{"id":11035,"date":"2024-03-26T12:01:16","date_gmt":"2024-03-26T12:01:16","guid":{"rendered":"https:\/\/www.healthnews.ie\/?p=11035"},"modified":"2024-03-28T09:03:34","modified_gmt":"2024-03-28T09:03:34","slug":"streamlining-medtech-clinical-trial-development-with-end-to-end-support","status":"publish","type":"post","link":"https:\/\/www.healthnews.ie\/future-of-healthcare\/streamlining-medtech-clinical-trial-development-with-end-to-end-support\/","title":{"rendered":"Streamlining medtech clinical trial development with end-to-end support"},"content":{"rendered":"\n<div style=\"background-color:#f2f2f2;color:#32373c\" class=\"wp-block-atomic-blocks-ab-profile-box round ab-has-avatar ab-font-size-14 ab-block-profile ab-profile-columns\"><div class=\"ab-profile-column ab-profile-avatar-wrap\"><div class=\"ab-profile-image-wrap\"><figure class=\"ab-profile-image-square\"><img loading=\"lazy\" decoding=\"async\" width=\"250\" height=\"250\" class=\"ab-profile-avatar wp-image-11037\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/ProfFidelmaHiggins-9928-1.jpg\" alt=\"\" srcset=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/ProfFidelmaHiggins-9928-1.jpg 250w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/ProfFidelmaHiggins-9928-1-125x125.jpg 125w\" sizes=\"auto, (max-width: 250px) 100vw, 250px\" \/><\/figure><\/div><\/div><div class=\"ab-profile-column ab-profile-content-wrap\"><h2 class=\"ab-profile-name\" style=\"color:#32373c\">Professor Fidelma Dunne<\/h2><p class=\"ab-profile-title\" style=\"color:#32373c\">Director of the Institute for Clinical Trials, University of Galway<\/p><div class=\"ab-profile-text\"><\/div><ul class=\"ab-social-links\"><\/ul><\/div><\/div>\n\n\n\n<div style=\"background-color:#f2f2f2;color:#32373c\" class=\"wp-block-atomic-blocks-ab-profile-box round ab-has-avatar ab-font-size-14 ab-block-profile ab-profile-columns\"><div class=\"ab-profile-column ab-profile-avatar-wrap\"><div class=\"ab-profile-image-wrap\"><figure class=\"ab-profile-image-square\"><img loading=\"lazy\" decoding=\"async\" width=\"250\" height=\"250\" class=\"ab-profile-avatar wp-image-11036\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/Professor-Fidelma-Dunne-and-John-Kilmartin.jpg\" alt=\"\" srcset=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/Professor-Fidelma-Dunne-and-John-Kilmartin.jpg 250w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205907\/Professor-Fidelma-Dunne-and-John-Kilmartin-125x125.jpg 125w\" sizes=\"auto, (max-width: 250px) 100vw, 250px\" \/><\/figure><\/div><\/div><div class=\"ab-profile-column ab-profile-content-wrap\"><h2 class=\"ab-profile-name\" style=\"color:#32373c\">John Kilmartin<\/h2><p class=\"ab-profile-title\" style=\"color:#32373c\">Medtech Regulatory Consultant, Adjunct Professor at University of Galway<\/p><div class=\"ab-profile-text\"><\/div><ul class=\"ab-social-links\"><\/ul><\/div><\/div>\n\n\n\n<p><em>Ireland excels in medical innovation, hosting top medtech and pharma firms. However, innovators face hurdles hindering full potential realisation.<\/em><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>According to Professor Fidelma Dunne, smaller companies may not have the experience or know where to obtain the support and expertise to get a great idea to the clinical trial stage.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.universityofgalway.ie\/instituteforclinicaltrials\/\" target=\"_blank\" rel=\"noreferrer noopener\">The Institute of Clinical Trials<\/a> was established at the <a href=\"https:\/\/universityofgalway.ie\/\" target=\"_blank\" rel=\"noreferrer noopener\">University of Galway<\/a> to ensure that Irish innovation in the medtech and pharma sector remains a world leader.<\/p>\n\n\n<div id=\"healt-2342399544\"><div class=\"healt-adlabel\">Advertisements<\/div><div id=\"healt-3364332837\" style=\"margin-top: 30px;margin-bottom: 30px;margin-left: auto;margin-right: auto;text-align: center;\"><a data-no-instant=\"1\" href=\"https:\/\/www.universityofgalway.ie\/instituteforclinicaltrials\/\" rel=\"noopener\" class=\"a2t-link\" target=\"_blank\" aria-label=\"Galway2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2.jpg\" alt=\"\"  srcset=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2.jpg 1563w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2-768x256.jpg 768w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2-1536x512.jpg 1536w\" sizes=\"auto, (max-width: 1563px) 100vw, 1563px\" width=\"750\" height=\"250\"  style=\"display: inline-block;\" \/><\/a><\/div><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"h-comprehensive-clinical-trial-support\"><strong>Comprehensive clinical trial support<\/strong><\/h2>\n\n\n\n<p>Dunne, the Institute\u2019s director, says the Institute offers end-to-end support in conducting clinical trials in processes such as addressing regulatory hurdles, appropriate trial design and protocol development, supplementary development of supporting systematic reviews, core outcome sets and use of patient-reported outcomes, health economic analysis and communicating findings to ensure patient impacts.<\/p>\n\n\n\n<p>\u201cThe Institute is poised to take people along a continuum of clinical research from the very beginning when thinking about a trial and putting a trial design together, through to delivering the final report to stakeholders,\u201d she adds. \u201cWe also pledge to ensure that clinical trial results have a meaningful output to health services and patients.\u201d<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>Ireland has the highest per capita <br>employment of medtech professionals <br>in Europe, so we punch above our weight.<\/p>\n<cite>Mr John Kilmartin<\/cite><\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-five-pillars-of-clinical-trial-design\"><strong>Five pillars of clinical trial design<\/strong><\/h2>\n\n\n\n<p>Institute activities are designed around five pillars: developing partnerships with stakeholders, creating an Accelerator Hub with experts to make the delivery of the clinical trial process simpler; looking at trial designs and additional activities researchers may not have thought about; education and training; translating results into policy guidelines and impact to healthcare.<\/p>\n\n\n\n<p>\u201cHaving people to help with writing as well as navigating through the documentation will relieve pressure for those inexperienced in such areas but who nonetheless might have a great device or idea,\u201d adds Dunne.<\/p>\n\n\n\n<p>She says it is crucial to capture good ideas and avoid them being developed elsewhere, as failure to do so would mean: \u201cIrish patients, the Irish economy and the Irish health system are losing out.\u201d<\/p>\n\n\n<div id=\"healt-3004394579\"><div class=\"healt-adlabel\">Advertisements<\/div><div id=\"healt-1225394290\" style=\"margin-top: 30px;margin-bottom: 30px;margin-left: auto;margin-right: auto;text-align: center;\"><a data-no-instant=\"1\" href=\"https:\/\/www.universityofgalway.ie\/instituteforclinicaltrials\/\" rel=\"noopener\" class=\"a2t-link\" target=\"_blank\" aria-label=\"Galway2\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2.jpg\" alt=\"\"  srcset=\"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2.jpg 1563w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2-768x256.jpg 768w, https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205905\/Galway2-1536x512.jpg 1536w\" sizes=\"auto, (max-width: 1563px) 100vw, 1563px\" width=\"750\" height=\"250\"  style=\"display: inline-block;\" \/><\/a><\/div><\/div>\n\n\n<h2 class=\"wp-block-heading\" id=\"h-success-for-ireland-s-medtech-sector\"><strong>Success for Ireland\u2019s medtech sector<\/strong><\/h2>\n\n\n\n<p>Independent medtech regulatory expert Mr John Kilmartin, Adjunct Professor at the University, says Ireland\u2019s medtech sector is a fantastic success story with a mix of multinationals, SMEs and innovators.<\/p>\n\n\n\n<p>\u201cWith about 450 companies,\u201d he continues, \u201cIreland has the highest per capita employment of medtech professionals in Europe, so we punch above our weight. \u201cHowever, there is still an opportunity for more clinical research to be conducted. At the Institute, we have all the ingredients \u2014 clinicians, SMEs multinationals, academic infrastructure \u2014 and can provide a fantastic coordination role.\u201d<\/p>\n\n\n\n<p>Kilmartin says the Institute can also play a strategic role in dealing with regulators, ethics committees and sponsors, as well as in tactical execution and implementation of trials.<\/p>\n\n\n<!DOCTYPE html PUBLIC \"-\/\/W3C\/\/DTD HTML 4.0 Transitional\/\/EN\" \"http:\/\/www.w3.org\/TR\/REC-html40\/loose.dtd\">\n<html><body><div style=\"text-align:center\" class=\"wp-block-atomic-blocks-ab-button ab-block-button\"><a href=\"https:\/\/universityofgalway.ie\/\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"ab-button ab-button-shape-rounded ab-button-size-medium fb-pixel\" style=\"color:#ffffff;background-color:#a80050\">Click here to learn more<\/a><\/div>\n<\/body><\/html>\n","protected":false},"excerpt":{"rendered":"<p>Ireland excels in medical innovation, hosting top medtech and pharma firms. However, innovators face hurdles hindering full potential realisation. According to Professor Fidelma Dunne, smaller companies may not have the experience or know where to obtain the support and expertise to get a great idea to the clinical trial stage. The Institute of Clinical Trials &hellip; <a href=\"https:\/\/www.healthnews.ie\/future-of-healthcare\/streamlining-medtech-clinical-trial-development-with-end-to-end-support\/\">Continued<\/a><\/p>\n","protected":false},"author":23,"featured_media":11039,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5714],"tags":[5889],"class_list":["post-11035","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-future-of-healthcare","tag-future-of-healthcare-q1-2024"],"acf":[],"featured_image_src":"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205906\/GettyImages-1320799464-600x400.jpg","featured_image_src_square":"https:\/\/s3.eu-north-1.amazonaws.com\/cdn-site.mediaplanet.com\/app\/uploads\/sites\/94\/2024\/03\/07205906\/GettyImages-1320799464-600x600.jpg","author_info":{"display_name":"Your Future Career","author_link":"https:\/\/www.healthnews.ie\/author\/harveyodonnell\/"},"vicky_category_order":[{"category_id":5714,"order":"3"}],"vicky_index_order":"","_links":{"self":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/11035","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/users\/23"}],"replies":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/comments?post=11035"}],"version-history":[{"count":9,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/11035\/revisions"}],"predecessor-version":[{"id":11132,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/posts\/11035\/revisions\/11132"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/media\/11039"}],"wp:attachment":[{"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/media?parent=11035"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/categories?post=11035"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.healthnews.ie\/wp-json\/wp\/v2\/tags?post=11035"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}