Research graph
References from Considerations for the Integration of Clinical Trials and Real‐World Data. Local targets link to admitted publications; unresolved targets remain external evidence.
The emergence of the randomized, controlled trial
10.1056/nejmp1604635 · 2016 · External reference
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Real‐world evidence for regulatory decision‐making: guidance from around the world
10.1016/j.clinthera.2022.01.012 · 2022 · External reference
Real‐world evidence for regulatory decision‐making: updated guidance from around the world
10.3389/fmed.2023.1236462 · 2023 · External reference
Methods for integrating trials and non‐experimental data to examine treatment effect heterogeneity
10.1214/23-sts890 · 2023 · External reference
Data integration in causal inference
10.1002/wics.1581 · 2023 · External reference
Causal inference methods for combining randomized trials and observational studies: a review
10.1214/23-sts889 · 2024 · External reference
Generalizing evidence from randomized clinical trials to target populations: the ACTG 320 trial
10.1093/aje/kwq084 · 2010 · External reference
Extending inferences from a randomized trial to a target population: IJ Dahabreh, MA Hernán
10.1007/s10654-019-00533-2 · 2019 · External reference
Real‐world evidence to support regulatory decision‐making for medicines: considerations for external control arms
10.1002/pds.4975 · 2020 · External reference
Linking clinical trial participants to their US real‐world data through tokenization: a practical guide
10.1016/j.conctc.2024.101354 · 2024 · External reference
Case study of semaglutide and cardiovascular outcomes: an application of the causal roadmap to a hybrid design for augmenting an RCT control arm with real‐world data
10.1017/cts.2023.656 · 2023 · External reference
Causal models and learning from data: integrating causal modeling and statistical estimation
10.1097/ede.0000000000000078 · 2014 · External reference
Efficacy and safety of degludec versus glargine in type 2 diabetes
10.1056/nejmoa1615692 · 2017 · External reference
Increasing the efficiency of randomized trial estimates via linear adjustment for a prognostic score
10.1515/ijb-2021-0072 · 2022 · External reference
Modern causal inference approaches to improve power for subgroup analysis in randomized controlled trials
10.1002/sim.70436 · 2026 · External reference
Design of DEVOTE (trial comparing cardiovascular safety of insulin degludec vs. insulin glargine in patients with type 2 diabetes at high risk of cardiovascular events)—DEVOTE 1
10.1016/j.ahj.2016.06.004 · 2016 · External reference
Beyond randomized clinical trials: use of external controls
10.1002/cpt.1723 · 2020 · External reference
Testing for treatment effect twice using internal and external controls in clinical trials
10.1515/jci-2022-0018 · 2023 · External reference
Using RWE research to extend clinical trials in diabetes: an example with implications for the future
10.1111/dom.14021 · 2020 · External reference
Transportability of causal and statistical relations: a formal approach
2011 · External reference
Transporting: what is it and how do you do it?
10.1007/s40471-025-00374-6 · 2025 · External reference
Marketing authorization applications made to the European medicines agency in 2018–2019: what was the contribution of real‐world evidence?
10.1002/cpt.2461 · 2022 · External reference
Doubly robust omnibus sensitivity analysis of externally controlled trials with intercurrent events
10.1093/biomtc/ujaf047 · 2025 · External reference
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Using big data to emulate a target trial when a randomized trial is not available
10.1093/aje/kwv254 · 2016 · External reference
External control arms in oncology: current use and future directions
10.1016/j.annonc.2021.12.015 · 2022 · External reference
Improving trial generalizability using observational studies
10.1111/biom.13609 · 2023 · External reference
Long‐term effect estimation when combining clinical trial and observational follow‐up datasets
10.1080/01621459.2025.2526703 · 2026 · External reference
10.1017/cbo9780511803161
10.1017/cbo9780511803161 · 2009 · External reference
Matching within a hybrid RCT/RWD: framework on associated causal estimands
10.1080/10543406.2022.2105346 · 2023 · External reference
Super learner
2007 · External reference
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A framework for methodological choice and evidence assessment for studies using external comparators from real‐world data
10.1007/s40264-020-00944-1 · 2020 · External reference
Methods for external control groups for single‐arm trials or long‐term uncontrolled extensions to randomized clinical trials
10.1002/pds.5141 · 2020 · External reference
Regulatory and HTA considerations for development of real‐world data‐derived external controls
10.1002/cpt.2913 · 2023 · External reference
Data challenges for externally controlled trials
10.2196/43484 · 2023 · External reference
A comparative study of clinical trial and real‐world data in patients with diabetic kidney disease
10.1038/s41598-024-51938-3 · 2024 · External reference
Proof of concept and design of an externally controlled trial for patients with gastro‐entero‐pancreatic neuroendocrine carcinomas based on the randomized phase II BEVANEC trial
10.1016/j.ejca.2025.115450 · 2025 · External reference
On the use of non‐concurrent controls in platform trials: a scoping review
10.1186/s13063-023-07398-7 · 2023 · External reference
Causal inference under multiple versions of treatment
10.1515/jci-2012-0002 · 2013 · External reference
Beyond the cox hazard ratio: a targeted learning approach to survival analysis in a cardiovascular outcome trial application
10.1080/19466315.2023.2173644 · 2023 · External reference
Estimation of causal effect in integrating randomized clinical trial and observational data—an example application to cardiovascular outcome trial
10.1016/j.cct.2021.106492 · 2021 · External reference
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A selective review of negative control methods in epidemiology
10.1007/s40471-020-00243-4 · 2020 · External reference
Experiment‐selector cross‐validated targeted maximum likelihood estimator for hybrid RCT‐external data studies
10.1515/jci-2024-0041 · 2025 · External reference
Sensitivity analysis for causal inference under unmeasured confounding and measurement error problems
10.1515/ijb-2013-0004 · 2013 · External reference
Evaluating and improving real‐world evidence with targeted learning
10.1186/s12874-023-01998-2 · 2023 · External reference
Commentary on ‘nonparametric identification is not enough, but randomized controlled trials are’: statistical considerations for generating reliable evidence across a spectrum of studies that increasingly involve real‐world elements
10.1353/obs.2025.a956842 · 2025 · External reference
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A review of generalizability and transportability
10.1146/annurev-statistics-042522-103837 · 2023 · External reference
Use of historical control data for assessing treatment effects in clinical trials
10.1002/pst.1589 · 2014 · External reference
Revisit of test‐then‐pool methods and some practical considerations
10.1002/pst.2009 · 2020 · External reference
Design of randomized controlled confirmatory trials using historical control data to augment sample size for concurrent controls
10.1080/10543406.2018.1559853 · 2019 · External reference
The power prior: theory and applications
10.1002/sim.6728 · 2015 · External reference
Matching‐assisted power prior for incorporating real‐world data in randomized clinical trial analysis
10.1002/sim.10342 · 2025 · External reference
Commensurate priors for incorporating historical information in clinical trials using general and generalized linear models
10.1214/12-ba722 · 2012 · External reference
Summarizing historical information on controls in clinical trials
10.1177/1740774509356002 · 2010 · External reference
Adaptive‐TMLE for the average treatment effect based on randomized controlled trial augmented with real‐world data
10.1515/jci-2024-0025 · 2026 · External reference
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