{"id":6002,"date":"2022-08-12T14:41:11","date_gmt":"2022-08-12T18:41:11","guid":{"rendered":"https:\/\/clariowebstg.wpengine.com\/?post_type=resource&#038;p=6002"},"modified":"2024-09-09T08:12:40","modified_gmt":"2024-09-09T12:12:40","slug":"regulatory-guidance-for-pro-strategy-in-oncology-trials","status":"publish","type":"downloads","link":"https:\/\/clario.com\/resources\/downloads\/regulatory-guidance-for-pro-strategy-in-oncology-trials\/","title":{"rendered":"Regulatory guidance for PRO\u00a0strategy in oncology trials"},"content":{"rendered":"\n<p>Oncology drug approvals are now based on more than just survival and tumor response. Regulators expect Sponsors to incorporate the patient voice and collect more symptomatic data to understand a drug\u2019s full impact on patients\u2019 functioning, wellbeing and quality of life. Failure to do so may lead to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Missing important patient symptoms and experiences<\/li>\n\n\n\n<li>Denial of getting patient-reported data on your drug label<\/li>\n<\/ul>\n\n\n\n<p>Ultimately it may make it harder to differentiate your drug in a highly competitive market.<\/p>\n\n\n\n<p>In our new guide, Kelly Dumais, Principal&nbsp;Scientific Advisor and Jowita Marszewska,&nbsp;Scientific Advisor at Clario eCOA, set out in more&nbsp;detail how these regulatory developments impact&nbsp;PRO Strategy.<\/p>\n","protected":false},"featured_media":2633,"template":"","tags":[131,66],"solution_areas":[42],"therapeutic_area":[39],"download_type":[325],"class_list":["post-6002","downloads","type-downloads","status-publish","has-post-thumbnail","hentry","tag-ecoa","tag-oncology","download_type-brochure"],"acf":[],"cp_meta_data":{"_edit_lock":["1725883962:24"],"_edit_last":["24"],"page_title":[""],"_page_title":["field_615dbd9cfca50"],"display_prefooter":["hide"],"_display_prefooter":["field_61641783f0f7c"],"resource_download":[""],"_resource_download":["field_623cdd9cc437d"],"external_link":[""],"_external_link":["field_615ef0c11046c"],"asset_link":[""],"_asset_link":["field_61746513234de"],"show_popup":["0"],"_show_popup":["field_62b1aec56dcb5"],"enable_gated_access":["1"],"_enable_gated_access":["field_61697763f967f"],"gated_header":["Fill out for brochure access"],"_gated_header":["field_61697700f967d"],"gated_form_embed":["<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/v2.js\"><\/script>\r\n<script>\r\n  hbspt.forms.create({\r\n    region: \"na1\",\r\n    portalId: \"7229613\",\r\n    formId: \"e1ca5c23-8151-47c9-af1f-eacdcb7382b2\"\r\n  });\r\n<\/script>"],"_gated_form_embed":["field_61697733f967e"],"_yoast_wpseo_content_score":["90"],"_yoast_wpseo_focuskeywords":["[]"],"_yoast_wpseo_keywordsynonyms":["[\"\"]"],"_yoast_wpseo_estimated-reading-time-minutes":["1"],"_yoast_wpseo_wordproof_timestamp":[""],"_thumbnail_id":["2633"],"_yoast_indexnow_last_ping":["1680776563"],"_yoast_post_redirect_info":["a:4:{s:6:\"origin\";s:64:\"resource\/regulatory-guidance-for-pro-strategy-in-oncology-trials\";s:6:\"target\";s:75:\"resources\/downloads\/regulatory-guidance-for-pro-strategy-in-oncology-trials\";s:4:\"type\";i:301;s:6:\"format\";s:5:\"plain\";}"],"persistent_cta":["hide"],"_persistent_cta":["field_6375dc7c0b25c"],"_yoast_wpseo_meta-robots-noindex":["2"],"bt_post_experiments_editor":["gutenberg"],"_yoast_wpseo_metadesc":["Kelly Dumais, Principal Scientific Advisor and Jowita Marszewska, Scientific Advisor at Clario eCOA, explores how regulatory developments impact PRO Strategy."]},"_links":{"self":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/downloads\/6002","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/downloads"}],"about":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/types\/downloads"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media\/2633"}],"wp:attachment":[{"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/media?parent=6002"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/tags?post=6002"},{"taxonomy":"solution_areas","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/solution_areas?post=6002"},{"taxonomy":"therapeutic_area","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/therapeutic_area?post=6002"},{"taxonomy":"download_type","embeddable":true,"href":"https:\/\/clario.com\/wp-json\/wp\/v2\/download_type?post=6002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}