{"id":6927,"date":"2026-01-13T11:11:21","date_gmt":"2026-01-13T10:11:21","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&#038;p=6927"},"modified":"2026-07-13T19:09:09","modified_gmt":"2026-07-13T17:09:09","slug":"study-discontinuation","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/study-discontinuation\/","title":{"rendered":"Study Discontinuation"},"content":{"rendered":"<p>The term study discontinuation covers two clearly distinct scenarios in clinical research: participant dropout and premature termination (early termination of the entire trial).<\/p>\n<p>In the case of participant dropout (subject withdrawal), an individual subject withdraws their consent. Under ICH-GCP E6(R2), this is possible at any time without giving reasons. CROs must embed strategies to minimise dropouts (e.g. patient engagement programmes) in the study protocol and must factor statistical power for expected discontinuation rates accordingly. Data already collected may continue to be used, provided the subject agrees.<\/p>\n<p>Premature termination refers to the early ending of the entire clinical trial by the sponsor, the competent authority, or the responsible investigator. Reasons for this can include safety concerns (an unexpectedly high SAE rate), lack of efficacy (as a result of a planned interim analysis by the DMC), serious GCP violations, or economic considerations.<\/p>\n<p>In the event of premature termination, the reporting obligations under ICH-GCP Section 4.12 (investigator&#8217;s obligations in the event of early termination) and Section 5.21 (sponsor&#8217;s obligations) must be observed from a regulatory perspective. In the EU, Regulation 536\/2014 (CTR) requires immediate notification of the competent authorities and Ethics Committees, as well as ensuring continued treatment and protection of enrolled participants.<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The term study discontinuation covers two clearly distinct scenarios in clinical research: participant dropout and premature termination (early termination of the entire trial). In the case of participant dropout (subject withdrawal), an individual subject withdraws their consent. Under ICH-GCP E6(R2), this is possible at any time without giving reasons. CROs must embed strategies to minimise [&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-6927","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\/6927","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\/6927\/revisions"}],"predecessor-version":[{"id":6928,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6927\/revisions\/6928"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6927"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6927"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}