{"id":6253,"date":"2026-04-01T11:17:17","date_gmt":"2026-04-01T09:17:17","guid":{"rendered":"https:\/\/mediconomics.com\/glossar\/comparative-preparation\/"},"modified":"2026-07-13T19:08:36","modified_gmt":"2026-07-13T17:08:36","slug":"comparative-preparation","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/comparative-preparation\/","title":{"rendered":"Comparator Drug"},"content":{"rendered":"<p>The Comparator Drug (also comparator product) is, in a controlled clinical trial, the product against which the investigational medicinal product (IMP) is compared. It may be a placebo (a dummy medication without active substance), an active comparator (an already authorised medicinal product), or a standard therapy.<\/p>\n<p>The choice of comparator is decisive for the study design and regulatory acceptance: placebo-controlled trials are optimal for measuring efficacy but are ethically permissible only where no effective standard therapy exists. Actively controlled trials compare the investigational medicinal product with a standard therapy (e.g. in non-inferiority trials) and are frequently preferred from a regulatory perspective.<\/p>\n<p>If the Comparator Drug is an authorised medicinal product, it must be specially procured, documented and, where necessary, packaged\/masked (overencapsulation, double-dummy technique) for use in the clinical trial to ensure blinding. A Certificate of Analysis (CoA) is required. For CROs, comparator management (procurement, storage, blinding, distribution, cold chain) is a logistically demanding and quality-critical task. Regulatory reference: ICH-GCP E6(R2); EU GMP Annex 13.<\/p>\n<p><a href=\"https:\/\/mediconomics.com\/en\/glossary\/\">Back to overview<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Comparator Drug (also comparator product) is, in a controlled clinical trial, the product against which the investigational medicinal product (IMP) is compared. It may be a placebo (a dummy medication without active substance), an active comparator (an already authorised medicinal product), or a standard therapy. The choice of comparator is decisive for the study [&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-6253","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\/6253","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\/6253\/revisions"}],"predecessor-version":[{"id":6982,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/6253\/revisions\/6982"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=6253"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=6253"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}