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Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-07, Vol.22 (4), p.721-738

2023

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Real-World Evidence — What Is It and What Can It Tell Us?

The New England journal of medicine, 2016-12, Vol.375 (23), p.2293-2297

2016

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Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies

Journal of biopharmaceutical statistics, 2019-09, Vol.29 (5), p.731-748

2019

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Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices

Journal of biopharmaceutical statistics, 2019-07, Vol.29 (4), p.580-591

2019

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Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data

Journal of biopharmaceutical statistics, 2020-05, Vol.30 (3), p.508-520

2020

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Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies

Journal of biopharmaceutical statistics, 2020-05, Vol.30 (3), p.495-507

2020

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Designing Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities

Journal of biopharmaceutical statistics, 2014-01, Vol.24 (5), p.994-1010

2014

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Statistical innovations in the medical device world sparked by the FDA

Journal of biopharmaceutical statistics, 2016-01, Vol.26 (1), p.3-16

2016

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Leveraging real‐world evidence for determining performance goals for medical device studies

Statistics in medicine, 2021-12, Vol.40 (29), p.6577-6589

2021

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Leverage multiple real-world data sources in single-arm medical device clinical studies

Journal of biopharmaceutical statistics, 2022-01, Vol.32 (1), p.107-123

2022

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Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources

Journal of biopharmaceutical statistics, 2022-01, Vol.32 (1), p.158-169

2022

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A propensity score-integrated approach for leveraging external data in a randomized controlled trial with time-to-event endpoints

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2024-03, Vol.23 (5), p.645-661

2024

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Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies

Journal of biopharmaceutical statistics, 2022-05, Vol.32 (3), p.400-413

2022

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Comparison between surrogate indexes of insulin sensitivity and resistance and hyperinsulinemic euglycemic clamp estimates in mice

American journal of physiology: endocrinology and metabolism, 2008-02, Vol.294 (2), p.E261-E270

2008

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Utilizing national and international registries to enhance pre-market medical device regulatory evaluation

Journal of biopharmaceutical statistics, 2016-11, Vol.26 (6), p.1136-1145

2016

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Regulatory Considerations in the Design of Comparative Observational Studies Using Propensity Scores

Journal of biopharmaceutical statistics, 2012-11, Vol.22 (6), p.1272-1279

Yue, Lilly Q.

2012

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Estimands in observational studies: Some considerations beyond ICH E9 (R1)

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-09, Vol.21 (5), p.835-844

2022

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Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study

Journal of biopharmaceutical statistics, 2021-05, Vol.31 (3), p.375-390

2021

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Propensity score‐incorporated adaptive design approaches when incorporating real‐world data

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2024-03, Vol.23 (2), p.204-218

2024

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A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders

Therapeutic innovation & regulatory science, 2020-03, Vol.54 (2), p.269-274

2020

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Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2023-05, Vol.22 (3), p.547-569

2023

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Novel statistical approaches and applications in leveraging real-world data in regulatory clinical studies

Health services and outcomes research methodology, 2020-12, Vol.20 (4), p.237-246

2020

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A conversation with Dr. Greg Campbell

Journal of biopharmaceutical statistics, 2016-11, Vol.26 (6), p.1007-1019

2016

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Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies

Journal of biopharmaceutical statistics, 2007-01, Vol.17 (1), p.1-13

Yue, Lilly Q.

2007

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Augmenting Both Arms of a Randomized Controlled Trial Using External Data: An Application of the Propensity Score-Integrated Approaches

Statistics in biosciences, 2022, Vol.14 (1), p.79-89

2022

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Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation

Real-World Evidence — What Is It and What Can It Tell Us?

Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies

Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices

Propensity score-integrated composite likelihood approach for augmenting the control arm of a randomized controlled trial by incorporating real-world data

Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies

Designing Premarket Observational Comparative Studies Using Existing Data as Controls: Challenges and Opportunities

Statistical innovations in the medical device world sparked by the FDA

Leveraging real‐world evidence for determining performance goals for medical device studies

Leverage multiple real-world data sources in single-arm medical device clinical studies

Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources

A propensity score-integrated approach for leveraging external data in a randomized controlled trial with time-to-event endpoints

Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies

Comparison between surrogate indexes of insulin sensitivity and resistance and hyperinsulinemic euglycemic clamp estimates in mice

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation

Regulatory Considerations in the Design of Comparative Observational Studies Using Propensity Scores

Estimands in observational studies: Some considerations beyond ICH E9 (R1)

Evaluation of diagnostic tests for low prevalence diseases: a statistical approach for leveraging real-world data to accelerate the study

Propensity score‐incorporated adaptive design approaches when incorporating real‐world data

A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders

Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach

Novel statistical approaches and applications in leveraging real-world data in regulatory clinical studies

A conversation with Dr. Greg Campbell

Statistical and Regulatory Issues with the Application of Propensity Score Analysis to Nonrandomized Medical Device Clinical Studies

Augmenting Both Arms of a Randomized Controlled Trial Using External Data: An Application of the Propensity Score-Integrated Approaches

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