{"id":3162,"date":"2024-06-10T11:22:29","date_gmt":"2024-06-10T15:22:29","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/decision-making-in-early-clinical-development\/"},"modified":"2024-08-21T12:03:58","modified_gmt":"2024-08-21T16:03:58","slug":"decision-making-in-early-clinical-development","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/decision-making-in-early-clinical-development\/","title":{"rendered":"Decision Making in Early Clinical Development"},"content":{"rendered":"<p>On March 16th and 17th the 5th East User Group Meeting took place in London. \u00a0This very successful 2 days saw a variety of talks on aspects of clinical trial design innovation. \u00a0Over the next couple of weeks, we will be reviewing\u00a0some of the key topics which were addressed during the meeting.<\/p>\n<p>In this post, we&#8217;ll take a look at\u00a0Paul Frewer of Astrazeneca&#8217;s presentation on Decision Making in Early Phase Clinical Development. \u00a0This talk was very well received by the delegates and prompted\u00a0plenty of discussion afterwards.<\/p>\n<p><!--more--><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-4748\" src=\"https:\/\/cytel.agencyukdev.com\/wp-content\/uploads\/2024\/06\/PaulFrewer.webp\" alt=\"\" width=\"860\" height=\"483\" srcset=\"https:\/\/cytel.agencyukdev.com\/wp-content\/uploads\/2024\/06\/PaulFrewer.webp 860w, https:\/\/cytel.agencyukdev.com\/wp-content\/uploads\/2024\/06\/PaulFrewer-300x168.webp 300w, https:\/\/cytel.agencyukdev.com\/wp-content\/uploads\/2024\/06\/PaulFrewer-473x266.webp 473w\" sizes=\"auto, (max-width: 860px) 100vw, 860px\" \/><\/p>\n<p><strong>Creating a Decision- Making Framework<\/strong><\/p>\n<p>Frewer presented engagingly about \u00a0how Astrazeneca have developed and implemented an\u00a0evidence based\u00a0decision making framework within their\u00a0early phase clinical development group. The approach (based on a methodology proposed by Lalonde, et al)\u00a0was designed to\u00a0enable the organisation\u00a0to take forward the best compounds within a candidate rich, early phase portfolio. Frewer, et al&#8217;s\u00a0paper\u00a0<strong><a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pst.1746\/abstract\">Decision Making in Early Clinical\u00a0Drug\u00a0Development <\/a><\/strong>on the topic\u00a0is\u00a0published in <strong>Pharmaceutical Statistics\u00a0<\/strong>and available online.<\/p>\n<p>&nbsp;<\/p>\n<p>The development of a\u00a0consistent approach to quantitative decision-making means that studies are designed from the outset with the decision in mind. \u00a0Importantly, once results are available they are interpreted against a\u00a0pre-determined framework, allowing clear decisions to be made more quickly.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>3 outcome framework<\/strong><\/p>\n<p>This is a 3 outcome decision framework which includes Go, Stop\u00a0and Consider.<\/p>\n<p>In order to implement the decision framework the following decision parameters are required:<\/p>\n<ul>\n<li>Target Value (TV) &#8211; or the desired level of performance<\/li>\n<li>Lower reference value (LRV) &#8211; the minimal level of performance<\/li>\n<li>False Stop Risk- Risk of a stop if the truth is better than TV<\/li>\n<li>False Go Risk -Risk of a go if the truth is worse than the LRV<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>The LRV and TV need to be scientifically justified, ideally from the Target Product Profile. Based on the input decision parameters, a standard decision plot is created to take to governance committees.<\/p>\n<p>Where the outcome is in the Stop or Go zone, naturally the decision is clear. If the outcome is in the Consider zone, then decision criteria should also be developed on how to move out of this zone. \u00a0For example, these criteria may be based on a secondary endpoint or using competitor data on a similar compound.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Future Implementation<\/strong><\/p>\n<p>While the framework has initially been developed in a Frequentist setting, the approach lends itself well to\u00a0a Bayesian setting.\u00a0\u00a0Indeed, a custom software is now in final stages of development to take forward, and apply in\u00a0both\u00a0environments.<\/p>\n<p>Importantly, Frewer noted that in early clinical development the approach was now &#8220;all about the decision&#8221; and not necessarily about P values. \u00a0He highlighted the key role to be played by the statistician in this decision making process \u2014 ensuring that the TV and LRV are evidence based, generating the operating characteristics as well as consulting on improving the operating characteristics and use of interim analyses to investigate decision timings.<\/p>\n<p>One\u00a0of the \u00a0advantages of Astrazeneca&#8217;s\u00a0approach which really resonated with the audience at the EUGM was that the framework provides a common basis for communication \u00a0for the different stakeholders within a clinical study team.\u00a0<span style=\"font-size: 1rem; background-color: transparent;\">\u00a0<\/span><\/p>","protected":false},"featured_media":3105,"parent":0,"template":"","meta":{"_acf_changed":false},"tags":[76],"by-topic":[429,434,250,413,435],"by-year":[507],"class_list":["post-3162","perspectives","type-perspectives","status-publish","has-post-thumbnail","hentry","tag-blog","by-topic-adaptive-clinical-trials","by-topic-bayesian-methods","by-topic-phase-1","by-topic-phase-2","by-topic-software","by-year-507"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Decision Making in Early Clinical Development - Clinical Trial Software &amp; Data Analysis | Cytel | Contact Us<\/title>\n<meta name=\"description\" content=\"Paul Frewer presented on Decision Making in Early Clinical Development and Cytel&#039;s East User Group Meeting in London March 2016\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cytel.com\/perspectives\/decision-making-in-early-clinical-development\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Decision Making in Early Clinical Development - Clinical Trial Software &amp; 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