{"id":3230,"date":"2024-06-10T11:22:36","date_gmt":"2024-06-10T15:22:36","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/myth-busting-master-protocol-edition\/"},"modified":"2024-08-22T05:53:53","modified_gmt":"2024-08-22T09:53:53","slug":"myth-busting-master-protocol-edition","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/myth-busting-master-protocol-edition\/","title":{"rendered":"Myth Busting: Master Protocol Edition"},"content":{"rendered":"<p>Interest and appetite for <a href=\"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/understanding-master-protocol-designs-platform-and-basket-trials\/\">master protocols<\/a> is growing as sponsors consider opportunities in various therapeutic areas beyond oncology. During initial discussions, most quickly recognize the potential operational and inferential benefits of a master protocol; however, as sponsors dive deeper into the details, doubt creeps in and there are a multitude of reasons expressed for not moving forward with a master protocol. Here are some common myths and the facts around them:<\/p>\n<p><!--more--><\/p>\n<p><strong>Myth:<\/strong> Master protocols only work in <a href=\"https:\/\/cytel.agencyukdev.com\/fr\/solutions\/specialty-areas\/oncology\/\">oncology<\/a>.<\/p>\n<p><strong>Fact:<\/strong> While master protocols started in oncology, it is a growing field with examples of platform, basket, and umbrella trials used in many other therapeutic areas, including studies on Type 1 diabetes, Alzheimer\u2019s disease, chronic pain, and more.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Myth:<\/strong> Master protocols are impossible to operationalize and implement.<\/p>\n<p><strong>Fact:<\/strong> Master protocols have been in use for over a decade. There are unique operational challenges to master protocols, but risk mitigation can help to minimize the impact.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Myth:<\/strong> Evaluation of design characteristics is difficult or impossible.<\/p>\n<p><strong>Fact:<\/strong> Simulation can be used to obtain design characteristics and gain valuable insight into various challenges that may be encountered.<\/p>\n<p>&nbsp;<\/p>\n<p>There are many myths around master protocols, but many of these can be dispelled. More than a decade of experience, tools, aids, and literature can help lower the steep learning curve for groups new to master protocols, though development of a master protocols requires careful cross-functional team collaboration, which may not be native to some groups.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Interested in learning more about master protocols?<\/strong> <a href=\"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/platform-trials-master-protocols-and-challenges-in-execution\/\">Watch<\/a> my webinar on &#8220;Platform trials, master protocols, and the challenges in execution&#8221;<\/p>\n<p>&nbsp;<\/p>","protected":false},"featured_media":3713,"parent":0,"template":"","meta":{"_acf_changed":false},"tags":[76],"by-topic":[429,461],"by-year":[73],"class_list":["post-3230","perspectives","type-perspectives","status-publish","has-post-thumbnail","hentry","tag-blog","by-topic-adaptive-clinical-trials","by-topic-master-protocol","by-year-73"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Myth Busting: Master Protocol Edition - Clinical Trial Software &amp; 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