ArticleLearning health systems2026
Empirical research related to the ethics of pragmatic clinical trials: A scoping review.
Article in Learning health systems, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
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.
Who cites it
2 citing papers in PubMed.
- Systematic review of approaches to informed consent in recent high-impact clinical trials.Journal of clinical and translational science · 2026Article
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Background: Pragmatic clinical trials (PCTs) offer insights into real-world intervention effectiveness, but they may involve challenging ethical issues. Empirical ethics research may inform deliberations about them. Methods: We conducted a scoping review of empirical ethics research related to PCTs. This involved searching in PubMed and Embase, charting findings, and analyzing themes to identify trends and gaps. Results: Eighty-two publications were included, which examined a vast number of issues encompassing 22 themes. The five most prominent were: consent/disclosure; risk assessment; trust and transparency; burdens, barriers, and costs; and engagement. Written consent is often impractical, prompting interest in opt-out or general notification approaches. Challenges in risk assessment include variability in defining minimal risk, thereby complicating regulatory determinations for the appropriateness of particular participant protections and communicating research risks. Trust-building practices, such as result-sharing and data-use disclosure, can foster confidence. Stakeholder engagement can address logistical barriers, improve recruitment, and align research with participant needs. Time, financial, and regulatory burdens are significant obstacles to implementing PCTs. Conclusion: There has been progress in understanding many ethical issues encountered in PCTs, including appropriately navigating alternatives to obtaining written informed consent, trust-building, and the operational role of stakeholder engagement. However, critical gaps remain, with research concentrated in Western contexts and reliant on surveys and hypothetical scenarios, limiting generalizability and real-world insights. Addressing these gaps with geographically inclusive studies, innovative methods, and nested empirical work will be important for more comprehensively understanding the ethical issues in PCTs and developing appropriate approaches to mitigating them.
Indexed as
Identifiers
What OpenQuestion holds
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.