Rationale

On January 12, 2026, the U.S. Food and Drug Administration (FDA) issued a landmark draft guidance, “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products,” jointly released by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This is the first comprehensive FDA guidance addressing the use of Bayesian methods for primary inference in pivotal clinical trials of drugs and biologics.

The draft guidance articulates clear regulatory expectations for Bayesian trial designs—including prior specification, success criteria based on posterior probabilities, simulation-based operating characteristics, and computational transparency—and signals a paradigm shift in how statistical evidence may be generated and evaluated in regulatory submissions. It represents a historic opportunity for the statistical community to advance both methodology and practice in this area.

In response, the New England Journal of Statistics in Data Science (NEJSDS) is pleased to announce a special issue dedicated to Bayesian methodology in clinical trials for drugs and biologics.

Scope

We invite original research articles, methodological developments, review papers, and case studies on topics including, but not limited to:

• Bayesian trial designs for Phase I–III clinical trials (dose-finding, adaptive, platform, seamless)
• Prior specification and elicitation strategies for regulatory settings
• Information borrowing from historical, external, and real-world data sources
• Bayesian approaches to multiplicity, interim monitoring, and sequential decision-making
• Calibration of Bayesian designs to frequentist and Bayesian operating characteristics
• Computational methods and software for Bayesian clinical trial design and analysis
• Case studies of Bayesian submissions to regulatory agencies
• Bayesian methods for rare diseases, pediatric extrapolation, and precision medicine
• Other topics related to Bayesian methodology in clinical trials for drugs and biologics

Timeline

• Submission deadline: August 1, 2026
• First-round decisions: October 2026
• Expected publication: Early 2027

Submission

Manuscripts should be submitted through the NEJSDS online submission system at: https://journal.nestat.org/

Please indicate in the cover letter that the submission is intended for the special issue on Bayesian Methodology in Clinical Trials for Drugs and Biologics.

Editors: Cancer Section of NEJSDS

• Yuan Ji, PhD — Department of Public Health Sciences, University of Chicago
• Ying Lu, PhD — Department of Biomedical Data Science, Stanford University

For inquiries, please contact: yji@bsd.uchicago.edu