{"id":3322,"date":"2018-05-11T14:44:56","date_gmt":"2018-05-11T14:44:56","guid":{"rendered":"https:\/\/blog.kolabtree.com\/?p=3322"},"modified":"2020-11-05T11:50:38","modified_gmt":"2020-11-05T11:50:38","slug":"how-to-design-a-clinical-trial-5-steps","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/","title":{"rendered":"How to Design a Clinical Trial: 5 Steps"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f20276a010f\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f20276a010f\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/#1_Make_it_simple\" title=\"1. Make it simple\">1. Make it simple<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/#2_Patient_and_associated_professionals_recruitment_is_a_key_determinant_of_success\" title=\"2. Patient and associated professionals recruitment is a key determinant of success\n\">2. Patient and associated professionals recruitment is a key determinant of success\n<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/#3_Plan_the_4_phases_with_the_goal_of_your_clinical_trial_in_mind\" title=\"3. Plan the 4 phases with the goal of your clinical trial in mind\">3. Plan the 4 phases with the goal of your clinical trial in mind<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/#4_Develop_an_adequate_budget_and_resources_plan\" title=\"4. Develop an adequate budget and resources plan\">4. Develop an adequate budget and resources plan<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/#5_Try_to_poke_holes_on_your_design_and_protocols\" title=\"5. Try to poke holes on your design and protocols\">5. Try to poke holes on your design and protocols<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\"><em>Hiring a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog_ClinicalTrial\">freelance clinical trials expert<\/a>\u00a0can be a cost-effective solution if you need to consult a qualified expert, on demand.<\/em><\/span><\/p>\n<p>In this post, <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/jesica-levingston-mac-leod\/?utm_source=Blog_ClinicalTrial\">Jesica Levingston Mac Leod<\/a>, PhD-qualified scientist and Kolabtree freelancer, provides 5 steps to <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog_ClinicalTrial\">design a clinical tria<\/a>l successfully and take your product\/device to market.<\/p>\n<p>Congratulations! After years of <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a>, you finally have a lead drug\/device that can take the leap of faith and start the clinical trial process. The appropriate design of this trial can help you<span style=\"font-weight: 400;\">\u00a0reach a successful outcome and delivering your drug\/device to the rest of the world. Here are some simple and very important steps to keep in mind when you&#8217;re going to design a\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog_ClinicalTrial\">clinical trial<\/a>.\u00a0<\/span><\/p>\n<h4><span class=\"ez-toc-section\" id=\"1_Make_it_simple\"><\/span><span style=\"font-weight: 400;\"><strong>1. Make it simple<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">Aim to answer only one question and\/or formulate only one hypothesis. Limit the protocol complexity to its minimum. Build up the project from the big picture to the smaller parts. Things will get complicated, indeed fulfilling all the regulatory protocols is quite complex and for this be sure to<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog_ClinicalTrial\"> hire the best professionals<\/a> you can find. Have in mind that you need to send the data to the Food and Drug Administration (FDA), or your local equivalent, for approval to continue research and testing before starting any of the 4 phases of clinical trials. <\/span><\/p>\n<h4><span class=\"ez-toc-section\" id=\"2_Patient_and_associated_professionals_recruitment_is_a_key_determinant_of_success\"><\/span><span style=\"font-weight: 400;\"><strong>2. Patient and associated professionals recruitment is a key determinant of success<\/strong><br \/>\n<\/span><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">The correct identification and engagement of a diverse group of stakeholders, from investigators and sponsors to patients, and keeping constant open communication (including their input and representation on related committees) are the critical starting points. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Some tips:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Diminish procedures and activities that create additional work for sites and patients. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Identify and eliminate items that are not necessary for ensuring safety of participants and keep the ones directly relevant to answering the primary research question. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Choose and report the methods of randomization correctly. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Seek for the cutting edge stratification methods. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Balance the study group using the stratification technique. At least, outcomes evaluation should be blinded. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Collect only the data necessary to maintain participant safety and address the main question. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Develop a plan to regularly meet with the stakeholders. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Schedule timely meetings to examine recruitment successes and challenges and ask sites if they need support to guaranty efficient and effective recruitment. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Create a short survey for persons offered enrollment but who decline to participate. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Choose the best key opinion leaders and professionals that you can find, if they can\u2019t join you, ask for referrals to find the best second option. <\/span><\/li>\n<li><span style=\"font-weight: 400;\">Create a diverse group, include marketing, regulators, medical doctors, scientist, executives, etc, and educate them on each other\u2019s roles and duties.<\/span><\/li>\n<\/ul>\n<h4><span class=\"ez-toc-section\" id=\"3_Plan_the_4_phases_with_the_goal_of_your_clinical_trial_in_mind\"><\/span><span style=\"font-weight: 400;\"><strong>3. Plan the 4 phases with the goal of your clinical trial in mind<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">In <\/span><b>Phase I<\/b><span style=\"font-weight: 400;\"> the studies shall assess the safety of a drug\/device, it might include a small number of healthy volunteers (20 to 100), with the aim to determine the effects of the drug\/device, like how it is absorbed, metabolized, and excreted, and possible side effects that occur as dosage levels are increased. <\/span><\/p>\n<p><b>In Phase II<\/b><span style=\"font-weight: 400;\">\u00a0the study must test the efficacy of a drug\/device. Most phase II studies are randomized trials; it is preferable if the study is &#8220;blinded&#8221; as this allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. <\/span><\/p>\n<p><b>In Phase III<\/b><span style=\"font-weight: 400;\">\u00a0the studies involve randomized and blind testing in hundred to several thousand patients, this provides both the company and the FDA with data on the effectiveness of the drug\/device, the benefits and the range of possible adverse reactions. Very importantly, once Phase III is complete, the company can request FDA approval for marketing the drug.<\/span><\/p>\n<p><b>In Phase IV<\/b><span style=\"font-weight: 400;\">\u00a0or Post Marketing Surveillance Trial, the aim is to compare a drug\/device with other drugs\/devices already in the market; to monitor a drug&#8217;s long-term effectiveness and impact on a patient&#8217;s quality of life; and to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. <\/span><\/p>\n<h4><span class=\"ez-toc-section\" id=\"4_Develop_an_adequate_budget_and_resources_plan\"><\/span><span style=\"font-weight: 400;\"><strong>4. Develop an adequate budget and resources plan<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">Create milestones and a way to keep the cost on track. Find the best way to measure the performance, remember: <\/span><strong>If you can&#8217;t measure it,\u00a0you can&#8217;t improve it.<\/strong><\/p>\n<h4><span class=\"ez-toc-section\" id=\"5_Try_to_poke_holes_on_your_design_and_protocols\"><\/span><span style=\"font-weight: 400;\"><strong>5. Try to poke holes on your design and protocols<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h4>\n<p><span style=\"font-weight: 400;\">Run an environmental scan or SWOT (strengths, weaknesses, opportunities, threats) analysis, include competition, policy, seasonal fluctuations, awareness, disease stage and rarity, satisfaction with current therapies, and economic concerns. Anticipate unwanted events to identify potential pitfalls and bottlenecks, you can use historic and bench-marked data to estimate realistic timelines. A bulletproof clinical trial design has to be tested in the most inconvenient ways in order to be more secure and safe.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The take home message is that a clinical trail designed with a clear aim, milestones and timeline, by a team of diverse and knowledgeable professionals, working in open and safe environments, where ideas and feedback are welcome can help you to expedite and improve the process to bring your drug\/device to the market and change the world.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">References:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S155171441730753X\"><span style=\"font-weight: 400;\">https:\/\/www.sciencedirect.com\/science\/article\/pii\/S155171441730753X<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5594116\/\"><span style=\"font-weight: 400;\">https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5594116\/<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\"><a href=\"https:\/\/www.centerwatch.com\/clinical-trials\/overview.aspx\"><span style=\"font-weight: 400;\">https:\/\/www.centerwatch.com\/clinical-trials\/overview.aspx<\/span><\/a><\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>&#8212;&#8212;&#8211;<br \/>\nNeed help to design a clinical trial? Consult a\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog_ClinicalTrial\">clinical trials expert<\/a> on Kolabtree. Post a project and get quotes for free.<\/p>\n<p><span style=\"font-weight: 400;\">Related Experts:<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/services\/clinical-research-consulting?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Clinical research consultants<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biotechnology?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Biotechnology<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Biostatistics<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/bioinformatics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Bioinformatics<\/a>| <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trial-protocols\">Clinical trial protocols<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report--cer\">Clinical evaluation writing<\/a> | <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Medical device consulting<\/a> | <a href=\"http:\/\/www.kolabtree.com\/find-an-expert\/subject\/genetics-and-genomics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrial\">Genetics and Genomics\u00a0<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hiring a freelance clinical trials expert\u00a0can be a cost-effective solution if you need to consult a qualified expert, on demand. In this post, Jesica Levingston Mac Leod, PhD-qualified scientist and Kolabtree freelancer, provides 5 steps to design a clinical trial successfully and take your product\/device to market. Congratulations! After years of research, you finally have<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":57,"featured_media":3354,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,247,443,435],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How to Design a Clinical Trial: Five Steps - Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Five steps that can help you design a clinical trial, so that you can take your drug or device confidently to the rest of the world.\" \/>\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.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"How to Design a Clinical Trial: 5 Steps\" \/>\n<meta property=\"og:description\" content=\"Five steps that can help you design a clinical trial, so that you can take your drug or device confidently to the rest of the world.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/how-to-design-a-clinical-trial-5-steps\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2018-05-11T14:44:56+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-11-05T11:50:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2018\/05\/TWITTER-ADS-ASPECT-RATIO-8.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Jesica Levingston Mac Leod\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jesica Levingston Mac Leod\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"How to Design a Clinical Trial: Five Steps - 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She was a postdoctoral researcher at Mount Sinai School of Medicine in New York in the department of Microbiology. Since 2015 she has been a consultant and Project manager for an image analysis international company focus in immuno-oncology (acquired by AstraZeneca). She contributed to several blogs, journals, books, articles and websites as content writer and editor. 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