{"id":156,"date":"2015-04-08T18:43:10","date_gmt":"2015-04-08T18:43:10","guid":{"rendered":"http:\/\/depts.washington.edu\/cfrtc\/?page_id=156"},"modified":"2024-10-27T17:48:23","modified_gmt":"2024-10-28T00:48:23","slug":"clinical","status":"publish","type":"page","link":"https:\/\/depts.washington.edu\/cfrtc\/clinical\/","title":{"rendered":"Clinical and Biostatistical Core"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_fullwidth_slider admin_label=&#8221;Fullwidth Slider&#8221; module_id=&#8221;interior&#8221; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; custom_padding_tablet=&#8221;|||&#8221; custom_padding_phone=&#8221;|||&#8221; box_shadow_style=&#8221;preset6&#8243; box_shadow_blur=&#8221;10px&#8221; box_shadow_color=&#8221;rgba(0,0,0,0.1)&#8221; show_inner_shadow=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off&#8221; 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button_one_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_letter_spacing__hover_enabled=&#8221;off&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221; sticky_transition=&#8221;on&#8221;][\/et_pb_slide][\/et_pb_fullwidth_slider][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_4,3_4&#8243; _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_sidebar area=&#8221;et_pb_widget_area_5&#8243; admin_label=&#8221;Clinical Core Sidebar&#8221; _builder_version=&#8221;4.16&#8243; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_sidebar][\/et_pb_column][et_pb_column type=&#8221;3_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;Clinical and Biostatistical Core&#8221; _builder_version=&#8221;4.23.2&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1>Clinical and Biostatistical Core Services<\/h1>\n<p>The specific objectives of the Clinical Core are as follows:<\/p>\n<h4>Provide preclinical support for novel therapeutics<\/h4>\n<p>The specific aims of the preclinical support services are:<\/p>\n<ul>\n<li>Develop mechanisms for preclinical review and consulting in order to promote the development and\/or commercialization of promising translational research programs.<\/li>\n<li>Provide detailed assistance with the development of regulatory strategies and submissions to the Food and Drug Administration (FDA) for clinical development.<\/li>\n<\/ul>\n<h4>Develop clinical protocols, and provide consultation and personnel for implementation of early clinical trials<\/h4>\n<p>The specific aims of the clinical protocol and implementation support services are:<\/p>\n<ul>\n<li>Provide detailed assistance with the development of the clinical research plans of promising therapeutics for phase 1 and proof of concept phase 2 human clinical trials that would meet all FDA requirements.<\/li>\n<li>Provide detailed assistance with the implementation of these research plans and support investigators in moving promising therapeutics into phase 1 and proof of concept phase 2 human clinical trials that would support an FDA approved clinical development plan and eventual approval for patients with cystic fibrosis.<\/li>\n<\/ul>\n<h4>Enhance and support bacterial and human specimen repositories<\/h4>\n<p>The specific aims of the biorepository support services are to:<\/p>\n<ul>\n<li>Create a biospecimen discovery portal for identification of CF samples (human and bacterial) that are available for research within the Seattle consortium.<\/li>\n<li>Create a specimen requisition process that will permit investigators to request specific specimen types from the repository or for prospective acquisition.<\/li>\n<\/ul>\n<h4>Developmental Research and Training<\/h4>\n<p>The specific aims of the developmental research and training support services are to:<\/p>\n<ul>\n<li>Develop novel outcome measures for translational research and efficient biostatistical approaches to inform translational study designs.<\/li>\n<li>Develop a robust clinical research training program for CF translational investigators including dissemination of &#8220;tool kits&#8221; for study development and implementation.<\/li>\n<\/ul>\n<p><strong>Supported by a grant from the National Institutes of Health (<a href=\"http:\/\/www.niddk.nih.gov\/Pages\/default.aspx\" target=\"_blank\" rel=\"noopener\">NIDDK<\/a> P30 DK 89507) and the Cystic Fibrosis Foundation (SINGH19R0 and SINGH24R0). Please reference these grant numbers on all publications resulting from support provided by this Core Center grant.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical and Biostatistical Core Services The specific objectives of the Clinical Core are as follows: Provide preclinical support for novel therapeutics The specific aims of the preclinical support services are: Develop mechanisms for preclinical review and consulting in order to promote the development and\/or commercialization of promising translational research programs. Provide detailed assistance with the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":"","_links_to":"","_links_to_target":""},"_links":{"self":[{"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/pages\/156"}],"collection":[{"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/comments?post=156"}],"version-history":[{"count":34,"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/pages\/156\/revisions"}],"predecessor-version":[{"id":2953,"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/pages\/156\/revisions\/2953"}],"wp:attachment":[{"href":"https:\/\/depts.washington.edu\/cfrtc\/wp-json\/wp\/v2\/media?parent=156"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}