{"id":9853,"date":"2021-09-07T09:17:09","date_gmt":"2021-09-07T09:17:09","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=9853"},"modified":"2021-09-15T14:00:01","modified_gmt":"2021-09-15T14:00:01","slug":"who-and-icmra-announce-a-joint-statement-on-data-transparency-and-integrity","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2021\/09\/07\/who-and-icmra-announce-a-joint-statement-on-data-transparency-and-integrity\/","title":{"rendered":"WHO and ICMRA announce a joint statement on data transparency and integrity"},"content":{"rendered":"<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"9860\" data-permalink=\"https:\/\/thepublicationplan.com\/2021\/09\/07\/who-and-icmra-announce-a-joint-statement-on-data-transparency-and-integrity\/lock-open-and-closed\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?fit=591%2C591&amp;ssl=1\" data-orig-size=\"591,591\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;Getty Images\/iStockphoto&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;Opened and closed lock icons isolated on blue background, yellow padlocks shapes flat illustration concept for web banners, web and mobile app, web sites, printed materials, infographics&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;drogatnev&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;Lock open and  closed&quot;,&quot;orientation&quot;:&quot;1&quot;}\" data-image-title=\"\" data-image-description=\"\" data-image-caption=\"\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?fit=300%2C300&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?fit=591%2C591&amp;ssl=1\" class=\"size-full wp-image-9860 aligncenter\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?resize=591%2C591&#038;ssl=1\" alt=\"\" width=\"591\" height=\"591\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?w=591&amp;ssl=1 591w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?resize=150%2C150&amp;ssl=1 150w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?resize=250%2C250&amp;ssl=1 250w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?resize=50%2C50&amp;ssl=1 50w\" sizes=\"auto, (max-width: 591px) 100vw, 591px\" \/>The COVID-19 pandemic has exacerbated the need for <a href=\"https:\/\/thepublicationplan.com\/2021\/05\/12\/open-science-is-accelerated-as-a-result-of-the-covid-19-pandemic\/\" target=\"_blank\" rel=\"noopener\">data sharing<\/a> to support researchers, health authorities, healthcare professionals, and the public in the development, regulation, deployment, and understanding of new therapeutics and vaccines. In response to this, the <a href=\"https:\/\/www.who.int\/\" target=\"_blank\" rel=\"noopener\">World Health Organization<\/a> (WHO) and the <a href=\"http:\/\/icmra.info\/drupal\/en\/home\" target=\"_blank\" rel=\"noopener\">International Coalition of Medicines Regulatory Authorities<\/a> (ICMRA) released a <a href=\"https:\/\/www.who.int\/news\/item\/07-05-2021-joint-statement-on-transparency-and-data-integrityinternational-coalition-of-medicines-regulatory-authorities-(icmra)-and-who\" target=\"_blank\" rel=\"noopener\">joint statement<\/a> on transparency and data integrity, in which they urge the pharmaceutical industry to provide greater access to clinical data for all new medicines and vaccines, regardless of approval status. The statement, released in May, recommends that both positive and negative clinically relevant data are published in full, with only personal and individual patient data redacted.<\/p>\n<p>The cited benefits of this approach include:<\/p>\n<ul>\n<li>increased public trust and confidence in regulatory decisions<\/li>\n<li>opportunity to peer review the data to ensure they are robust, exhaustive, and verifiable<\/li>\n<li>removing the bias resulting from lack of public access to negative trial data<\/li>\n<li>faster advancements in research through optimisation of resources<\/li>\n<li>allowing trial participants to access data that they contributed to.<\/li>\n<\/ul>\n<p>Implementing this initiative will require consideration of factors such as availability of resources and systems needed for data sharing, and the timing of data release. WHO and ICMRA acknowledge that stakeholders may have concerns over increasing levels of transparency, but state that these are far outweighed by the resulting benefits to public health.<\/p>\n<blockquote>\n<p style=\"text-align: center;\">WHO and ICMRA acknowledge that stakeholders may have concerns over increasing levels of transparency, but state that these are far outweighed by the resulting benefits to public health.<\/p>\n<\/blockquote>\n<p>The statement notes that while some initiatives to improve data transparency and access have been successful (such as the WHO <a href=\"https:\/\/www.who.int\/clinical-trials-registry-platform\" target=\"_blank\" rel=\"noopener\">International Clinical Trials Registry Platform<\/a> or the US National Institutes of Health <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03043313\" target=\"_blank\" rel=\"noopener\">ClinicalTrials.gov<\/a> database), <a href=\"https:\/\/www.who.int\/news\/item\/18-05-2017-joint-statement-on-registration\" target=\"_blank\" rel=\"noopener\">such efforts<\/a> have not always been followed through, often due to lack of resourcing or reliance on goodwill. We look forward to seeing how this call to action is answered by the pharmaceutical industry.<\/p>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<div id=\"totalpoll\" class=\"totalpoll-wrapper totalpoll-uid-2e21fe0b6d537996d47c3d4b16d0e3cc is-ltr is-screen-vote\" totalpoll=\"9857\" totalpoll-uid=\"2e21fe0b6d537996d47c3d4b16d0e3cc\" totalpoll-screen=\"vote\" totalpoll-ajax-url=\"https:\/\/thepublicationplan.com\/wp-admin\/admin-ajax.php?action=totalpoll&totalpoll%5BpollId%5D=9857&totalpoll%5Baction%5D=view&totalpoll%5Bscreen%5D=vote\"><script type=\"text\/totalpoll-config\" totalpoll-config=\"9857\">{\"ajaxEndpoint\":\"https:\\\/\\\/thepublicationplan.com\\\/wp-admin\\\/admin-ajax.php?action=totalpoll\",\"behaviours\":{\"ajax\":true,\"scrollUp\":true,\"async\":false},\"effects\":{\"transition\":\"fade\",\"duration\":\"500\"},\"i18n\":{\"Previous\":\"Previous\",\"Next\":\"Next\",\"of\":\"of\",\"Something went wrong! Please try again.\":\"Something went wrong! Please try again.\"}}<\/script><link rel=\"stylesheet\" id=\"totalpoll-poll-2e21fe0b6d537996d47c3d4b16d0e3cc-css\"  href=\"https:\/\/thepublicationplan.com\/wp-content\/cache\/totalpoll\/css\/2e21fe0b6d537996d47c3d4b16d0e3cc.css\" type=\"text\/css\" media=\"all\" \/><div id=\"totalpoll-poll-9857\" class=\"totalpoll-container\"><form action=\"\" enctype=\"multipart\/form-data\" class=\"totalpoll-form\" method=\"POST\" novalidate=\"novalidate\"><div style=\"visibility: hidden; position: absolute; width: 0px; height: 0px;\">\r\n    <svg id=\"totalpoll-check-icon\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n        <path d=\"M0,0H24V24H0Z\" fill=\"none\"\/>\r\n        <path d=\"M9,15.1999l-4.2-4.2L2.3999,13.4,9,20.0001,22.0001,7,19.6,4.5999Z\"\/>\r\n    <\/svg>\r\n<\/div>\r\n    <div class=\"totalpoll-questions\">\r\n\t\t<div class=\"totalpoll-question\"\r\n     totalpoll-min-selection=\"1\"\r\n     totalpoll-max-selection=\"1\" >\r\n    <div class=\"totalpoll-question-container\">\r\n        <div class=\"totalpoll-question-content\" >\r\n\t\t\t<p>What do you think \u2013 will this call to action incite a positive change in clinical trial data sharing?<\/p>\n        <\/div>\r\n\r\n        <div class=\"totalpoll-question-choices\">\r\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-f30f2a9c-a945-4090-831f-a37dd91e0a0e-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-f30f2a9c-a945-4090-831f-a37dd91e0a0e-selector\" name=\"totalpoll[choices][c00035bd-703f-4a9b-8cfa-705f8f558f5d][]\" value=\"f30f2a9c-a945-4090-831f-a37dd91e0a0e\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Yes<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-c391a4a9-01d3-448f-9746-c4b1ca4858b2-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-c391a4a9-01d3-448f-9746-c4b1ca4858b2-selector\" name=\"totalpoll[choices][c00035bd-703f-4a9b-8cfa-705f8f558f5d][]\" value=\"c391a4a9-01d3-448f-9746-c4b1ca4858b2\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >No<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"choice-44a327ac-60c0-4203-b3e1-11b38628b50d-selector\" tabindex=\"0\"\r\n       class=\"totalpoll-question-choices-item totalpoll-question-choices-item-type-text \" >\r\n    <div class=\"totalpoll-question-choices-item-container\">\r\n        \r\n\t\t        \r\n        <div class=\"totalpoll-question-choices-item-control\">\r\n            <div class=\"totalpoll-question-choices-item-selector totalpoll-question-choices-item-selector-single\">\r\n\t\t\t\t<input type=\"radio\" id=\"choice-44a327ac-60c0-4203-b3e1-11b38628b50d-selector\" name=\"totalpoll[choices][c00035bd-703f-4a9b-8cfa-705f8f558f5d][]\" value=\"44a327ac-60c0-4203-b3e1-11b38628b50d\">                <div class=\"totalpoll-question-choices-item-selector-box\">\r\n                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\">\r\n                        <use xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"#totalpoll-check-icon\"><\/use>\r\n                    <\/svg>\r\n                <\/div>\r\n            <\/div>\r\n            <div class=\"totalpoll-question-choices-item-label\">\r\n                <span >Not sure<\/span>\r\n            <\/div>\r\n        <\/div>\r\n    <\/div>\r\n<\/label>\r\n\t\t\t\t\t\t\t            \r\n\t\t\t            \r\n        <\/div>\r\n    <\/div>\r\n<\/div>\r\n    <\/div>\r\n<div class=\"totalpoll-form-hidden-fields\">\r\n\t<div class=\"totalpoll-form-page\"><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[screen]\" value=\"vote\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[pollId]\" value=\"9857\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><div class=\"totalpoll-form-field-hidden\"><div class=\"totalpoll-form-field totalpoll-form-field-type-hidden totalpoll-column-full\"><div class=\"totalpoll-form-field-wrapper\"><input type=\"hidden\" name=\"totalpoll[action]\" value=\"\" class=\"totalpoll-form-field-input\"><div class=\"totalpoll-form-field-errors\"><\/div><\/div><\/div><\/div><\/div><\/div>\r\n<div class=\"totalpoll-buttons\">\r\n\t<button type=\"submit\" name=\"totalpoll[action]\" value=\"results\" class=\"totalpoll-button totalpoll-buttons-results\">Results<\/button><button type=\"submit\" name=\"totalpoll[action]\" value=\"vote\" class=\"totalpoll-button totalpoll-button-primary totalpoll-buttons-vote\">Vote<\/button><\/div>\r\n<\/form><\/div><\/div>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"9798\" data-permalink=\"https:\/\/thepublicationplan.com\/2021\/08\/24\/new-consort-extension-for-trials-using-cohorts-and-routinely-collected-data-consort-routine\/byline_rachel-hubbard-3\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?fit=618%2C75&amp;ssl=1\" data-orig-size=\"618,75\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"\" data-image-description=\"\" data-image-caption=\"\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?fit=300%2C36&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?fit=618%2C75&amp;ssl=1\" class=\"alignnone size-full wp-image-9798\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?resize=618%2C75&#038;ssl=1\" alt=\"\" width=\"618\" height=\"75\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?w=618&amp;ssl=1 618w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/Byline_Rachel-Hubbard.png?resize=300%2C36&amp;ssl=1 300w\" sizes=\"auto, (max-width: 618px) 100vw, 618px\" \/><\/p>\n<hr \/>\n","protected":false},"excerpt":{"rendered":"<p>Read about their call to action for the pharmaceutical industry to increase sharing of clinical trial data.<\/p>\n","protected":false},"author":1,"featured_media":9860,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"Read about their call to action for the pharmaceutical industry to increase sharing of clinical trial data. ","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"WHO and #ICMRA announce a joint statement on data transparency and integrity @WHO #PubPlan #medcomms #ISMPP ","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_publicize_connection_overrides":[],"_wpas_customize_per_network":false},"categories":[343162575,16950752],"tags":[343162488,343162400,343162419],"class_list":["post-9853","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-research-integrity","category-data-transparency","tag-best-practice","tag-data-sharing","tag-pharmaceutical-industry","post-has-thumbnail"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2021\/08\/iStock-629528318.jpg?fit=591%2C591&ssl=1","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5Yk5l-2yV","jetpack_likes_enabled":true,"jetpack-related-posts":[],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/9853","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/comments?post=9853"}],"version-history":[{"count":14,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/9853\/revisions"}],"predecessor-version":[{"id":9980,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/posts\/9853\/revisions\/9980"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/media\/9860"}],"wp:attachment":[{"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/media?parent=9853"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/categories?post=9853"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thepublicationplan.com\/wp-json\/wp\/v2\/tags?post=9853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}