{"id":207,"date":"2025-04-14T12:24:07","date_gmt":"2025-04-14T11:24:07","guid":{"rendered":"https:\/\/helsinn.com\/?page_id=207"},"modified":"2025-06-17T10:45:30","modified_gmt":"2025-06-17T09:45:30","slug":"clinical-data-sharing-governance","status":"publish","type":"page","link":"https:\/\/helsinn.com\/en_us\/esg\/ethics-and-governance\/clinical-data-sharing-governance\/","title":{"rendered":"Clinical Data Sharing Governance"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"207\" class=\"elementor elementor-207\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f7734d4 e-flex e-con-boxed e-con e-parent\" data-id=\"7f7734d4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4a95974 e-con-full e-flex e-con e-child\" data-id=\"4a95974\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46615dc2 top-title in-pages elementor-widget elementor-widget-heading\" data-id=\"46615dc2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ethics &amp; Governance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6750398 e-con-full e-flex e-con e-child\" data-id=\"6750398\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4dd1adb6 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"4dd1adb6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Clinical Data Sharing Governance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2a78d1c9 e-flex e-con-boxed e-con e-parent\" data-id=\"2a78d1c9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2c432f71 e-con-full img-dark-overlay e-flex e-con e-child\" data-id=\"2c432f71\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1a212b52 e-con-full e-flex e-con e-child\" data-id=\"1a212b52\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5f967c1e e-con-full elementor-hidden-mobile e-flex e-con e-child\" data-id=\"5f967c1e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-699a3cb e-flex e-con-boxed e-con e-parent\" data-id=\"699a3cb\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6f6f2752 e-con-full e-flex e-con e-child\" data-id=\"6f6f2752\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-48b0e5eb elementor-widget elementor-widget-text-editor\" data-id=\"48b0e5eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The responsible sharing of clinical trial data is part of Helsinn\u2019s commitment to supporting efficient clinical research that generates new learnings and brings benefits to patients.<\/p><p>Helsinn welcomes qualified researchers\u2019 requests for secondary research based on data from Helsinn-sponsored clinical trials whose primary results have been published in peer-reviewed journals, provided that the drug subject to the investigation has received, for the indication used in the trial, a marketing approval from regulatory authorities in the USA, the EU, and\/or Japan.<\/p><p>Access to clinical data may be provided in response to scientifically valid research proposals and is contingent upon both data request approval by a dedicated review committee and the execution of a data-sharing agreement with the researcher.<\/p><p>Data requestors are required to submit a research proposal to document their qualifications and the legitimacy of the research question. Research proposals should include the following:<\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">a description of the data being requested, including the hypothesis to be tested<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">a clear and robust study synopsis<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">a rationale for the proposed research<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">a well-documented and rigorous statistical analysis plan<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">qualifications and experience of the proposed research team<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">a description of any potential conflicts of interest, including potential competitive use of the data<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">the source of any research funding<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">an adequate publication and posting plan<\/li><\/ul><p>The sharing of data and other clinical trial information shall be consistent with the principle of safeguarding patient privacy and will not be accepted if there is a reasonable likelihood that individual patients could be identified or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws. Patients\u2019 informed consent relating to their participation in the clinical trial will always be respected. Any patient-level data that is shared will be anonymized to protect patients\u2019 personal data.<\/p><p>In some cases, clinical data may have been collected subject to legal, contractual or consent provisions that prohibit transfer to third parties. Such restrictions may preclude granting access to clinical trial data. Where legal restrictions prevent Helsinn from sharing certain kinds of data, Helsinn may work with qualified requestors to provide summary information where possible.<\/p><ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Data access will not be granted if the research proposal competes with Helsinn publication plan<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Qualified researchers who are provided access to Helsinn data must agree: to sign a data-sharing agreement with Helsinn; to publish the results of their analysis in a peer-reviewed journal or scientific meeting; not transfer the shared data or information to parties not identified in the research proposal, use the data for purposes not contained in the research proposal or seek to identify research participants<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7a2c510 e-flex e-con-boxed e-con e-parent\" data-id=\"7a2c510\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-53cb19f e-con-full e-flex e-con e-child\" data-id=\"53cb19f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b10fd13 elementor-widget elementor-widget-heading\" data-id=\"b10fd13\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Submit your clinical data sharing proposal<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10a659e e-con-full e-flex e-con e-child\" data-id=\"10a659e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2763bf0 elementor-widget elementor-widget-text-editor\" data-id=\"2763bf0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Please complete our online form to submit the clinical data sharing proposal.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb9f4d1 elementor-widget elementor-widget-button\" data-id=\"bb9f4d1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/helsinn.com\/en_us\/esg\/ethics-and-governance\/clinical-data-sharing-governance\/clinical-data-sharing-form\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">CLICK HERE FOR SUBMISSION<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d14d667 e-flex e-con-boxed e-con e-parent\" data-id=\"d14d667\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ce781a9 e-con-full e-flex e-con e-child\" data-id=\"ce781a9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-28b9426 elementor-widget elementor-widget-heading\" data-id=\"28b9426\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Privacy Statement<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12677be elementor-widget elementor-widget-text-editor\" data-id=\"12677be\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"pf0\">The provision of personal data by you may be necessary where in our legitimate interest in order for us to provide you with the requested services and for the performance of any contractual relationship with you. Because of our commitment to the protection of your personal data, we evaluate our privacy policies and procedures to implement improvements and refinements from time to time. Please read the\u00a0<a title=\"Privacy and Cookies Policy\" href=\"https:\/\/helsinn.com\/en_us\/terms-of-use\/privacy-and-cookies-policy\/\">Privacy and Cookies Policy<\/a>\u00a0carefully in order to understand our views and practices regarding your personal data and how we will treat it. The Privacy Policy is also a part of our\u00a0<a title=\"Terms of Use\" href=\"https:\/\/helsinn.com\/en_us\/terms-of-use\/terms-of-use\/\">Terms of Use<\/a>\u00a0for the Website.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Ethics &#038; Governance Clinical Data Sharing Governance The responsible sharing of clinical trial data is part of Helsinn\u2019s commitment to supporting efficient clinical research that generates new learnings and brings benefits to patients. Helsinn welcomes qualified researchers\u2019 requests for secondary research based on data from Helsinn-sponsored clinical trials whose primary results have been published in [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"parent":199,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-207","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/207","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/comments?post=207"}],"version-history":[{"count":7,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/207\/revisions"}],"predecessor-version":[{"id":1742,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/207\/revisions\/1742"}],"up":[{"embeddable":true,"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/pages\/199"}],"wp:attachment":[{"href":"https:\/\/helsinn.com\/en_us\/wp-json\/wp\/v2\/media?parent=207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}