{"id":6966,"date":"2026-04-01T11:16:45","date_gmt":"2026-04-01T09:16:45","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6966"},"modified":"2026-07-13T19:09:32","modified_gmt":"2026-07-13T17:09:32","slug":"per-protocol-analysis","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/per-protocol-analysis\/","title":{"rendered":"Per-Protocol Analysis"},"content":{"rendered":"<p>Per-protocol analysis (PP analysis, also known as efficacy analysis or valid-case analysis) is a secondary or supplementary analysis strategy in clinical trials in which only those participants who fully and correctly complied with the study protocol are evaluated. This generally includes: receipt of the intended treatment (at least a defined compliance threshold), no serious protocol violations, and complete collection of the primary endpoint.<\/p>\n<p>The PP analysis estimates the efficacy of a treatment under optimal conditions (efficacy), whereas the Intention-to-Treat analysis (ITT) measures effectiveness under real-world conditions. In superiority trials, the ITT analysis is primary; the PP analysis serves as a sensitivity analysis. In equivalence and non-inferiority trials, the PP analysis is equally weighted or primary, since protocol violations here can systematically lead to a convergence of the groups (conservative bias in favour of the null hypothesis).<\/p>\n<p>The definition of the PP population must be established in the Statistical Analysis Plan (SAP) before database lock, in order to avoid post-hoc selection bias. For CROs, careful documentation of protocol violations (protocol deviations) is a prerequisite for a valid PP analysis. Regulatory reference: ICH E9, CPMP\/EWP\/908\/99 (Non-Inferiority Studies).<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Per-protocol analysis (PP analysis, also known as efficacy analysis or valid-case analysis) is a secondary or supplementary analysis strategy in clinical trials in which only those participants who fully and correctly complied with the study protocol are evaluated. This generally includes: receipt of the intended treatment (at least a defined compliance threshold), no serious protocol [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[],"class_list":["post-6966","glossary","type-glossary","status-publish","hentry"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":1,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6966\/revisions"}],"predecessor-version":[{"id":6968,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6966\/revisions\/6968"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6966"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}