Evidence map›Paper›PMID 42415784›Full record

ArticleFrontiers in medicine2026

Data-driven trial design: use of target trial emulation to evaluate eligibility criteria in asthma and COPD.

Solomon B Makgoeng, Margaret Gamalo, Leo J Russo, Vivek Pradhan, Abhishek Bhattacharjee, Nandini Bhosale

2 registry-linked trialsAbstract read
In one paragraph

Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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.

NCT02414854 phase3completednot on this map

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

TypeinterventionalSponsorSanofiRan2015 to 2017Enrolled1,902ConditionsAsthmaArmsDupilumab, Placebo, Inhaled corticosteroid (ICS) therapy, Albuterol/Salbutamol, Levalbuterol/Levosalbutamol
NCT03930732 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation

TypeinterventionalSponsorSanofiRan2019 to 2023Enrolled939ConditionsChronic Obstructive Pulmonary DiseaseArmsDupilumab SAR231893, Inhaled Corticosteroid, Inhaled Long-Acting Beta Agonist, Inhaled Long-Acting Muscarinic Antagonist, Placebo
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

6 authors.

Solomon B MakgoengPfizer Inc, Collegeville, PA, United States.
Margaret GamaloPfizer Inc, Collegeville, PA, United States.
Leo J RussoPfizer Inc, Collegeville, PA, United States.
Vivek PradhanPfizer Inc, Cambridge, MA, United States.
Abhishek BhattacharjeePfizer Healthcare India Pvt. Ltd, Chennai, Tamil Nadu, India.
Nandini BhosalePfizer Healthcare India Pvt. Ltd, Chennai, Tamil Nadu, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Clinical trial eligibility criteria are crucial to ensuring valid estimation of therapeutic treatment effects and robust measurement of safety. However, highly restrictive criteria have a negative impact on study generalizability and patient accrual. Methods: Following the target trial emulation framework, we applied a modified Trial Pathfinder approach to emulate dupilumab trials for chronic obstructive pulmonary disease (COPD; NCT03930732) and asthma (NCT02414854), using Optum Market Clarity electronic health records and annualized exacerbation rate ratio (AERR) as the primary endpoint. We attempted to match the rigor of the original trial effect estimates using doubly robust, augmented inverse probability-weighted estimates for AERR and corresponding confidence intervals using the bootstrap method. We computed Results: We identified dupilumab new-user cohorts for COPD ( Conclusion: Our findings demonstrate the use of trial emulation and Trial Pathfinder for data-driven identification of eligibility criteria for relaxation or removal in non-oncology therapeutic areas. Thorough assessment for unmeasured confounding is essential for credible causal inference. Lastly, the comparison of sample characteristics provided valuable insights into how data-driven eligibility criteria enhance the generalizability of clinical trials.

Indexed as

asthmachronic obstructive pulmonary diseasedupilumabeligibility criteriamodified Trial Pathfinderreal-world datatrial emulation

Identifiers

PMID42415784
PMCPMC13337763

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Registered trials

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.