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Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development

OBJECTIVE AND BACKGROUND: The clinical trials community has been hesitant to adopt Bayesian statistical methods, which are often more flexible and efficient with more naturally interpretable results than frequentist methods. We aimed to identify self-reported barriers to implementing Bayesian method...

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Autores principales: Clark, Jennifer, Muhlemann, Natalia, Natanegara, Fanni, Hartley, Andrew, Wenkert, Deborah, Wang, Fei, Harrell, Frank E., Bray, Ross
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720547/
https://www.ncbi.nlm.nih.gov/pubmed/34978048
http://dx.doi.org/10.1007/s43441-021-00357-x
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author Clark, Jennifer
Muhlemann, Natalia
Natanegara, Fanni
Hartley, Andrew
Wenkert, Deborah
Wang, Fei
Harrell, Frank E.
Bray, Ross
author_facet Clark, Jennifer
Muhlemann, Natalia
Natanegara, Fanni
Hartley, Andrew
Wenkert, Deborah
Wang, Fei
Harrell, Frank E.
Bray, Ross
collection PubMed
description OBJECTIVE AND BACKGROUND: The clinical trials community has been hesitant to adopt Bayesian statistical methods, which are often more flexible and efficient with more naturally interpretable results than frequentist methods. We aimed to identify self-reported barriers to implementing Bayesian methods and preferences for becoming comfortable with them. METHODS: We developed a 22-question survey submitted to medical researchers (non-statisticians) from industry, academia, and regulatory agencies. Question areas included demographics, experience, comfort levels with Bayesian analyses, perceived barriers to these analyses, and preferences for increasing familiarity with Bayesian methods. RESULTS: Of the 323 respondents, most were affiliated with pharmaceutical companies (33.4%), clinical research organizations (29.7%), and regulatory agencies (18.6%). The rest represented academia, medical practice, or other. Over 56% of respondents expressed little to no comfort in interpreting Bayesian analyses. “Insufficient knowledge of Bayesian approaches” was ranked the most important perceived barrier to implementing Bayesian methods by a plurality (48%). Of the approaches listed, in-person training was the most preferred for gaining comfort with Bayesian methods. CONCLUSIONS: Based on these survey results, we recommend that introductory level training on Bayesian statistics be presented in an in-person workshop that could also be broadcast online with live Q&A. Other approaches such as online training or collaborative projects may be better suited for higher-level trainings where instructors may assume a baseline understanding of Bayesian statistics. Increased coverage of Bayesian methods at medical conferences and medical school trainings would help improve comfort and overcome the substantial knowledge barriers medical researchers face when implementing these methods. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00357-x.
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spelling pubmed-87205472022-01-03 Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development Clark, Jennifer Muhlemann, Natalia Natanegara, Fanni Hartley, Andrew Wenkert, Deborah Wang, Fei Harrell, Frank E. Bray, Ross Ther Innov Regul Sci Analytical Report OBJECTIVE AND BACKGROUND: The clinical trials community has been hesitant to adopt Bayesian statistical methods, which are often more flexible and efficient with more naturally interpretable results than frequentist methods. We aimed to identify self-reported barriers to implementing Bayesian methods and preferences for becoming comfortable with them. METHODS: We developed a 22-question survey submitted to medical researchers (non-statisticians) from industry, academia, and regulatory agencies. Question areas included demographics, experience, comfort levels with Bayesian analyses, perceived barriers to these analyses, and preferences for increasing familiarity with Bayesian methods. RESULTS: Of the 323 respondents, most were affiliated with pharmaceutical companies (33.4%), clinical research organizations (29.7%), and regulatory agencies (18.6%). The rest represented academia, medical practice, or other. Over 56% of respondents expressed little to no comfort in interpreting Bayesian analyses. “Insufficient knowledge of Bayesian approaches” was ranked the most important perceived barrier to implementing Bayesian methods by a plurality (48%). Of the approaches listed, in-person training was the most preferred for gaining comfort with Bayesian methods. CONCLUSIONS: Based on these survey results, we recommend that introductory level training on Bayesian statistics be presented in an in-person workshop that could also be broadcast online with live Q&A. Other approaches such as online training or collaborative projects may be better suited for higher-level trainings where instructors may assume a baseline understanding of Bayesian statistics. Increased coverage of Bayesian methods at medical conferences and medical school trainings would help improve comfort and overcome the substantial knowledge barriers medical researchers face when implementing these methods. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-021-00357-x. Springer International Publishing 2022-01-03 2023 /pmc/articles/PMC8720547/ /pubmed/34978048 http://dx.doi.org/10.1007/s43441-021-00357-x Text en © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Analytical Report
Clark, Jennifer
Muhlemann, Natalia
Natanegara, Fanni
Hartley, Andrew
Wenkert, Deborah
Wang, Fei
Harrell, Frank E.
Bray, Ross
Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title_full Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title_fullStr Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title_full_unstemmed Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title_short Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development
title_sort why are not there more bayesian clinical trials? perceived barriers and educational preferences among medical researchers involved in drug development
topic Analytical Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8720547/
https://www.ncbi.nlm.nih.gov/pubmed/34978048
http://dx.doi.org/10.1007/s43441-021-00357-x
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