{"id":448,"date":"2019-11-12T17:20:51","date_gmt":"2019-11-12T17:20:51","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=448"},"modified":"2021-01-08T20:31:55","modified_gmt":"2021-01-08T20:31:55","slug":"ich-gcp-renovation-the-way-forward","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=448","title":{"rendered":"ICH GCP Renovation. The way forward"},"content":{"rendered":"\n<h6><span style=\"color: #333333;\"><em>ICH E8 and E6 need modernizing to prepare for the future, a future that will bring future medicines, future trial designs and future data sources<\/em> [1].&nbsp; This is the so called ICH GCP Renovation project.<\/span><\/h6>\n<h6><span style=\"color: #333333;\"><em>On the 12th of January 2017, following the adoption of the integrated addendum update to GCP, The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced their plans for a more extensive revision of ICH-GCP in a reflection paper known as the \u201cGCP Renovation\u201d<\/em> [2].<\/span><\/h6>\n<h6><em><span style=\"color: #333333;\">The main goals are to provide updated guidance which is flexible enough to address the increasing diversity of clinical trials designs and data sources employed to support regulatory decisions.&nbsp; Also a guidance that is focused on the issues that are more critical for trial quality and that allows the involvement of external stakeholders.<\/span><\/em><\/h6>\n<h6><span style=\"color: #333333;\"><em>The underlying principles of human subject protection and data quality will remain<\/em> [2].<\/span><\/h6>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h3><span style=\"color: #7ecca5;\"><strong>Revision Process<\/strong><\/span><\/h3>\n<h4><span style=\"color: #808080;\"><strong>First Step: Renovation of ICH E8 General Considerations for Clinical Trials<\/strong><\/span><\/h4>\n<h6><span style=\"color: #333333;\">ICH E8 was finalized in 1997 and has not been updated subsequently. ICH E8 (R1) draft was released for public consultation in May 2019 [3].<\/span><\/h6>\n<h6><span style=\"color: #333333;\">The revision proposal focuses on data quality, including the concept of <span style=\"color: #808080;\"><strong>quality by design (QbD)<\/strong><\/span> as a key consideration in the study planning phases, which implies designing quality into the study protocol, procedures and associated operational plans.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Quality of a clinical study is considered in this draft document as <span style=\"color: #808080;\">\u201c<strong>fitness for purpose<\/strong>\u201d<\/span>.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">ICH E8 (R1) will include the need to identify a specific set of factors critical to the quality of a given study <span style=\"color: #808080;\">(<strong>critical to quality \u201cCtQ\u201d factors<\/strong>)<\/span>, and the strategies and actions (management of risks) that could effectively support quality in these critical areas to generate reliable data and ensure patients safety [2].<\/span><\/h6>\n<h6><span style=\"color: #333333;\">The <span style=\"color: #808080;\"><strong>periodic review<\/strong><\/span> of CtQ factors will also be a must since unanticipated issues may appear after the study begins. The review output will determine whether the current risk controls need to be adjusted.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Examples of CtQ factors include [4][5]:<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\">Protocol Design<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\">Eligibility criteria<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Randomization<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Masking<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Endpoints<\/span><\/h6>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Feasibility and study procedures<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Patient Safety<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\">Informed Consent<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Withdrawal criteria<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Data monitoring Committee\/ Stopping rules<\/span><\/h6>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Study Conduct<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\">Investigator\/site qualification<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Data recording and reporting<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Statistical analysis<\/span><\/h6>\n<\/li>\n<\/ul>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\">Study Reporting<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\">Communication of results<\/span><\/h6>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h6><span style=\"color: #333333;\">Other important aspect that will be covered is the engagement of multiple stakeholders in the study design, including patients and treating physicians.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">ICH E8 (R1) will also update the cross-referencing to the ICH guidance documents to facilitate study planning [1]. ICH E8 needs to be considered as the cornerstone, the foundation to talk about clinical trials. The ICH E family of guidelines need to be read together (Figur<\/span>e 1).<\/h6>\n<h6><img loading=\"lazy\" class=\"aligncenter wp-image-474\" src=\"https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=921%2C444&#038;ssl=1\" alt=\"GCP Renovation\" width=\"921\" height=\"444\" srcset=\"https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?w=908&amp;ssl=1 908w, https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=300%2C145&amp;ssl=1 300w, https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=768%2C370&amp;ssl=1 768w, https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=260%2C125&amp;ssl=1 260w, https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=50%2C24&amp;ssl=1 50w, https:\/\/i2.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/Figure-1-E8.png?resize=150%2C72&amp;ssl=1 150w\" sizes=\"(max-width: 921px) 100vw, 921px\" data-recalc-dims=\"1\" \/><span style=\"color: #333333;\">Quality should rely on good design rather than on retrospective document checking. Even if monitoring, audits and inspections are key processes, they are not enough to ensure the quality of a clinical trial. The deficiencies identified during these activities imply retrospective corrective and preventative actions, which sometimes include protocol amendments.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">It is important to avoid protocol amendments [1], as more complex trials have on average three protocol amendments.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">In summary, the key design principles will remain the same: the goal is to obtain high-quality evidence to inform decision-making [4].<\/span><\/h6>\n<h4><span style=\"color: #808080;\"><strong>Second Step: Renovation of ICH E6 Guideline for Good Clinical Practice<\/strong><\/span><\/h4>\n<h6><span style=\"color: #333333;\">ICH E6 R2 addendum was finalized in 2016. Since it was an addendum, the existing text could not be changed. It is considered as a quick fix that needs to be reoriented.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">ICH proposes a subsequent renovation of the current ICH E6 guideline. It will not be an addendum but a full rewrite.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">The renovation will preserve a key role for the current focus on traditional interventional trials conducted in a clinical trial setting, while also addressing a broader range of study types and data sources [4].<\/span><\/h6>\n<h6><span style=\"color: #333333;\">A relevant addition to the current ICH E6 (R2), will be a set of annexes that will address in more detail the particular study types and\/ or data sources:<\/span><\/h6>\n<ul>\n<li>\n<h6><span style=\"color: #333333;\"><span style=\"color: #808080;\"><strong>Annex 1:<\/strong><\/span> Traditional interventional trials of unapproved or approved drugs.<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\"><span style=\"color: #808080;\"><strong>Annex 2:<\/strong><\/span> Non-Traditional Interventional Trials or data sources (pragmatic, decentralized clinical trials).<\/span><\/h6>\n<\/li>\n<li>\n<h6><span style=\"color: #333333;\"><span style=\"color: #808080;\"><strong>Annex 3:<\/strong><\/span> Non-Traditional Trial Designs (observational studies, patients registries).<\/span><\/h6>\n<\/li>\n<\/ul>\n<h6><span style=\"color: #333333;\">It also plans to provide a more detailed workup of the CtQ factors that should be considered.<\/span><\/h6>\n<h6>T<span style=\"color: #333333;\">his new approach will provide flexibility to ensure the principles remain the same regardless of the study\u2019s objectives or setting.<\/span><\/h6>\n\n\n\n<h3><span style=\"color: #7ecca5;\"><strong>Timelines and next steps<\/strong><\/span><\/h3>\n<h4><span style=\"color: #808080;\"><strong>ICH E8 (R1)<\/strong><\/span><\/h4>\n<h6>T<span style=\"color: #333333;\">he last public stakeholder workshop focused on ICH E8 (R1) was held on the 31<sup>st<\/sup> of October 2019 in Washington DC (USA) [4].<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Two Experts Working Group (EWG) face to face meetings are expected in March and May 2020.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Finalization of the guidance document is expected in June 2020 [4].<\/span><\/h6>\n<h4><span style=\"color: #808080;\"><strong>ICH E6 (R3)<\/strong><\/span><\/h4>\n<h6><span style=\"color: #333333;\">The first face to face meeting to produce the ICH concept paper is planned for the 15-18th of November 2019 in Singapore. Work on the overarching principles and Annex 1 will continue.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">The overall estimated timeline for the adoption (step 4) of E6 is mid-2021. The adoption of E6 Annex 1 is estimated by the end of 2022, early 2023 [1].<\/span><\/h6>\n\n\n\n<h3><span style=\"color: #7ecca5;\"><strong>Conclusion<\/strong><\/span><\/h3>\n<h6><span style=\"color: #333333;\">The key message of the GCP Renovation project is that this venture is about changing the way we do things.<img loading=\"lazy\" class=\"size-medium wp-image-450 alignleft\" src=\"https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=300%2C225&#038;ssl=1\" alt=\"GCP Renovation\" width=\"300\" height=\"225\" srcset=\"https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=300%2C225&amp;ssl=1 300w, https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=768%2C576&amp;ssl=1 768w, https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?w=1024&amp;ssl=1 1024w, https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=195%2C146&amp;ssl=1 195w, https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=50%2C38&amp;ssl=1 50w, https:\/\/i1.wp.com\/www.pharmity.com\/staging\/wp-content\/uploads\/2019\/11\/72.png?resize=100%2C75&amp;ssl=1 100w\" sizes=\"(max-width: 300px) 100vw, 300px\" data-recalc-dims=\"1\" \/><\/span><\/h6>\n<h6><span style=\"color: #333333;\">We need to readjust the way we approach clinical trials since the clinical research arena is evolving and the current guidance will not be appropriate any longer, as data sources and other factors are expanding.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Fit-for-purpose clinical trials need to be promoted by achieving quality by good design. But how can we do that? <\/span><\/h6>\n<h6><span style=\"color: #333333;\">By introducing the quality by design concept and identifying critical to quality factors. In simple words, think first about the design, those aspects that are critical for the specific study and then do the work.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">The quality of the information and the reliability of the data generated should be enough to support good decision making.<\/span><\/h6>\n<h6><span style=\"color: #333333;\">Consider all parties, including patients and treatment physicians, when setting the foundations for the study design.<\/span><\/h6>\n\n\n\n<hr class=\"wp-block-separator\"\/>\n\n\n\n<h3><span style=\"color: #7ecca5;\"><strong>References<\/strong><\/span><\/h3>\n<ol>\n<li><span style=\"background-color: #ffffff;\">Sweeney. GCP Renovation &#8211; ICH E8 and ICH E6. 3<sup>rd<\/sup> European QA Conference, Dublin. November 2019<\/span><\/li>\n<li><span style=\"background-color: #ffffff;\">ICH Reflection on \u201cGCP Renovation\u201d: Modernization of ICH E8 and Subsequent Renovation of ICH E6. January 2017<\/span><\/li>\n<li><span style=\"background-color: #ffffff;\">ICH E8 (R1) General Considerations for Clinical Trials. Draft version. May2019<\/span><\/li>\n<li><span style=\"background-color: #ffffff;\">ICH Public Meeting E8 (R1) General Considerations for Clinical Studies. October 2019<\/span><\/li>\n<li><span style=\"background-color: #ffffff;\">CTTI-Clinical Trials Transformation Initiative. Exploring the critical to quality (CTQ) factors (<a style=\"background-color: #ffffff;\" href=\"https:\/\/www.ctti-clinicaltrials.org\/toolkit\/qbd\/introduce-qbd\/qbd-principles\/explore-ctq-factors\">https:\/\/www.ctti-clinicaltrials.org\/toolkit\/qbd\/introduce-qbd\/qbd-principles\/explore-ctq-factors<\/a>)<\/span><\/li>\n<\/ol>\n\n\n\n<h6>&nbsp;<\/h6>\n<h6><strong><span style=\"color: #7ecca5;\">Author: Dr Leire Z\u00fa\u00f1iga, Director and Principal GCP <\/span><\/strong><strong><span style=\"color: #7ecca5;\">Consultant<\/span><\/strong><\/h6>\n<h6><strong><span style=\"color: #7ecca5;\">PHARMITY, 12<sup>th<\/sup> November 2019<\/span><\/strong><\/h6>\n<h6><a href=\"http:\/\/www.pharmity.com\/staging\">www.pharmity.com<\/a><\/h6>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ICH E8 and E6 need modernizing to prepare for the future, a future that will bring future medicines, future trial designs and future data sources [1].&nbsp; This is the so called ICH GCP Renovation project. On the 12th of January 2017, following the adoption of the integrated addendum update to<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":3,"featured_media":869,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"spay_email":""},"categories":[17],"tags":[18],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.0.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ICH GCP Renovation. The way forward - Pharmity<\/title>\n<meta name=\"description\" content=\"ICH GCP Renovation. The way forward | This article will explain the ICH revision proposal for ICH GCP that reinforces Quality by Design and the critical to quality factors\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ICH GCP Renovation. 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