{"id":1460,"date":"2019-08-08T12:57:00","date_gmt":"2019-08-08T16:57:00","guid":{"rendered":"https:\/\/clariowebstg.wpengine.com\/?post_type=case_study&#038;p=1460"},"modified":"2025-07-01T18:01:17","modified_gmt":"2025-07-01T22:01:17","slug":"training-program-reduces-placebo-effect-by-more-than-50-in-epro-study","status":"publish","type":"case_study","link":"https:\/\/clario.com\/resources\/case-studies\/training-program-reduces-placebo-effect-by-more-than-50-in-epro-study\/","title":{"rendered":"Training program reduces placebo effect by more than 50% in ePRO study"},"content":{"rendered":"<div class=\"clario-anchor-navigation sticky-top \">\n  <div class=\"container\">\n    <div class=\"row\">\n      <a href=\"#situation\" class=\"button active nav-link col-auto\">Situation<\/a><a href=\"#solution\" class=\"button nav-link col-auto\">Solution<\/a><a href=\"#impact\" class=\"button nav-link col-auto\">Impact<\/a>            <button class=\"control arrow closed\" aria-label=\"Toggle\"><\/button>\n    <\/div>\n  <\/div>\n<\/div>\n\n<script type=\"text\/javascript\">\n  jQuery(window).on(\"load\", function() {\n    Clario.AnchorNavigation.run();\n  });\n<\/script>\n\n\n<div class=\"clario-section\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"situation\">Situation<\/h2>\n\n\n\n<p>Migraine is a common and debilitating neurological disease, affecting 39 million people in the United States alone. It has a considerable impact on patients&#8217; lives, with 90% of people unable to work or function normally during an attack*<em>.<\/em> Current treatments, such as triptans, are not effective as headaches can reoccur within 24 hours after taking migraine medication \u2014 and also produce cardiovascular contraindications and warnings. High placebo response rates, averaging 29% in migraine studies, can mask the true therapeutic effect of a drug**.<\/p>\n\n\n\n<p>In this phase III CNS migraine study, a biopharmaceutical company sought to evaluate the efficacy and safety of its drug for the acute treatment of migraines. The trial needed to demonstrate that the treatment was statistically differentiated from a placebo on two co-primary endpoints.<\/p>\n\n\n\n<p>It was therefore vital for the sponsor to minimize the placebo response rate to ensure the trial results were as accurate as possible. <\/p>\n\n\n\n<p>The eight month long trial took place in the US, involving 1,400 patients who suffered from acute migraines.<\/p>\n\n\n\n<p>* <a href=\"https:\/\/migraineresearchfoundation.org\/about-migraine\/migraine-facts\/\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/migraineresearchfoundation.org\/about-migraine\/migraine-facts\/<\/a><\/p>\n\n\n\n<p>** <a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00228-005-0088-5\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/link.springer.com\/article\/10.1007\/s00228-005-0088-5<\/a><\/p>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section light-grey-50\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"solution\">Solution<\/h2>\n\n\n\n<p>Clario\u2019s eCOA Clinical Science team created a tailored online training program specific to the requirements of the sponsor\u2019s migraine study. Patients were required to undertake the training, which was delivered via an interactive multimedia program with a comprehension quiz in both English and Spanish, and covered:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Patients\u2019 roles and responsibilities as study participants<\/li>\n\n\n\n<li>How to use the handheld devices to complete the electronic PatientReported Outcome Assessments (ePROs)<\/li>\n\n\n\n<li>What is meant by the placebo effect and how to answer questions about their symptoms accurately to minimize the placebo effect<\/li>\n<\/ul>\n\n\n\n<p>Clario&#8217;s eCOA handheld solution was then used to deliver both the Migraine Quality of Life (MQOL) and the Profile of Moods (POMs) questionnaires as well as alarm reminders.<\/p>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section\">\n  <div class=\"container\">\n      \n<div class=\"row\">\n\t\n\n<div class=\"col-12 col-md-9\">\n\t\t\t\n\n<h2 class=\"wp-block-heading\" id=\"impact\">Impact<\/h2>\n\n\n\n<p>Clario\u2019s patient training program cut the placebo response rate in half from that typically seen in migraine studies. This significant reduction delivered more accurate trial data and supported the successful outcome of the biopharma\u2019s PIII trial.<\/p>\n\n\n\n<p>\u201cEnsuring the patient is informed and educated about the study and their vital role can increase ePRO data quality and reduce data variance. Providing purpose built participant\u00a0training modules to better inform participants about the study and the ePRO assessments to be completed can lead to delivering higher-quality data in clinical trials, and can reduce placebo effect in certain indications\u201d comments Bryan McDowell, Vice President, eCOA Science, Clario.<\/p>\n\n\n\n<p>The trial also delivered high compliance rates. Investigative sites received email alerts when patients reported migraines, which allowed them to track when patients completed an assessment and follow-up when necessary.<\/p>\n\n\t<\/div>\n\n<\/div>\n\n  <\/div>\n<\/div>\n\n\n<div class=\"clario-section clario-cta clario-cta-layout-standard  purple show-bg-pixel \">\n  <div class=\"container\">\n    <div class=\"row align-items-md-center\">\n        <div class=\"clario-cta-content col-md-6 offset-md-1 col-10\"><p class=\"h2\">Improve clinical trial data quality with Clario eCOA.<\/p><\/div><div class=\"cta-buttons offset-md-1 col-md-4 col-10\"><div class=\"clario-cta-action\"><a href=\"https:\/\/clario.com\/contact\/\" class=\"button cta-1 \">Talk to a specialist<\/a><\/div><\/div>    <\/div>\n  <\/div>\n<\/div>\n","protected":false},"featured_media":0,"template":"","tags":[377],"solution_areas":[42],"therapeutic_area":[],"class_list":["post-1460","case_study","type-case_study","status-publish","hentry","tag-pharma"],"acf":[],"cp_meta_data":{"inline_featured_image":["0"],"_edit_lock":["1751407279:7"],"_edit_last":["7"],"page_title":[""],"_page_title":["field_615dbd9cfca50"],"case_study_introduction":["<h3>Clario\u2019s training program directly contributes to significantly lower placebo response rate in successful PIII migraine CNS study<\/h3>\r\n<h4><strong>Summary<\/strong><\/h4>\r\n<ul>\r\n \t<li>8 month PIII CNS migraine study<\/li>\r\n \t<li>Patient training included in eCOA solution<\/li>\r\n \t<li>Placebo response rate cut in half<\/li>\r\n<\/ul>\r\n<h4><strong>Impact<\/strong><\/h4>\r\n<ul>\r\n \t<li>Patient training significantly reduced placebo response rate<\/li>\r\n \t<li>Data showed drug statistically differentiated from placebo<\/li>\r\n \t<li>Training contributed to successful trial<\/li>\r\n<\/ul>"],"_case_study_introduction":["field_6152dce77ed78"],"case_study_image":[""],"_case_study_image":["field_6152dce77edb8"],"case_study_download":["11970"],"_case_study_download":["field_6152dd05722c5"],"external_link":[""],"_external_link":["field_615ef0c11046c"],"_yoast_wpseo_focuskeywords":["[{\"keyword\":\"Migraine\",\"score\":87},{\"keyword\":\"eCOA\",\"score\":60},{\"keyword\":\"placebo\",\"score\":87},{\"keyword\":\"migraine studies\",\"score\":73}]"],"_yoast_wpseo_keywordsynonyms":["[\"\",\"\",\"\",\"\",\"\"]"],"_yoast_wpseo_estimated-reading-time-minutes":["2"],"_wp_old_date":["2021-10-20"],"asset_link":[""],"_asset_link":["field_61746513234de"],"_yoast_wpseo_content_score":["60"],"_yoast_indexnow_last_ping":["1751407277"],"persistent_cta":["hide"],"_persistent_cta":["field_6375dc7c0b25c"],"show_popup":["0"],"_show_popup":["field_62b1aec56dcb5"],"_yoast_wpseo_wordproof_timestamp":[""],"bt_post_experiments_editor":["gutenberg"],"_yoast_wpseo_focuskw":["Study participant training"],"_yoast_wpseo_metadesc":["Explore the efficacy and safety of a new drug for migraine treatment. Learn how a phase III study evaluated the effectiveness of the treatment compared to a placebo."],"_yoast_wpseo_linkdex":["49"],"_ame_cpe_post_policy":["{\"accessProtection\":{\"active\":\"replace\"}}"]},"_links":{"self":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study\/1460","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study"}],"about":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/types\/case_study"}],"version-history":[{"count":0,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/case_study\/1460\/revisions"}],"wp:attachment":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media?parent=1460"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/tags?post=1460"},{"taxonomy":"solution_areas","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/solution_areas?post=1460"},{"taxonomy":"therapeutic_area","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/therapeutic_area?post=1460"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}