{"id":4171,"date":"2022-01-12T10:37:28","date_gmt":"2022-01-12T10:37:28","guid":{"rendered":"https:\/\/perseivivarium.com\/blog\/?p=4171"},"modified":"2024-02-09T09:14:03","modified_gmt":"2024-02-09T09:14:03","slug":"what-are-ecoas-in-a-clinical-study","status":"publish","type":"post","link":"https:\/\/perseivivarium.com\/blog\/what-are-ecoas-in-a-clinical-study\/","title":{"rendered":"What are eCOAs in a clinical study?"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221;][et_pb_row _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221;][et_pb_text _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;-70px||||false|false&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h1>What are eCOAs in a clinical study?<\/h1>\n<p>by Ana D\u00edaz-Roncero, January 12, 2022<\/p>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2022\/01\/What-are-eCOAs-in-a-clinical-study.jpg&#8221; title_text=&#8221;What are eCOAs in a clinical study&#8221; _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221; width=&#8221;85%&#8221; module_alignment=&#8221;center&#8221;][\/et_pb_image][et_pb_text _builder_version=&#8221;4.8.1&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p><b>The COVID-19 crisis demonstrated the need to accelerate the management of documentation in clinical studies<\/b><span style=\"font-weight: 400;\">, and to encourage the implementation of remote documentation.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This distance management of clinical studies is not only limited to the documentation but, thanks to technology, expands beyond that. In fact, in our article<\/span><a href=\"https:\/\/perseivivarium.com\/blog\/what-is-a-decentralized-clinical-trial-and-what-advantages-does-it-offer\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u00a0&#8220;What is a Decentralized Clinical Trial and what advantages does it offer?&#8221;<\/a> <span style=\"font-weight: 400;\">we have already talked about the consolidation of <strong>decentralized clinical studies.<\/strong><\/span><strong>\u00a0<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">This has resulted in a new way of collecting the <\/span><b>Clinical Outcome Assessments (COA)<\/b><span style=\"font-weight: 400;\">. The<\/span><a href=\"https:\/\/www.fda.gov\/about-fda\/clinical-outcome-assessment-coa-frequently-asked-questions#COADefinition\" target=\"_blank\" rel=\"noopener noreferrer\"> FDA<\/a> <span style=\"font-weight: 400;\">defines the COA as <\/span><b>\u201ca measure that describes or reflects how a patient feels, functions, or survives\u201d.<\/b><span style=\"font-weight: 400;\">\u00a0It involves data collected in the context of a clinical study that <\/span><b>can<\/b> <b>be reported by doctors, observers, or patients<\/b><span style=\"font-weight: 400;\">. For that reason, we can divide the COAs into four groups:<\/span><\/p>\n<ul>\n<li><b>Clinician-reported outcome (ClinRO)\u00a0measures<\/b><\/li>\n<li><strong>Observer-reported outcome (ObsRO)\u00a0measures<\/strong><\/li>\n<li><strong>Patient-reported outcome (PRO)\u00a0measures<\/strong>, which<a href=\"https:\/\/perseivivarium.com\/blog\/patient-reported-outcomes-pro-and-patient-reported-outcomes-measures-prom-what-are-they-and-what-do-they-provide\/\" target=\"_blank\" rel=\"noopener noreferrer\"> we have already discussed<\/a> in our blog, an<\/li>\n<li><strong>Performance outcome (PerfO)\u00a0measures <\/strong><\/li>\n<\/ul>\n<p>When these data are gathered in a digital form, they are called an<b> eCOA (Electronic Clinical Outcome Assessment).<\/b><\/p>\n<p><b>The use of the eCOA in the management of clinical studies offers obvious advantages<\/b><span style=\"font-weight: 400;\">, which could include:\u00a0<\/span><b>eliminating costs<\/b><span style=\"font-weight: 400;\"> related to paper registries; <\/span><b>structuring the data<\/b><span style=\"font-weight: 400;\"> to facilitate the extraction of results; <\/span><b>optimizing resources<\/b><span style=\"font-weight: 400;\">; offering patients and physicians<\/span><b> flexibility<\/b><span style=\"font-weight: 400;\"> when providing the information;<\/span><b> increasing the inclination of the patients<\/b><span style=\"font-weight: 400;\"> to participate; <\/span><b>providing information in real-time<\/b><span style=\"font-weight: 400;\"> about the results of the study; obtaining data<\/span><b> reported by the patients<\/b><span style=\"font-weight: 400;\"> themselves, etc.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ultimately, the use of eCOAs is another step in the implementation of clinical studies; it enables not only <\/span><b>improvement of the management process<\/b><span style=\"font-weight: 400;\">, but also the <\/span><b>collection of results<\/b><span style=\"font-weight: 400;\">, providing more complete data about the disease and enabling the progression toward more patient-centered medicine.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For all these reasons, at<\/span><a href=\"https:\/\/perseivivarium.com\/\" target=\"_blank\" rel=\"noopener noreferrer\"> <span style=\"font-weight: 400;\">Persei vivarium<\/span><\/a> <span style=\"font-weight: 400;\">we facilitate this work by providing our technology for the implementation and management of clinical studies in a way that is <\/span><b>secure, structured, and centralized<\/b><span style=\"font-weight: 400;\">, thus<\/span><b> enabling the collection of data by not only researchers and healthcare professionals, but also by the patients.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">The management of clinical studies is progressing, thanks to technology, and will continue to do so, enabling the collection of data provided by the patients themselves and the efficient reporting of clinical results. This will assure continuous improvement of the management of diseases and, therefore, will also continue impacting the patients\u2019 quality of life.<\/span><\/p>\n<p><a href=\"https:\/\/twitter.com\/hashtag\/eCOA?src=hashtag_click\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">#eCOA\u00a0<\/span><\/a><a href=\"https:\/\/twitter.com\/hashtag\/ClinicalOutcomeAssessment?src=hashtag_click\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">#ClinicalOutcomeAssessment\u00a0<\/span><\/a><a href=\"https:\/\/twitter.com\/hashtag\/DigitalHealth?src=hashtag_click\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">#DigitalHealth<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\"><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;20px|0px|0px|0px&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;3.27.4&#8243;]<\/p>\n<h4>Share<\/h4>\n<p>[\/et_pb_text][et_pb_code _builder_version=&#8221;3.19.8&#8243; link_option_url_new_window=&#8221;on&#8221;][\/et_pb_code][et_pb_team_member name=&#8221;Ana D\u00edaz-Roncero&#8221; position=&#8221;Business Development&#8221; image_url=&#8221;https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2021\/05\/Ana-Diaz-Roncero.jpg&#8221; _builder_version=&#8221;4.8.1&#8243; link_option_url=&#8221;https:\/\/www.linkedin.com\/in\/ana-diaz-roncero-gonzalez\/&#8221; link_option_url_new_window=&#8221;on&#8221; hover_enabled=&#8221;0&#8243; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>Persei vivarium<\/p>\n<p>[\/et_pb_team_member][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The COVID-19 crisis demonstrated the need to accelerate the management of documentation in clinical studies, and to encourage the implementation of remote documentation.<br \/>\nThis distance management of clinical studies is not only limited to the documentation but, thanks to technology, expands beyond that.<\/p>\n","protected":false},"author":2,"featured_media":4181,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"<!-- wp:divi\/placeholder \/-->","_et_gb_content_width":"","footnotes":""},"categories":[159],"tags":[188,249,11,248],"class_list":["post-4171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights","tag-clinical-studies","tag-clinical-trials","tag-digital-health","tag-ecoa"],"_links":{"self":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4171","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/comments?post=4171"}],"version-history":[{"count":12,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4171\/revisions"}],"predecessor-version":[{"id":4188,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/4171\/revisions\/4188"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media\/4181"}],"wp:attachment":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media?parent=4171"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/categories?post=4171"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/tags?post=4171"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}