{"id":4173,"date":"2019-07-18T15:00:41","date_gmt":"2019-07-18T19:00:41","guid":{"rendered":"https:\/\/advmedtechconf.wpengine.com\/?p=4173"},"modified":"2019-07-18T15:53:27","modified_gmt":"2019-07-18T19:53:27","slug":"factors-clinical-trial","status":"publish","type":"post","link":"https:\/\/themedtechconference.com\/factors-clinical-trial\/","title":{"rendered":"Four Critical Factors for Clinical Trial Budget Success"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><em>By Chris Rao, Director, Alira Health Clinical<\/em>  <\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignleft is-resized\"><img decoding=\"async\" src=\"https:\/\/advmedtechconf.wpengine.com\/wp-content\/uploads\/ah-logo-staticversionb-1024x205.png\" alt=\"\" class=\"wp-image-4174\" width=\"340\" height=\"68\" srcset=\"https:\/\/themedtechconference.com\/wp-content\/uploads\/ah-logo-staticversionb-1024x205.png 1024w, https:\/\/themedtechconference.com\/wp-content\/uploads\/ah-logo-staticversionb-200x40.png 200w, https:\/\/themedtechconference.com\/wp-content\/uploads\/ah-logo-staticversionb-400x80.png 400w, https:\/\/themedtechconference.com\/wp-content\/uploads\/ah-logo-staticversionb-768x154.png 768w, https:\/\/themedtechconference.com\/wp-content\/uploads\/ah-logo-staticversionb.png 2000w\" sizes=\"(max-width: 340px) 100vw, 340px\" \/><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Planning\na relevant and accurate budget, regardless of the trial phase or indication, can\nbe one of the most challenging aspects of the clinical trial process. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Though\nit is one of the most integral and essential components of the program,\nclinical trial budgets are often overly bulky, missing fine details or just\nplain inaccurate. This results in the need to re-forecast and re-plan, delay or\neven close a trial due to insufficient or improperly allocated funds. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">How\ncan you ensure your clinical trial budget is airtight? By taking a realistic\napproach to clinical trial budget planning and execution. Consider these four\nfactors when developing your budget:&nbsp; <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Be realistic<\/strong><strong>:<\/strong>\nUnrealistic timelines and cost ceilings are frequently pushed down from the\ntop. Understand where you can shave time (and costs) off your trial plan and\nwhere it is simply not possible. A realistic view of costs, though sometimes\npainful, will help you plan for the necessities of the trial and will avoid\n\u201cwishful thinking\u201d. Examples of timelines which can only be minimally shifted\nare institutional startup timelines (such as IRB review) and regulatory\ntimelines set by FDA or other agencies.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Understand your indication:<\/strong> Each indication is unique as it relates to subject accrual, institutional reimbursement and standard of care vs. protocol-required procedures. By having a firm grasp on the nuances of your patient population, you will be better equipped to estimate subject costs, institutional fees and enrollment rates at the site level, all of which have a direct budgetary impact.<\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Look for hidden costs: <\/strong>Sponsor companies\nare often plagued by \u201chidden\u201d costs, such as clinical equipment rentals and\nunanticipated invoiceable study procedures at the site level, as well as study\ndelays and other timeline changes which increase costs. Plan for the unexpected\nby building a cushion into your trial budget. Some sponsor companies will\nincrease study-wide costs by a 5-10% margin, ensuring that an unanticipated\ndelay or increased cost is not a budget-breaker. <\/li><\/ul>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Compare Service Providers:<\/strong> Not all service providers are created equally. When budgeting for items such as data management, clinical site monitoring and pharmacovigilance, your chosen service provider should be able to provide you with a clear, concise and understandable explanation of projected charges. While change orders are sometimes a necessary evil, a good service provider should ensure that these are the exception, rather than the norm. <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Taking\na practical and measured approach to clinical trial budgeting will help you\nbuild an initial trial budget that is as accurate as possible and provide some cushion\nto help weather unexpected storms that may pop up during your trial. With these\nfactors in mind, you\u2019ll be well on your way to success, without breaking the\nbank (or your budget). <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Chris Rao is the Director of Alira Health Clinical. Chris has over 15 years of experience in clinical research, with a focus on trial design and management. For more information, please visit <a href=\"https:\/\/www.alirahealth.com\">www.alirahealth.com<\/a> or contact Chris at <a href=\"mailto:chris.rao@alirahealth.com\">chris.rao@alirahealth.com<\/a>. <\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Chris Rao, Director, Alira Health Clinical Planning a relevant and accurate budget, regardless of the trial phase or indication, can be one of the most challenging aspects of the clinical trial process. Though it is one of the most &#8230; <\/p>\n<p class=\"read-more-container\"><a title=\"Four Critical Factors for Clinical Trial Budget Success\" class=\"read-more button\" href=\"https:\/\/themedtechconference.com\/factors-clinical-trial\/#more-4173\">Keep Reading<span class=\"screen-reader-text\">Four Critical Factors for Clinical Trial Budget Success<\/span><\/a><\/p>\n","protected":false},"author":32,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-4173","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Four Critical Factors for Clinical Trial Budget Success - The MedTech Conference<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/themedtechconference.com\/factors-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Four Critical Factors for Clinical Trial Budget Success - The MedTech Conference\" \/>\n<meta property=\"og:description\" content=\"By Chris Rao, Director, Alira Health Clinical Planning a relevant and accurate budget, regardless of the trial phase or indication, can be one of the most challenging aspects of the clinical trial process. 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