Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies
Medical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness of a medical device in a timely manner to keep up with technology flux. Bayesian methods provides an efficient approach to addressin...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2023-10-01
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| Series: | Medical Review |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/mr-2023-0026 |
| _version_ | 1797376037156290560 |
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| author | Cao Han Yao Chen Yuan Ying |
| author_facet | Cao Han Yao Chen Yuan Ying |
| author_sort | Cao Han |
| collection | DOAJ |
| description | Medical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness of a medical device in a timely manner to keep up with technology flux. Bayesian methods provides an efficient approach to addressing this challenge. In this article, we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting, including Bayesian adaptive design, Bayesian diagnostic design, Bayesian multiregional design, and Bayesian label expansion study. We illustrate these designs with medical devices approved by the US Food and Drug Administration (FDA). We also review several innovative Bayesian information borrowing methods, and briefly discuss the challenges and future directions of the Bayesian application in medical device trials. Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments. |
| first_indexed | 2024-03-08T19:32:54Z |
| format | Article |
| id | doaj.art-e38b807c582f4f1ca0d6a4aaa40c645a |
| institution | Directory Open Access Journal |
| issn | 2749-9642 |
| language | English |
| last_indexed | 2024-03-08T19:32:54Z |
| publishDate | 2023-10-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Medical Review |
| spelling | doaj.art-e38b807c582f4f1ca0d6a4aaa40c645a2023-12-26T07:40:39ZengDe GruyterMedical Review2749-96422023-10-013540842410.1515/mr-2023-0026Bayesian approach for design and analysis of medical device trials in the era of modern clinical studiesCao Han0Yao Chen1Yuan Ying2Department of Biostatistics, Peking University First Hospital, Beijing, ChinaDepartment of Biostatistics, Peking University First Hospital, Beijing, ChinaDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, USAMedical device technology develops rapidly, and the life cycle of a medical device is much shorter than drugs. It is necessary to evaluate the safety and effectiveness of a medical device in a timely manner to keep up with technology flux. Bayesian methods provides an efficient approach to addressing this challenge. In this article, we review the characteristics of the Bayesian approach and some Bayesian designs that were commonly used in medical device regulatory setting, including Bayesian adaptive design, Bayesian diagnostic design, Bayesian multiregional design, and Bayesian label expansion study. We illustrate these designs with medical devices approved by the US Food and Drug Administration (FDA). We also review several innovative Bayesian information borrowing methods, and briefly discuss the challenges and future directions of the Bayesian application in medical device trials. Our objective is to promote the use of the Bayesian approach to accelerate the development of innovative medical devices and their accessibility to patients for effective disease diagnoses and treatments.https://doi.org/10.1515/mr-2023-0026medical devicebayesian designbayesian information borrowing |
| spellingShingle | Cao Han Yao Chen Yuan Ying Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies Medical Review medical device bayesian design bayesian information borrowing |
| title | Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| title_full | Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| title_fullStr | Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| title_full_unstemmed | Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| title_short | Bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| title_sort | bayesian approach for design and analysis of medical device trials in the era of modern clinical studies |
| topic | medical device bayesian design bayesian information borrowing |
| url | https://doi.org/10.1515/mr-2023-0026 |
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