Evidence map›Paper›PMID 34978048›Full record

ArticleTherapeutic innovation & regulatory science2023

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

Medical Outreach Subteam of the Drug Information Association Bayesian Scientific Working Group, Jennifer Clark, Natalia Muhlemann, Fanni Natanegara, Andrew Hartley, Deborah Wenkert, Fei Wang, Frank E Harrell, Ross Bray

Open access · bronzeAbstract read
In one paragraph

Article in Therapeutic innovation & regulatory science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  13. A Tutorial on Modern Bayesian Methods in Clinical Trials.Therapeutic innovation & regulatory science · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Medical Outreach Subteam of the Drug Information Association Bayesian Scientific Working Group
Jennifer ClarkFood and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Jennifer.Clark@fda.hhs.gov.ORCID 0000-0002-5404-3087
Natalia MuhlemannCytel, Cambridge, MA, USA.
Fanni NatanegaraEli Lilly and Company, Indianapolis, IN, USA.
Andrew HartleyPPD, Inc., Wilmington, NC, USA.
Deborah WenkertWenkert & Young, LLC, Thousand Oaks, CA, USA.
Fei WangBoehringer Ingelheim, Ingelheim Am Rhein, Germany.
Frank E HarrellDepartment of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.
Ross BrayEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USBoehringer Ingelheim (Germany) · DECytel (United States) · USUnited States Food and Drug Administration · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OBJECTIVE AND

backgroundThe 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.

methodsWe 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.

resultsOf 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.

conclusionsBased 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.

Indexed as

Drug DevelopmentHealth PersonnelBayes TheoremEducational StatusHumansSurveys and QuestionnairesBayesian barriersBayesian educationBayesian methodsClinical trialsMedical school training

Identifiers

PMID34978048
PMCPMC8720547
OpenAlexW4206542691

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.