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Journal of Biopharmaceutical Statistics Volume 26, 2016 - Issue 6: In Honor of Dr. Greg Campbell's Retirement
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Articles

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

Lilly Q. YueDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
,
Gregory CampbellDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Nelson LuDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Yunling XuDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
&
Bram ZuckermanDivision of Cardiovascular Devices, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Pages 1136-1145 | Published online: 01 Nov 2016

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Wei-Chen Chen, Nelson Lu, Chenguang Wang, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies. Journal of Biopharmaceutical Statistics 32:3, pages 400-413.
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Nelson Lu, Yunling Xu & Lilly Q. Yue. (2022) Rejoinder to Letter to the Editor—Selecting an Optimal Design for a Nonrandomized Comparative Study: A Commentary on “Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Utilizing Propensity Score Methodology for Medical Device Premarket Evaluation”. Statistics in Biopharmaceutical Research 14:2, pages 265-267.
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Guy Cafri, Paul Coplan, Shumin Zhang & Jesse A. Berlin. (2022) Selecting an Optimal Design for a Non-randomized Comparative Study: A Comment on “Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Utilizing Propensity Score Methodology for Medical Device Premarket Evaluation.”. Statistics in Biopharmaceutical Research 14:2, pages 262-264.
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Heng Li, Wei-Chen Chen, Nelson Lu, Changhong Song, Chenguang Wang, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches. Statistics in Biopharmaceutical Research 14:1, pages 87-91.
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Nelson Lu, Chenguang Wang, Wei-Chen Chen, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) 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 32:1, pages 158-169.
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Nelson Lu, Chenguang Wang, Wei-Chen Chen, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) Leverage multiple real-world data sources in single-arm medical device clinical studies. Journal of Biopharmaceutical Statistics 32:1, pages 107-123.
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Junjing Lin & Jianchang Lin. (2022) Incorporating propensity scores for evidence synthesis under bayesian framework: review and recommendations for clinical studies. Journal of Biopharmaceutical Statistics 32:1, pages 53-74.
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Rosanna Tarricone, Oriana Ciani, Aleksandra Torbica, Werner Brouwer, Georges Chaloutsos, Michael F Drummond, Nicolas Martelli, Ulf Persson, Reiner Leidl, Les Levin, Laura Sampietro-Colom & Rod S Taylor. (2020) Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective. Expert Review of Medical Devices 17:10, pages 993-1006.
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Chenguang Wang, Nelson Lu, Wei-Chen Chen, Heng Li, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2020) Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies. Journal of Biopharmaceutical Statistics 30:3, pages 495-507.
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Nelson Lu, Yunling Xu & Lilly Q. Yue. (2020) Some Considerations on Design and Analysis Plan on a Nonrandomized Comparative Study Using Propensity Score Methodology for Medical Device Premarket Evaluation. Statistics in Biopharmaceutical Research 12:2, pages 155-163.
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Chenguang Wang, Heng Li, Wei-Chen Chen, Nelson Lu, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2019) Propensity score-integrated power prior approach for incorporating real-world evidence in single-arm clinical studies. Journal of Biopharmaceutical Statistics 29:5, pages 731-748.
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Nelson Lu, Yunling Xu & Lilly Q. Yue. (2019) Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices. Journal of Biopharmaceutical Statistics 29:4, pages 580-591.
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Articles from other publishers (14)

Heng Li & Lilly Q. Yue. (2023) Propensity score‐based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation. Pharmaceutical Statistics 22:4, pages 721-738.
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Changhong Song, Heng Li, Wei‐Chen Chen, Nelson Lu, Ram Tiwari, Chenguang Wang, Yunling Xu & Lilly Q. Yue. (2023) Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score‐integrated composite likelihood approach. Pharmaceutical Statistics 22:3, pages 547-569.
Crossref
Weili He, Tae Hyun Jung, Hongwei Wang & Sai Dharmarajan. 2023. Real-World Evidence in Medical Product Development. Real-World Evidence in Medical Product Development 365 386 .
Heng Li & Lilly Q. Yue. 2023. Real-World Evidence in Medical Product Development. Real-World Evidence in Medical Product Development 167 192 .
W. Katherine Tan, Brian D. Segal, Melissa D. Curtis, Shrujal S. Baxi, William B. Capra, Elizabeth Garrett-Mayer, Brian P. Hobbs, David S. Hong, Rebecca A. Hubbard, Jiawen Zhu, Somnath Sarkar & Meghna Samant. (2022) Augmenting control arms with real-world data for cancer trials: Hybrid control arm methods and considerations. Contemporary Clinical Trials Communications 30, pages 101000.
Crossref
Heng Li, Chenguang Wang, Wei‐Chen Chen, Nelson Lu, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2022) Estimands in observational studies: Some considerations beyond ICH E9 ( R1 ) . Pharmaceutical Statistics 21:5, pages 835-844.
Crossref
Heng Li, Wei-Chen Chen, Chenguang Wang, Nelson Lu, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2021) Augmenting Both Arms of a Randomized Controlled Trial Using External Data: An Application of the Propensity Score-Integrated Approaches. Statistics in Biosciences 14:1, pages 79-89.
Crossref
Heng Li, Pamela E. Scott & Lilly Q. Yue. 2022. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1399 1416 .
Heng Li, Pamela E. Scott & Lilly Q. Yue. 2020. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1 18 .
Heng Li, Wei-Chen Chen, Nelson Lu, Chenguang Wang, Ram Tiwari, Yunling Xu & Lilly Q. Yue. (2020) Novel statistical approaches and applications in leveraging real-world data in regulatory clinical studies. Health Services and Outcomes Research Methodology 20:4, pages 237-246.
Crossref
Chenguang Wang & Gary L. Rosner. (2019) A Bayesian nonparametric causal inference model for synthesizing randomized clinical trial and real‐world evidence. Statistics in Medicine 38:14, pages 2573-2588.
Crossref
Yunling Xu, Nelson Lu, Lilly Yue & Ram Tiwari. (2019) A Study Design for Augmenting the Control Group in a Randomized Controlled Trial: A Quality Process for Interaction Among Stakeholders. Therapeutic Innovation & Regulatory Science, pages 216847901983038.
Crossref
Nelson Lu, Yunling Xu & Lilly Q. Yue. 2019. Contemporary Biostatistics with Biopharmaceutical Applications. Contemporary Biostatistics with Biopharmaceutical Applications 271 284 .
Gregory Campbell, Heng Li, Gene Pennello & Lilly Q. Yue. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 32 .

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