Healthcare and pharmaceutical research present some of the most consequential applications of Bayesian statistics. From designing adaptive clinical trials that can respond to accumulating evidence to modeling the spread of infectious diseases, Bayesian methods offer a principled framework for decision-making under uncertainty. The ISBA Section on Biostatistics and Pharmaceutical Statistics serves as the primary forum for researchers and practitioners working at this critical intersection.
Scope and Relevance
The section's scope encompasses a wide range of applications in the health sciences. Clinical trial design is a central focus, as Bayesian approaches to trial design—including adaptive designs, basket trials, and Bayesian decision-theoretic frameworks—have gained increasing acceptance from regulatory agencies such as the FDA. Pharmacokinetic and pharmacodynamic modeling, meta-analysis, survival analysis, and diagnostic test evaluation are all areas where Bayesian methods bring unique advantages.
The U.S. Food and Drug Administration (FDA) has issued guidance documents encouraging the use of Bayesian methods in medical device trials and has accepted Bayesian designs for pharmaceutical trials. This regulatory openness has been supported by the research and advocacy of section members, who have worked to demonstrate the rigor and reliability of Bayesian approaches in regulatory settings.
Key Contributions
Members of the section have made landmark contributions to Bayesian biostatistics. Work on Bayesian adaptive trial designs by researchers such as Donald Berry has transformed how clinical trials are conducted, allowing for interim analyses and design modifications that can reduce the time and cost of drug development while maintaining statistical rigor. Bayesian approaches to borrowing historical information—through power priors, commensurate priors, and meta-analytic frameworks—allow clinical trialists to incorporate evidence from previous studies, reducing sample sizes and accelerating the development of new therapies.
Activities
The section organizes workshops and invited sessions at ISBA World Meetings, JSM, and specialized conferences in biostatistics and pharmaceutical statistics. These events bring together academic researchers, industry statisticians, and regulatory scientists, fostering dialogue that is essential for the practical adoption of Bayesian methods in healthcare. The section also sponsors webinars and short courses on topics such as Bayesian clinical trial design, Bayesian survival analysis, and the use of Bayesian methods in health technology assessment.
"In medicine, every decision is made under uncertainty. Bayesian statistics provides the natural language for expressing, quantifying, and acting on that uncertainty."— Donald Berry
Future Directions
As healthcare generates ever-larger volumes of data—from electronic health records, genomics, and wearable devices—the section is increasingly focused on scalable Bayesian methods for high-dimensional biomedical data, Bayesian approaches to causal inference in observational studies, and the integration of real-world evidence into regulatory decision-making.