{"id":3166,"date":"2024-06-10T11:22:31","date_gmt":"2024-06-10T15:22:31","guid":{"rendered":"https:\/\/cytel.agencyukdev.com\/perspectives\/design-considerations-for-early-phase-trials-of-immuno-oncology-drugs\/"},"modified":"2024-08-21T12:04:35","modified_gmt":"2024-08-21T16:04:35","slug":"design-considerations-for-early-phase-trials-of-immuno-oncology-drugs","status":"publish","type":"perspectives","link":"https:\/\/cytel.agencyukdev.com\/fr\/perspectives\/design-considerations-for-early-phase-trials-of-immuno-oncology-drugs\/","title":{"rendered":"Design Considerations for Early Phase Trials of Immuno-oncology Drugs"},"content":{"rendered":"<p>Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.<\/p>\n<p>Hastening the search for novel treatment options therefore benefits from exploration of how these complex early and late-phase designs interact with each other, and what special design considerations can be implemented in early phases of clinical research for strategic late-phase clinical development. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:<!--more--><\/p>\n<ul>\n<li>Which dose-escalation designs are best suited for trials where the new treatment aspires to join a basket trial in later phases?<\/li>\n<li>Is data acquired using a complex early phase design like BLRM, TITE-BOIN, or dual-agent escalation recommended for use if a seamless design will thereafter be used to confirm efficacy?<\/li>\n<li>What are the adaptive strategies that best serve specific trials?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>A recent webinar by Cytel&#8217;s Michael Fossler and James Matcham reviews the various trial design considerations confronting modern immunotherapy sponsors. After introducing the relative benefits of a number of algorithm-based and model-based escalation designs, Fossler and Matcham dive into strategic uses of target population, clinical pharmacology considerations, and exposure-response modeling for efficient clinical development.<\/p>\n<p>Taken together, these questions can help sponsors have more in-depth conversations with their statistical design consultants about specific adaptive design and modeling strategies for their immunotherapies.<\/p>\n<p>&nbsp;<\/p>\n<p>Bayesian topics are frequently featured in Cytel&#8217;s Perspectives on Enquiry and Evidence. Our new <a href=\"https:\/\/cytel.agencyukdev.com\/fr\/resource\/topics-in-bayesian-statistical-methods\/\" target=\"_blank\" rel=\"noopener\">eBook<\/a> features a set of articles exploring various topics related to Bayesian statistical methods.<\/p>\n<p style=\"font-weight: bold;\">","protected":false},"featured_media":3105,"parent":0,"template":"","meta":{"_acf_changed":false},"tags":[76],"by-topic":[429,434,436],"by-year":[73],"class_list":["post-3166","perspectives","type-perspectives","status-publish","has-post-thumbnail","hentry","tag-blog","by-topic-adaptive-clinical-trials","by-topic-bayesian-methods","by-topic-oncology","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>Design Considerations for Early Phase Trials of Immuno-oncology Drugs - Clinical Trial Software &amp; Data Analysis | Cytel | Contact Us<\/title>\n<meta name=\"description\" content=\"Webinar: Fossler and Matcham outline available dose-escalation designs and Basket designs that investigate biomarker-defined patient populations.\" \/>\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\/design-considerations-for-early-phase-trials-of-immuno-oncology-drugs\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Design Considerations for Early Phase Trials of Immuno-oncology Drugs - Clinical Trial Software &amp; 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