Evidence map›Paper›PMID 36792750›Full record

ReviewNature reviews. Drug discovery2023

Application of Bayesian approaches in drug development: starting a virtuous cycle.

Stephen J Ruberg, Francois Beckers, Rob Hemmings, Peter Honig, Telba Irony, Lisa LaVange, Grazyna Lieberman, James Mayne, Richard Moscicki

Abstract readReview
In one paragraph

Review in Nature reviews. Drug discovery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

48 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  8. Review
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  13. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
    Review
  14. Article
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  17. A Guide to Bayesian Optimization in Bioprocess Engineering.Biotechnology and bioengineering · 2026
    Review
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  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Stephen J RubergAnalytix Thinking, Indianapolis, IN, USA. AnalytixThinking@gmail.com.ORCID http://orcid.org/0000-0001-8439-0015
Francois BeckersMerck KGaA, Darmstadt, Germany.
Rob HemmingsConsilium Salmonson and Hemmings, Woking, UK.
Peter HonigIndependent Advisor, Collegeville, PA, USA.
Telba IronyJanssen Pharmaceutical Companies of J & J, Titusville, NJ, USA.
Lisa LaVangeUniversity of North Carolina, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0001-6755-6925
Grazyna LiebermanGenentech, South San Francisco, CA, USA.
James MaynePharmaceutical Research and Manufacturers of America, Washington, DC, USA.
Richard MoscickiPharmaceutical Research and Manufacturers of America, Washington, DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pharmaceutical industry and its global regulators have routinely used frequentist statistical methods, such as null hypothesis significance testing and p values, for evaluation and approval of new treatments. The clinical drug development process, however, with its accumulation of data over time, can be well suited for the use of Bayesian statistical approaches that explicitly incorporate existing data into clinical trial design, analysis and decision-making. Such approaches, if used appropriately, have the potential to substantially reduce the time and cost of bringing innovative medicines to patients, as well as to reduce the exposure of patients in clinical trials to ineffective or unsafe treatment regimens. Nevertheless, despite advances in Bayesian methodology, the availability of the necessary computational power and growing amounts of relevant existing data that could be used, Bayesian methods remain underused in the clinical development and regulatory review of new therapies. Here, we highlight the value of Bayesian methods in drug development, discuss barriers to their application and recommend approaches to address them. Our aim is to engage stakeholders in the process of considering when the use of existing data is appropriate and how Bayesian methods can be implemented more routinely as an effective tool for doing so.

Indexed as

Drug IndustryResearch DesignBayes TheoremHumans

Identifiers

PMID36792750
PMCPMC9931171

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.