{"id":17984,"date":"2018-08-21T09:41:08","date_gmt":"2018-08-21T09:41:08","guid":{"rendered":"https:\/\/strammer.com\/?p=17984"},"modified":"2018-08-21T09:41:08","modified_gmt":"2018-08-21T09:41:08","slug":"3-reasons-clinical-trials-fail","status":"publish","type":"post","link":"https:\/\/strammer.com\/es\/3-reasons-clinical-trials-fail\/","title":{"rendered":"3 Reasons Why Clinical Trials Fail"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-fullwidth-1  fusion-parallax-none nonhundred-percent-fullwidth\" style=\"border-bottom-width: 0px;border-top-width: 0px;border-bottom-style: solid;border-top-style: solid;padding-bottom:20px;padding-top:20px;padding-left:;padding-right:;\"><style type=\"text\/css\" scoped=\"scoped\">.fusion-fullwidth-1 {\r\n                            padding-left: px !important;\r\n                            padding-right: px !important;\r\n                        }<\/style><div class=\"fusion-row\"><div class=\"fusion-title title fusion-title-center fusion-title-size-one\"><div class=\"title-sep-container title-sep-container-left\"><div class=\"title-sep sep-double sep-solid\" style=\"border-color:#a36160;\"><\/div><\/div><h1 class=\"title-heading-center\"><span style=\"color: #a36160;\">3 Reasons Why Clinical Trials Fail<\/span><\/h1><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep-double sep-solid\" style=\"border-color:#a36160;\"><\/div><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep sep-none\" style=\"margin-left: auto;margin-right: auto;margin-top:;\"><\/div><p style=\"text-align: justify;\">Clinical trials are used to test how <strong>novel treatments compare<\/strong> with already existing treatments or their <strong>potential to cure<\/strong> a new disease. The main goal of medication is the significant <strong>impact on patient care<\/strong>, which requires several test phases to ensure that this goal is achieved. However, not all clinical trials end up like planned.<\/p>\n<p style=\"text-align: justify;\">To start with, there are <strong>two dimensions<\/strong> why clinical trials fail. Firstly, <strong>project failures<\/strong> can be a reason, which includes <strong>budget<\/strong>, project <strong>targets<\/strong> and <strong>deadlines<\/strong> that must be met. The second dimension is <strong>research failure<\/strong>, for example not being able to reach <strong>statistical significance<\/strong> in a research area. Within those dimensions, there are basic principles that must be paid attention to.<\/p>\n<p style=\"text-align: justify;\"><em>What are these main aspects that can cause failures in clinical trials?<\/em><\/p>\n<p style=\"text-align: justify;\">One reason for failures are <strong>molecules that don\u2019t work<\/strong>. This means, that the molecule either doesn\u2019t have enough <strong>biological activity<\/strong> or doesn\u2019t have <strong>manageable toxicity<\/strong>. In some cases, we can find no biological activity at all, whereas in others there is some, but the effects are not like expected. In addition to that, <strong>every molecule has toxicity<\/strong> in it that the trialist has to <strong>design around<\/strong>. The problem here is not the toxicity itself, but rather if it has <strong>unpredictable effects<\/strong>.<\/p>\n<p style=\"text-align: justify;\">Moreover, another cause for clinical trial failures is the <strong>inability to meet predetermined timelines or criteria<\/strong>. The FDA provides several rules and expectations for novel treatments, which some companies neglect. Those companies that do not meet the requirements from the FDA can <strong>risk their chance<\/strong> to get their treatment passed to later phase clinical studies. In consequence, this results in <strong>abandonment of the newly created medication<\/strong>.<\/p>\n<p style=\"text-align: justify;\">However, one of the most common reasons for failure are <strong>design issues<\/strong>. The most important variables for clinical trial design are the selection of the <strong>right patient<\/strong>, the <strong>right dosing<\/strong> and the <strong>right endpoint<\/strong>. The right endpoint matters to ensure that a new drug is of essence and shows the <strong>desired effects<\/strong>. When a novel treatment goes to clinical trial, certain characteristics of a good endpoint must be checked. Characteristics, such as <strong>clinical relevance<\/strong>, <strong>reliability<\/strong>\u00a0and\u00a0<strong>robustness to dropouts<\/strong>\u00a0&amp;\u00a0<strong>missing data<\/strong>.<\/p>\n<p style=\"text-align: justify;\">Secondly, the <strong>right dose<\/strong>, such as <strong>amount of an intervention<\/strong>, <strong>route of administration<\/strong>, <strong>interval dosing<\/strong> and the <strong>duration of administration<\/strong> play an important role. The most common mistake with dosing is selecting a dose that is <strong>too high or too low<\/strong>. This case can occur, when previous studies weren\u2019t thorough enough to collect <strong>sufficient data<\/strong>.<\/p>\n<p style=\"text-align: justify;\">The last parameter for a good endpoint is the <strong>right patient<\/strong>. Patients that are <strong>physically incapable of responding<\/strong> to the treatment result in <strong>poor patient selection<\/strong>. It\u2019s vital to think through the disease you want to cure and maybe even <strong>expand the trial<\/strong>, in order to check all disease categories that are relevant.<\/p>\n<p style=\"text-align: justify;\">There are many reasons for clinical trial failure and those are <strong>just 3 of them<\/strong>. All in all, test periods for novel medications take a long time and precise analysis of various criteria. In order to <strong>successfully pass all test phases<\/strong> of a clinical trial, many aspects <strong>must be considered<\/strong> and <strong>thought through carefully<\/strong>.<\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 10pt;\">For examples of clinical trial fails from the year 2017, <a href=\"https:\/\/www.genengnews.com\/the-lists\/unlucky-13-top-clinical-trial-failures-of-2017\/77901028\" target=\"_blank\" rel=\"noopener noreferrer\">click here.<\/a><\/span><\/p>\n<div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep sep-none\" style=\"margin-left: auto;margin-right: auto;margin-top:;\"><\/div><p><span style=\"text-decoration: underline; color: #b2999d;\">References:<\/span><\/p>\n<ul>\n<li style=\"text-align: justify;\">Chris Palford (July 8, 2015). Why Do Most Clinical Trials Fail. Available at: <em>https:\/\/www.clinicalleader.com\/doc\/why-do-most-clinical-trials-fail-0001<\/em><\/li>\n<li style=\"text-align: justify;\">Richard Chin (November 13, 2017). Why Clinical Trials Fail. Available at: <em>https:\/\/clinicaltrialist.com\/2017\/11\/13\/why-clinical-trials-fail\/<\/em><\/li>\n<li style=\"text-align: justify;\">Artem Andrianov. (May 2, 2015). 7 Reasonst Why Clinical Trials Fail. Available at: <em>https:\/\/cyntegrity.com\/7-reasons-clinical-trials-fail\/<\/em><\/li>\n<\/ul>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":17988,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","myguten_meta_block_field":"","footnotes":""},"categories":[98],"tags":[],"class_list":["post-17984","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/posts\/17984","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/comments?post=17984"}],"version-history":[{"count":0,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/posts\/17984\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/media\/17988"}],"wp:attachment":[{"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/media?parent=17984"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/categories?post=17984"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/strammer.com\/es\/wp-json\/wp\/v2\/tags?post=17984"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}