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Although such cut-offs are conventional, they may conflict with beneficence by increasing exposure to ineffective or harmful treatments through false positives, or by withholding beneficial therapies through false negatives. Simply lowering the threshold to values like 0.005 reduces false positives but raises false negatives and does not resolve reproducibility concerns. Context-dependent, flexible alpha levels informed by design, sample size, prior evidence, and effect size can improve both scientific validity and ethical integrity.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/uncertain-use-of-a-fixed-p-value-significance-threshold-in-randomized-clinical-trials/451959/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/uncertain-use-of-a-fixed-p-value-significance-threshold-in-randomized-clinical-trials/451959.png","ImageObject",300,407,{"name":92,"@type":93},"Kurz","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why is using a fixed p value significance threshold ethically problematic in randomized clinical trials?","Question",{"text":112,"@type":113},"A fixed threshold can increase the risk of both false-positive and false-negative results, which may expose patients to ineffective or harmful treatments or deny them beneficial therapies. These outcomes create tension with the ethical principle of beneficence to minimize harm and maximize benefit.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Does lowering the significance threshold (e.g., from 0.05 to 0.005) solve the reproducibility crisis?",{"text":117,"@type":113},"Lowering the threshold can reduce false positives but increases false negatives, and the article states it does not resolve the reproducibility crisis. Evidence suggests changing to another fixed value is insufficient.",{"name":119,"@type":110,"acceptedAnswer":120},"What approach does the article recommend for significance thresholds in RCTs?",{"text":121,"@type":113},"It recommends context-dependent, flexible alpha levels that balance type I and type II errors. The choice should consider study design, sample size, prior evidence, and effect size rather than a universal fixed cut-off.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},451959,1790897508,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":14,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":24,"preview_page_count":4},2336478945635,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","Habibzadeh Trials (2026)27:8  \n[https://doi.org/10.1186/s13063-026-09438-4](https://doi.org/10.1186/s13063-026-09438-4)  \nTrials  \n COMMENTARY Open Access  \nUncertain use of a fixed p value significance   threshold in randomized clinical trials  \nFarrokh Habibzadeh 1*  \nAbstract  \nThe continued use of a fixed p value significance threshold, such as p \u003C 0. 05, in randomized clinical trials has long been debated. Although such thresholds are conventional, they may not always align with the ethical principle of beneficence, which emphasizes minimizing harm and maximizing benefit. Reliance on a single, fixed α level increases the risk of both false-positive (type I) and false-negative (type II) error rates, thereby either exposing patients to ineffective or harmful treatments or withholding beneficial therapies. While lowering the threshold to values like 0.005 may reduce the false-positive rate, it also increases the false-negative rate and does not resolve the reproducibility crisis. Similar to diagnostic testing, the selection of a significance threshold should be context-dependent, influenced by study design, sample size, prior evidence, and effect size, among other things. Employing a flexible α level that balances type I and type II errors may enhance both scientific validity and ethical integrity. Thus, rigid adherence to fixed α levels, no matter how stringent, may be methodologically limiting and ethically questionable.  \nKeywords Randomized controlled trials, Ethics, Reproducibility of results, Biostatistics  \nDear Editor,  \nThe use of a fixed p value significance threshold (in statistical parlance, the α level), such as p \u003C 0.05, which was originally proposed by Ronald A. Fisher in 1925 [1], for the data analysis and interpretation of results of randomized clinical trials (RCTs) may raise important ethical and methodological issues. Approving an ineffective or potentially harmful treatment due to a false-positive result (type I error) exposes future patients to unnecessary risk. Conversely, failing to identify a truly effective treatment due to a false-negative result (type II error) deprives future patients of the advantages they might otherwise receive. Both scenarios highlight tensions with the ethical principle of beneficence, which obliges researchers to maximize benefit and minimize harm.  \n*Correspondence:  \nFarrokh Habibzadeh [farrokh.habibzadeh@gmail.com](farrokh.habibzadeh@gmail.com)  \n1 Independent Research Consultant, Shiraz, Iran  \nOver the years, the p value has turned into an unofficial guardian of the science determining what counts as scientific “truth.” Yet many scholars have argued against uncritical reliance on the conventional α level of 0.05 [2, 3]. Proposals to lower the significance threshold from 0.05 to more stringent values, such as 0.005, aim to reduce false-positive results but risk increasing false negatives [3, 4]. This trade-off lies at the heart of the reproducibility crisis [5, 6]. Indeed, evidence suggests that simply lowering the significance threshold to another fixed value does not solve the problem [7].  \nStatistical hypothesis testing shares important features with diagnostic testing [4]. Just as diagnostic tests require context-specific cut-offs to be clinically meaningful and applicable, significance thresholds in RCTs should not be universal. Many researchers believe that the α level should also be adapted to the context of the study—its design, sample size, prior evidence, and effect size of interest, among other things [4, 8, 9].  \nFrom both scientific and ethical perspectives, it is preferable to minimize the combined impact of type I and type II errors. This requires adopting flexible α levels  \n© The Author(s) 2026. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriat","cbCainZxWo9WEjXp","https://ap.wps.com/l/cbCainZxWo9WEjXp","pdf",564943,"English","# Abstract\n# Commentary\n## Letter to the Editor\n## Statistical and ethical considerations\n## Conclusion\n# Declarations","[{\"question\":\"Why is using a fixed p value significance threshold ethically problematic in randomized clinical trials?\",\"answer\":\"A fixed threshold can increase the risk of both false-positive and false-negative results, which may expose patients to ineffective or harmful treatments or deny them beneficial therapies. These outcomes create tension with the ethical principle of beneficence to minimize harm and maximize benefit.\"},{\"question\":\"Does lowering the significance threshold (e.g., from 0.05 to 0.005) solve the reproducibility crisis?\",\"answer\":\"Lowering the threshold can reduce false positives but increases false negatives, and the article states it does not resolve the reproducibility crisis. Evidence suggests changing to another fixed value is insufficient.\"},{\"question\":\"What approach does the article recommend for significance thresholds in RCTs?\",\"answer\":\"It recommends context-dependent, flexible alpha levels that balance type I and type II errors. The choice should consider study design, sample size, prior evidence, and effect size rather than a universal fixed cut-off.\"}]","Uncertain use of a fixed p value significance threshold in randomized clinical trials | PDF",1790736224]