principles for Advancing Inclusive Research in Clinical Trials: A Pharma Perspective.

Spencer L James, Shalini Hede, Altovise T Ewing-Crawford, Ruma Bhagat, Nicole Richie, Mitchell D'Rozario, Pierre Theodore, Bea Lavery, Sarah Bentouati, Assaf P Oron and 6 more

Abstract read
In one paragraph

Article in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Spencer L James *Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Shalini Hede *Genentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA. hede.shalini@gene.com.
Altovise T Ewing-CrawfordGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Ruma BhagatGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Nicole RichieGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Mitchell D'RozarioGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Pierre TheodoreGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Bea LaveryGenentech Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Sarah BentouatiF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Assaf P OronInstitute for Health Metrics and Evaluation at the University of Washington, 3980 15th Avenue NE, Seattle, WA, 98195, USA.
Catherine W GillespieInstitute for Health Metrics and Evaluation at the University of Washington, 3980 15th Avenue NE, Seattle, WA, 98195, USA.
Cleo A RyalsFlatiron Health, 233 Spring Street, New York, NY, 10013, USA.
Megan H Bair-MerrittBoston Medical Center, Office of Research and Sponsored Programs, 960 Massachusetts Avenue, 2nd Floor, 2545, Boston, MA, 02118, USA.
Johanna ChesleyBoston Medical Center, Office of Research and Sponsored Programs, 960 Massachusetts Avenue, 2nd Floor, 2545, Boston, MA, 02118, USA.
Evelyn JiaggeHenry Ford Health, 2799 W Grand Blvd, Detroit, MI, 48202, USA.
Bruno JolainF. Hoffmann-La Roche Ltd, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advancing inclusive research (AIR) in clinical trials requires frameworks and metrics for assessing real-world data and measuring population science. Because different factors drive health inequities and variables in measuring population science, relying on one metric for measuring progress may have limitations. Five principles (5Ps) are proposed for AIR globally that form the basis for a data-informed framework to measure and systematically define inclusive research to ensure rigor and benchmarking within organizations and across the broader sector. The first principle addresses biological, genetic, and population science considerations and their responsible use as data elements. The second principle pertains to using data to inform global region, country, and site placement, which includes geographical proportionality in trial enrollment, enabled access and commercialization strategies, and representative real-world demographic representation. The third principle is developing a data-informed and user-informed approach to end-to-end inclusive trial design. The fourth principle integrates patient-reported data collection standards and initiatives supporting complete and consistent clinical trial collection. The fifth principle enables trial access by demonstrating trustworthiness, improving patient navigation, and providing assistance programs. These 5Ps can be used as an end-to-end measurable framework using reference metrics, reproducible data, and methodologies for AIR in clinical development.Infographic available for this article.

Indexed as

Clinical Trials as TopicDrug IndustryResearch DesignData CollectionHumansAdvancing inclusive researchClinical trialsFrameworkPopulation science

Identifiers

PMID40748422
PMCPMC12474690

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.