Evidence map›Paper›PMID 37900353›Full record

ReviewJournal of clinical and translational science2023

A causal roadmap for generating high-quality real-world evidence.

Lauren E Dang, Susan Gruber, Hana Lee, Issa J Dahabreh, Elizabeth A Stuart, Brian D Williamson, Richard Wyss, Iván Díaz, Debashis Ghosh, Emre Kıcıman and 16 more

Open access · goldAbstract readReview
In one paragraph

Review in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
20.3field-weighted citation impact, top 1% of its field
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

35 citing papers in PubMed, 60 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2025
    Article
  13. Review
  14. Article
  15. Article
  16. Toward New Directions in Human Biology: A Roadmap for Anthropological Causal Inference With Observational Data.American journal of human biology : the official journal of the Human Biology Council · 2025
    Article
  17. Article
  18. Article
  19. Review
  20. 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

26 authors at 19 institutions in 3 countries.

Lauren E DangDepartment of Biostatistics, University of California, Berkeley, CA, USA.ORCID https://orcid.org/0000-0002-2967-0855
Susan GruberTL Revolution, Cambridge, MA, USA.
Hana LeeOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Issa J DahabrehCAUSALab, Department of Epidemiology and Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Elizabeth A StuartDepartment of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Brian D WilliamsonBiostatistics Division, Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.ORCID https://orcid.org/0000-0002-7024-548X
Richard WyssDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Iván DíazDivision of Biostatistics, Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA.ORCID https://orcid.org/0000-0001-9056-2047
Debashis GhoshDepartment of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Emre KıcımanMicrosoft Research, Redmond, WA, USA.
Demissie AlemayehuGlobal Biometrics and Data Management, Pfizer Inc., New York, NY, USA.
Katherine L HoffmanDepartment of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
Carla Y VossenSyneos Health Clinical Solutions, Amsterdam, The Netherlands.
Raymond A HumlSyneos Health Clinical Solutions, Morrisville, NC, USA.ORCID https://orcid.org/0000-0003-3899-0217
Henrik RavnNovo Nordisk, Søborg, Denmark.
Kajsa KvistNovo Nordisk, Søborg, Denmark.
Richard PratleyAdventHealth Translational Research Institute, Orlando, FL, USA.
Mei-Chiung ShihCooperative Studies Program Coordinating Center, VA Palo Alto Health Care System, Palo Alto, CA, USA.
Gene PennelloDivision of Imaging Diagnostics and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.ORCID https://orcid.org/0000-0002-9779-1165
David MartinGlobal Real World Evidence Group, Moderna, Cambridge, MA, USA.
Salina P WaddyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Charles E BarrGraticule Inc., Newton, MA, USA.
Mouna AkachaNovartis Pharma AG, Basel, Switzerland.
John B BuseDivision of Endocrinology, Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.ORCID https://orcid.org/0000-0002-9723-3876
Mark van der LaanDepartment of Biostatistics, University of California, Berkeley, CA, USA.
Maya PetersenDepartment of Biostatistics, University of California, Berkeley, CA, USA.
University of California, Berkeley · USNovo Nordisk (Denmark) · DKUnited States Food and Drug Administration · USBrigham and Women's Hospital · USColorado School of Public Health · USColumbia University · USHarvard University · USJohns Hopkins University · USKaiser Permanente Washington Health Research Institute · USMicrosoft (United States) · USModerna Therapeutics (United States) · USNational Center for Advancing Translational Sciences · USNew York University · USNovartis (Switzerland) · CHPfizer (United States) · USSyneos Health (United States) · USTranslational Research Institute for Metabolism and Diabetes · USUniversity of North Carolina at Chapel Hill · USVA Palo Alto Health Care System · US

Funding

Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI P Darrell Neufer · 2020 to 2026
$11.0M
NIDDK NIH HHS P30 DK124723
6 · The paper itself

Abstract

Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The

Indexed as

Causal inferenceestimandsmachine learningreal-world evidencesensitivity analysissimulations

Identifiers

PMID37900353
PMCPMC10603361
OpenAlexW4386961764

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.