{"id":2946,"date":"2019-02-05T11:55:01","date_gmt":"2019-02-05T09:55:01","guid":{"rendered":"https:\/\/alzheimer.noemi.lu\/?p=2946"},"modified":"2019-02-05T11:55:01","modified_gmt":"2019-02-05T09:55:01","slug":"epad-works-together-towards-the-poc-platform","status":"publish","type":"post","link":"https:\/\/ep-ad.org\/index.php\/2019\/02\/05\/epad-works-together-towards-the-poc-platform\/","title":{"rendered":"EPAD works together towards the PoC platform"},"content":{"rendered":"\n<p> 2019 started with great intensity! On 5 February, EPAD held its PoC (Proof of Concept) Kick Off meeting  in Berlin, Germany. The event brought together more than 100 delegates including site staff (principal investigators, sub-investigators, study coordinators, national leads), vendors and the wider EPAD PoC coordination team (the University of Edinburgh, Janssen, IQVIA) to showcase the PoC trial platform. For the first time, we gathered 30 sites (active and in set up) working on the project to share experiences, discuss PoC preparations and build core strategies.<\/p>\n\n\n\n<p>Prof Craig Ritchie, EPAD\nCo-coordinator (the University of Edinburgh), opened the meeting, thanking\nIQVIA for the organisation of the event and extending a special welcome to the site\nstaff and study team attending the event. He then introduced the EPAD project,\nits consortium, flow, structure and the PoC platform, which has been developed\nto run Phase II clinical trials with research participants with preclinical and\nprodromal Alzheimer\u2019s disease, with biomarker evidence of Alzheimer\u2019s disease\npathology using a consistent set of outcomes.<\/p>\n\n\n\n<p>We currently have 21 European sites enrolling and more than 1.450 research participants screened. Over the next months we will open additional sites.<a> <\/a>Trial Delivery Centres (TDCs) from 11 European countries are identified for participation in EPAD. There are a total of 35 TDCs currently selected for participation, with additional sites pending confirmation on participation. <\/p>\n\n\n\n<p>Prof Ritchie reported then that\nthe recruitment into the PoC is exclusively from the EPAD cohort of at-risk\nsubjects, the Longitudinal Cohort Study, known as the LCS.<\/p>\n\n\n\n<p><em>\u201cThe LCS has to be \u2018ready\u2019 to feed the right research participants into\nthe right research sites for the right trial\u201d, Prof Craig Ritchie.<\/em><\/p>\n\n\n\n<p>Following Prof Ritchie, Dr Kristy\nDraper, the EPAD Global Trial Lead (the University of Edinburgh), emphasised\nthe importance of the master protocol. She highlighted its design and the\nprogress towards the first PoC trial. The\nnegotiations with the first intervention owner are progressing well and we are\nhopeful that we will be able to begin start-up activities for the first PoC\nappendix in the spring. There was also an exciting announcement that the\ninclusion of the first participant in will likely happen in Q1 2020. In addition, the clinical candidate selection committee has\ntwo more interventions lined up with a scheduled start in 2020. <\/p>\n\n\n\n<p><em>\u201cWe are expecting 2019 to be a busy and\nexciting year as the EPAD team work with the first intervention owner to action\nall the plans made to begin the first trial within the EPAD PoC platform\u201d,\nKristy Draper.<\/em><\/p>\n\n\n\n<p>This meeting marked an important\nstage in the preparations for the PoC with almost all of the study sites coming\ntogether to plan and discuss readiness for the first appendix. Two workshop\nsessions were organised where each site had the opportunity to discuss and work\non the PoC readiness. Firstly, each site reflected on the barriers they might\nhave in term of recruitment as these will likely affect the capacity to also\nrun the PoC and identified ways to increase the number of trial-ready\nparticipants in the LCS. Secondly, they gave their thoughts on how to prepare\nthe participants for joining the PoC trial. These sessions were hugely valuable\nand the outputs from these have been collated. Our study sites were firmly at\nthe heart of the meeting. &nbsp;Prof Craig\nRitchie and Clare Dolan (the University of Edinburgh) took the floor for a scenario\nbetween a study staff member and a research participant. This particular\npractical discussion was displayed to draw together some of the issues the sites\ncould encounter as well as the participants\u2019 concerns during the initial\nconversation about the PoC. It was an amusing moment that reflected some of the\ncontent site staff may see in their own sites. <\/p>\n\n\n\n<p>After an energetic workshop\nsession discussing issues across sites and the generation of creative plans, John\nTracey from IQVIA presented an overview of 3<sup>rd<\/sup> Party Vendors. To\nclose the day, a few words were said by Craig Ritchie, <em>\u201cI hope to see you all in May for the EPAD General Assembly Meeting to\nbe held in Geneva\u201d<\/em>.<\/p>\n\n\n\n<p>With the PoC platform now kicked-off and attracting a great deal of interest from the pharmaceutical sector, it was encouraging to see how the sites are working together to support drug development. We are very pleased about the many conversations had and the enthusiasm for our innovative PoC platform. All our huge efforts are at a point of coming to fruition with compounds about to be tested in a streamlined and efficient way, delivering more effective, targeted interventions to prevent dementia.\u00a0 <\/p>\n","protected":false},"excerpt":{"rendered":"<p>2019 started with great intensity! On 5 February, EPAD held its PoC (Proof of Concept) Kick Off meeting in Berlin, Germany. The event brought together more than 100 delegates including site staff (principal investigators, sub-investigators, study coordinators, national leads), vendors and the wider EPAD PoC coordination team (the University of Edinburgh, Janssen, IQVIA) to showcase [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2947,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-2946","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts\/2946","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/comments?post=2946"}],"version-history":[{"count":0,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/posts\/2946\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/media\/2947"}],"wp:attachment":[{"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/media?parent=2946"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/categories?post=2946"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ep-ad.org\/index.php\/wp-json\/wp\/v2\/tags?post=2946"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}