{"title":"Improved confidence estimation for the binomial proportion with applications to clinical studies.","authors":"Mo Yang, Xiaoning Kang, Borek Puza","doi":"10.1080/10543406.2023.2183506","DOIUrl":null,"url":null,"abstract":"<p><p>In this paper, we establish a frequentist framework that incorporates all confidence sets with guaranteed frequentist coverage probability for the binomial proportion, where different confidence sets are completely characterized by their tail functions. Based on measures of precision in the form of interval length, probability of false coverage, and a new evaluation criterion utilizing prior information, we construct the optimal confidence set for the binomial proportion. The newly proposed methodology is applied to clinical studies. It is shown that confidence intervals obtained via the tail functions are often better than prevailing confidence intervals in view of precision.</p>","PeriodicalId":54870,"journal":{"name":"Journal of Biopharmaceutical Statistics","volume":" ","pages":"717-731"},"PeriodicalIF":1.3000,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Biopharmaceutical Statistics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10543406.2023.2183506","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/3/16 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
In this paper, we establish a frequentist framework that incorporates all confidence sets with guaranteed frequentist coverage probability for the binomial proportion, where different confidence sets are completely characterized by their tail functions. Based on measures of precision in the form of interval length, probability of false coverage, and a new evaluation criterion utilizing prior information, we construct the optimal confidence set for the binomial proportion. The newly proposed methodology is applied to clinical studies. It is shown that confidence intervals obtained via the tail functions are often better than prevailing confidence intervals in view of precision.
期刊介绍:
The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers:
Drug, device, and biological research and development;
Drug screening and drug design;
Assessment of pharmacological activity;
Pharmaceutical formulation and scale-up;
Preclinical safety assessment;
Bioavailability, bioequivalence, and pharmacokinetics;
Phase, I, II, and III clinical development including complex innovative designs;
Premarket approval assessment of clinical safety;
Postmarketing surveillance;
Big data and artificial intelligence and applications.