{"id":19748,"date":"2025-02-08T20:18:36","date_gmt":"2025-02-08T19:18:36","guid":{"rendered":"https:\/\/novustat.com\/statistics-glossary\/binary-outcome-superiority-trial.html"},"modified":"2026-08-28T10:03:06","modified_gmt":"2026-08-28T08:03:06","slug":"binary-outcome-superiority-trial","status":"publish","type":"page","link":"https:\/\/novustat.com\/en\/statistics-glossary\/binary-outcome-superiority-trial.html","title":{"rendered":"Binary Outcome Superiority Trial"},"content":{"rendered":"\t\t<div id=\"content\" role=\"main\" tabindex=\"-1\" data-elementor-type=\"wp-page\" data-elementor-id=\"19748\" class=\"elementor elementor-19748 elementor-19729\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-edd4832 e-flex e-con-boxed e-con e-parent\" data-id=\"edd4832\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-884fe64 e-con-full e-flex e-con e-child\" data-id=\"884fe64\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;none&quot;,&quot;animation_delay&quot;:200}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ee587f elementor-widget elementor-widget-html\" data-id=\"2ee587f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div id=\"novu-blog-branding\" class=\"novu-blog-branding\" aria-label=\"NOVUSTAT Statistik Glossar\">\n\n  <img class=\"novu-blog-branding__logo\" src=\"https:\/\/novustat.com\/wp-content\/uploads\/2026\/05\/Novustat_Logo_Blau1.png\" alt=\"NOVUSTAT\" loading=\"eager\" decoding=\"async\">\n\n  <span class=\"novu-blog-branding__divider\" aria-hidden=\"true\"><\/span>\n\n  <div class=\"novu-blog-branding__label\">\n    <span class=\"novu-blog-branding__label-main\">STATISTICS<\/span>\n    <span class=\"novu-blog-branding__label-accent\">GLOSSARY<\/span>\n  <\/div>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff6d51f elementor-widget elementor-widget-html\" data-id=\"ff6d51f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div class=\"novu-glossar-divider-row\" aria-label=\"Glossarbegriff Binary Outcome Superiority Trial\"><div class=\"novu-blog-divider\" aria-hidden=\"true\"><\/div><div class=\"novu-glossar-divider-row__context\"><span class=\"novu-glossar-divider-row__short-line\" aria-hidden=\"true\"><\/span><span class=\"novu-glossar-divider-row__title\">Superiority (binary)<\/span><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f1858c3 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f1858c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Binary Outcome Superiority Trial<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a826e1f elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a826e1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>A <em><a href=\"#online-tool\">Binary Outcome Superiority Trial<\/a><\/em> is a clinical trial method that aims to show that a treatment is superior to another treatment in terms of a binary outcome. A binary outcome refers to categories such as <strong>&#8220;success&#8221; vs. &#8220;failure&#8221; or &#8220;disease&#8221; vs. &#8220;health&#8221;.<\/strong> <\/p>\n\n\n<p><strong><strong>Novustat is your experienced partner and advises you on all aspects of statistics, from <a href=\"https:\/\/novustat.com\/en\/data-analysis.html\">data analysis<\/a> to the <a href=\"https:\/\/novustat.com\/statistische-beratung\/interpretation-statistik.html\">interpretation of results<\/a>, and helps you to gain maximum insight from your data sets. Contact us without obligation for further information! <\/strong><\/strong><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-13df359 elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"13df359\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd51183 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"bd51183\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Goal and concept<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7adcf88 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7adcf88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The main aim of such a study is to prove that the new treatment offers a statistically significant advantage over the existing treatment. In contrast to equivalence or non-inferiority studies, the focus here is on demonstrating superiority. This means that the results of the new treatment must be clearly better than those of the control group.  <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3017d4a elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3017d4a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7577c8d elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"7577c8d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Free online calculators for calculating sample size<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1aa568 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d1aa568\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>Use our online calculator to quickly and easily calculate the required sample size for your superiority study.<br\/>Calculator<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81d4262 elementor-widget elementor-widget-html\" data-id=\"81d4262\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div class=\"novu-glossary-calculator\" role=\"region\" aria-label=\"Online-Rechner zur Stichprobengr\u00f6ssenplanung\"><iframe src=\"https:\/\/novustat-1.shinyapps.io\/shiny-app-superiority\/\" width=\"100%\" height=\"600\"><\/iframe><\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9eb703 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d9eb703\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/novustat.com\/statistik-blog\/klinische-studien-aequivalenz-nichtunterlegenheit.html#ergebnistypen\">Back to other tools<\/a><\/div>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e001d1b elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"e001d1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5119563 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"5119563\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Calculating the sample size<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d1b035 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6d1b035\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>Calculating the sample size is crucial to ensuring that the study has sufficient statistical power to detect a genuine difference between the groups. This involves specifying an expected difference between the two groups that is considered clinically significant. Our specialized calculator helps you determine this difference and the required sample size.  <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dd110d8 elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"dd110d8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-df65325 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"df65325\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Application and requirements<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a361c41 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a361c41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>An example of a <em>binary outcome superiority trial<\/em> would be the comparison of a new drug treatment with an existing standard treatment for lowering blood pressure. If the aim is to significantly improve the cure rate of the new treatment, e.g. from <strong>60% to 75%<\/strong>, then the trial demonstrates superiority if this difference is statistically and clinically significant.<br\/>Conducting such a trial requires a clear hypothesis, careful definition of the primary endpoint and detailed planning to minimize bias or random error. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2b38b60 elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2b38b60\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-123e014 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"123e014\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Guidelines for calculating sample size for superiority trials with binary outcomes<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34be2e5 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"34be2e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The calculation of <a href=\"https:\/\/novustat.com\/statistik-blog\/tag\/stichprobenumfang\">the sample size<\/a> for a <em>binary-outcome superiority trial<\/em> is based on the expected difference between the groups, the significance level, and the statistical power. These parameters ensure that the study is robust enough to test the hypothesis of superiority. <br><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa0f23b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"fa0f23b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Significance level (alpha)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e29b738 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"e29b738\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The <strong>significance level<\/strong>, also known as <strong>alpha (\u03b1)<\/strong>, defines the probability of finding a difference even though none actually exists. Typically, an alpha of <strong>0.05<\/strong> is <strong>used<\/strong>, which corresponds to a<strong> 5% risk<\/strong> of a Type I error. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7446445 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"7446445\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Power (1-Beta)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd534a6 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"bd534a6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The <strong>power (1-\u03b2) <\/strong>indicates how likely it is that the study will detect a real difference between the groups. A typical power of <strong>80% <\/strong>means that the risk of a second type error <strong>(\u03b2)<\/strong> is<strong> 20%<\/strong>. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b50ac7c elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"b50ac7c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Percentage success rates in both groups<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8941316 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"8941316\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The <strong>success rate<\/strong> describes the proportion of patients in each group who achieve the desired result. In superiority studies, a significantly higher success rate is expected in the experimental group. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d0d6d05 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"d0d6d05\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Expected difference (d)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ef66344 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"ef66344\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The expected<strong> difference (d) <\/strong>indicates the minimum difference between the success rates of the groups that is considered clinically significant. For example, a value of <strong>15% (d = 15) <\/strong>means that the new treatment must improve the success rate by at least <strong>15% <\/strong>to be considered superior. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-97e9ba6 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"97e9ba6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Formula for calculation<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6bed431 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"6bed431\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n\n<p>The sample size is calculated using the following formula:<\/p>\n\n\n\n<div class=\"novu-trial-equation\">\\[n = \\frac{f(\\alpha, \\beta) \\cdot \\left[ \\pi_1 (100-\\pi_1) + \\pi_2 (100-\\pi_2) \\right]}{d^2}\\]<\/div>\n\n\n<p>Here, <strong>\u03c0<sub>1<\/sub> represents <\/strong>the success rate in the experimental group,<strong> \u03c0<sub>2<\/sub><\/strong> represents the success rate in the control group, and<strong> f(\u03b1, \u03b2)<\/strong> represents the Z-scores for the significance level and power. This formula ensures a precise calculation of the sample size and helps you achieve reliable results in your superiority study. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fa044d2 e-con-full novu-r15-faq-row e-flex e-con e-child\" data-id=\"fa044d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-7f2fb53 e-con-full novu-r15-faq-intro e-flex e-con e-child\" data-id=\"7f2fb53\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e4a8503 elementor-widget elementor-widget-spacer\" data-id=\"e4a8503\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-418d8ae elementor-widget elementor-widget-image\" data-id=\"418d8ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;none&quot;,&quot;_animation_delay&quot;:300}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/novustat.com\/wp-content\/uploads\/2026\/06\/Novustat_N_Logo_Weiss_Blau1.o.b.png\" title=\"Novustat_N_Logo_White_Blue1.o.b\" alt=\"Novustat_N_Logo_White_Blue1.o.b\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27a4527 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"27a4527\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-54f7e22 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"54f7e22\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently asked questions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba86ccc elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ba86ccc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7249f3b 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4.06 2h3a2 2 0 0 1 2 1.72c.12.91.33 1.8.63 2.65a2 2 0 0 1-.45 2.11L8 9.72a16 16 0 0 0 6.28 6.28l1.24-1.24a2 2 0 0 1 2.11-.45c.85.3 1.74.51 2.65.63A2 2 0 0 1 22 16.92z\"><\/path>\n          <\/svg>\n        <\/span>\n        <span>Call<\/span>\n      <\/button>\n\n      <div class=\"novu-hero-call-menu\">\n        <a href=\"tel:+4921199346512\">\n          <span class=\"novu-header-flag novu-header-flag--de\"><\/span>\n          <strong>+49 (0) 211 99346512<\/strong>\n        <\/a>\n\n        <a href=\"tel:+41788911111\">\n          <span class=\"novu-header-flag novu-header-flag--ch\"><\/span>\n          <strong>+41 (0) 78 89 11111<\/strong>\n        <\/a>\n\n        <a href=\"tel:+18885233685\">\n          <span class=\"novu-header-flag novu-header-flag--us\" style=\"background-image:url(https:\/\/novustat.com\/wp-content\/uploads\/2026\/10\/novustat-united-states-flag.png)!important\"><\/span>\n          <strong>+1 (888) 5233685<\/strong>\n        <\/a>\n      <\/div>\n    <\/div>\n\n  <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-69ad9d2 e-con-full e-flex e-con e-child\" data-id=\"69ad9d2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;animation&quot;:&quot;none&quot;,&quot;animation_delay&quot;:200,&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1b81cba elementor-widget elementor-widget-html\" data-id=\"1b81cba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div id=\"novu-faq-glossar-v1\" class=\"novu-faq-glossar-v1\">\n\n  <!-- =====================================================\n       FAQ 01\n       ===================================================== -->\n\n  <details class=\"novu-faq-glossar-v1__item\">\n\n    <summary class=\"novu-faq-glossar-v1__question\">\n\n      <span class=\"novu-faq-glossar-v1__question-text\">What is a binary outcome superiority trial?<\/span>\n\n      <span class=\"novu-faq-glossar-v1__icon\" aria-hidden=\"true\">\n        <svg viewBox=\"0 0 24 24\">\n          <path d=\"m7 10 5 5 5-5\"><\/path>\n        <\/svg>\n      <\/span>\n\n    <\/summary>\n\n    <div class=\"novu-faq-glossar-v1__answer\"><p>This study design tests whether a treatment performs statistically and clinically better than a comparator for a binary outcome.<\/p><\/div>\n\n  <\/details>\n\n\n  <!-- =====================================================\n       FAQ 02\n       ===================================================== -->\n\n  <details class=\"novu-faq-glossar-v1__item\">\n\n    <summary class=\"novu-faq-glossar-v1__question\">\n\n      <span class=\"novu-faq-glossar-v1__question-text\">Which binary outcomes are typical?<\/span>\n\n      <span class=\"novu-faq-glossar-v1__icon\" aria-hidden=\"true\">\n        <svg viewBox=\"0 0 24 24\">\n          <path d=\"m7 10 5 5 5-5\"><\/path>\n        <\/svg>\n      <\/span>\n\n    <\/summary>\n\n    <div class=\"novu-faq-glossar-v1__answer\"><p>Typical outcomes have two categories, such as success or failure, diseased or healthy, or survived or deceased.<\/p><\/div>\n\n  <\/details>\n\n\n  <!-- =====================================================\n       FAQ 03\n       ===================================================== -->\n\n  <details class=\"novu-faq-glossar-v1__item\">\n\n    <summary class=\"novu-faq-glossar-v1__question\">\n\n      <span class=\"novu-faq-glossar-v1__question-text\">What determines the sample size?<\/span>\n\n      <span class=\"novu-faq-glossar-v1__icon\" aria-hidden=\"true\">\n        <svg viewBox=\"0 0 24 24\">\n          <path d=\"m7 10 5 5 5-5\"><\/path>\n        <\/svg>\n      <\/span>\n\n    <\/summary>\n\n    <div class=\"novu-faq-glossar-v1__answer\"><p>It is mainly determined by expected success rates, the clinically relevant difference, significance level, and power.<\/p><\/div>\n\n  <\/details>\n\n\n  <!-- =====================================================\n       FAQ 04\n       ===================================================== -->\n\n  <details class=\"novu-faq-glossar-v1__item\">\n\n    <summary class=\"novu-faq-glossar-v1__question\">\n\n      <span class=\"novu-faq-glossar-v1__question-text\">What does the expected difference mean?<\/span>\n\n      <span class=\"novu-faq-glossar-v1__icon\" aria-hidden=\"true\">\n        <svg viewBox=\"0 0 24 24\">\n          <path d=\"m7 10 5 5 5-5\"><\/path>\n        <\/svg>\n      <\/span>\n\n    <\/summary>\n\n    <div class=\"novu-faq-glossar-v1__answer\"><p>It is the smallest difference between the groups considered clinically meaningful.<\/p><\/div>\n\n  <\/details>\n\n\n  <!-- =====================================================\n       FAQ 05\n       ===================================================== -->\n\n  <details class=\"novu-faq-glossar-v1__item\">\n\n    <summary class=\"novu-faq-glossar-v1__question\">\n\n      <span class=\"novu-faq-glossar-v1__question-text\">What prerequisites does a robust study require?<\/span>\n\n      <span class=\"novu-faq-glossar-v1__icon\" aria-hidden=\"true\">\n        <svg viewBox=\"0 0 24 24\">\n          <path d=\"m7 10 5 5 5-5\"><\/path>\n        <\/svg>\n      <\/span>\n\n    <\/summary>\n\n    <div class=\"novu-faq-glossar-v1__answer\"><p>A clear hypothesis, a clearly defined primary outcome, realistic effect assumptions, and a prespecified analysis plan are required.<\/p><\/div>\n\n  <\/details>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-04102ef elementor-hidden-mobile elementor-widget__width-initial elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"04102ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-91b7dae e-con-full e-flex e-con e-child\" data-id=\"91b7dae\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-cf26f4d e-con-full e-flex e-con e-child\" data-id=\"cf26f4d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c3b3aad elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"c3b3aad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Design superiority trials with binary outcomes on a sound basis.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-292cef8 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"292cef8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">A no-obligation initial assessment of your sample size and analysis plan.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a09ae3 elementor-widget__width-initial elementor-widget-mobile__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"2a09ae3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>NOVUSTAT supports you in defining clinically relevant effects, calculating power and sample size, and statistically analyzing binary outcomes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21b0373 elementor-widget-mobile__width-initial elementor-widget elementor-widget-heading\" data-id=\"21b0373\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Set realistic effect assumptions. Secure adequate power. Demonstrate superiority convincingly.<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9376b42 elementor-widget elementor-widget-html\" data-id=\"9376b42\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div id=\"novu-hero-buttons-only\">\n  <div class=\"novu-hero-buttons-row\">\n\n    <a class=\"novu-hero-btn novu-hero-btn-request\" href=\"\/en\/get-free-quote.html\">\n      <span class=\"novu-hero-btn-inner\">\n        <span class=\"novu-hero-icon\" aria-hidden=\"true\">\n          <svg viewBox=\"0 0 24 24\">\n            <path d=\"M22 2 11 13\"><\/path>\n            <path d=\"M22 2 15 22 11 13 2 9 22 2z\"><\/path>\n          <\/svg>\n        <\/span>\n        <span class=\"novu-hero-btn-text\">Request a Consultation<\/span>\n      <\/span>\n    <\/a>\n\n    <a class=\"novu-hero-btn novu-hero-btn-mail\" href=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#x69;&#x6e;&#x66;&#x6f;&#64;&#110;&#111;&#118;&#117;&#115;&#116;at&#46;com\">\n      <span class=\"novu-hero-btn-inner\">\n        <span class=\"novu-hero-icon\" aria-hidden=\"true\">\n          <svg viewBox=\"0 0 24 24\">\n            <rect x=\"3\" y=\"5\" width=\"18\" height=\"14\" rx=\"2\" ry=\"2\"><\/rect>\n            <path d=\"M3 7l9 6 9-6\"><\/path>\n          <\/svg>\n        <\/span>\n        <span class=\"novu-hero-btn-text\">Email Us<\/span>\n      <\/span>\n    <\/a>\n\n  <\/div>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e944e96 elementor-widget elementor-widget-html\" data-id=\"e944e96\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t\t<div\n  id=\"novu-cta-phone-row\"\n  class=\"novu-cta-phone-row\"\n  aria-label=\"NOVUSTAT Telefonnummern\"\n>\n\n  <div class=\"novu-cta-phone-row__item novu-cta-phone-row__item--de\">\n\n    <div\n      class=\"novu-cta-phone-row__flag novu-cta-phone-row__flag--de\"\n      role=\"img\"\n      aria-label=\"Deutschland\"\n    ><\/div>\n\n    <a\n      class=\"novu-cta-phone-row__number\"\n      href=\"tel:+4921199346512\"\n      aria-label=\"NOVUSTAT Deutschland anrufen unter +49 0 211 99346512\"\n    >\n      +49 (0) 211 99346512\n    <\/a>\n\n  <\/div>\n\n\n  <div class=\"novu-cta-phone-row__item novu-cta-phone-row__item--ch\">\n\n    <div\n      class=\"novu-cta-phone-row__flag novu-cta-phone-row__flag--ch\"\n      role=\"img\"\n      aria-label=\"Schweiz\"\n    ><\/div>\n\n    <a\n      class=\"novu-cta-phone-row__number\"\n      href=\"tel:+41788911111\"\n      aria-label=\"NOVUSTAT Schweiz anrufen unter +41 0 78 89 11111\"\n    >\n      +41 (0) 78 89 11111\n    <\/a>\n\n  <\/div>\n\n\n  <div class=\"novu-cta-phone-row__item novu-cta-phone-row__item--us\">\n\n    <div\n      class=\"novu-cta-phone-row__flag\" style=\"background:none;display:flex;align-items:center;justify-content:center;font-size:24px;line-height:1;\"\n      role=\"img\"\n      aria-label=\"United States\"\n    ><img class=\"novu-glossary-us-flag-png novu-us-flag\" src=\"https:\/\/novustat.com\/wp-content\/uploads\/2026\/10\/novustat-united-states-flag.png\" alt=\"United States\" width=\"36\" height=\"24\" decoding=\"async\"><\/div>\n\n    <a\n      class=\"novu-cta-phone-row__number\"\n      href=\"tel:+18885233685\"\n      aria-label=\"Call NOVUSTAT USA at +1 888 5233685\"\n    >\n      +1 (888) 5233685\n    <\/a>\n\n  <\/div>\n\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d13a74 novu-gdpr-badge-widget elementor-widget elementor-widget-image\" data-id=\"5d13a74\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"1000\" src=\"https:\/\/novustat.com\/wp-content\/uploads\/2026\/06\/DSGVO-konform-Badge-NOVUSTAT_ergebnis-e1781089815189.webp\" class=\"attachment-full size-full wp-image-37907\" alt=\"GDPR-compliant trust element on the NOVUSTAT website\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>A Binary Outcome Superiority Trial is a clinical trial method that aims to show that a treatment is superior to another treatment in terms of a binary outcome. A binary outcome refers to categories such as &#8220;success&#8221; vs. &#8220;failure&#8221; or &#8220;disease&#8221; vs. &#8220;health&#8221;. Novustat is your experienced partner and advises you on all aspects of [&hellip;]<\/p>\n","protected":false},"author":17,"featured_media":0,"parent":19740,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-glossar.php","meta":{"_acf_changed":false,"_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-19748","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Binary Outcome Superiority Trial - Statistik Service<\/title>\n<meta name=\"description\" content=\"Would you like to demonstrate the effectiveness of a new treatment? 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