{"id":455,"date":"2018-04-26T08:52:46","date_gmt":"2018-04-26T08:52:46","guid":{"rendered":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist\/"},"modified":"2025-11-25T13:14:42","modified_gmt":"2025-11-25T07:44:42","slug":"3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","status":"publish","type":"post","link":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","title":{"rendered":"3 Signs of poorly designed clinical trial protocol [Includes research protocol checklist]"},"content":{"rendered":"<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">\u00a0 The foundation of every clinical trial is a clinical protocol. It is an important document that describes in detail all the crucial elements of the research. In fact, having a clear and well-designed clinical trial protocol is essential before the initiation of a clinical trial. Some of the purposes the protocol serves are:<\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\">It guides the principal investigator by providing him\/her an official record of the procedure that needs to be followed during the clinical trial<sup>1<\/sup>.<\/li>\n<li class=\"CxSpMiddle\" style=\"text-align: justify;\">It apprises the study participants of the exhaustive illustration of the trial procedures and methodology<sup>2<\/sup>.<\/li>\n<li class=\"CxSpMiddle\" style=\"text-align: justify;\">It informs the independent ethics committee\/institutional review board that the study conforms to the ethical standards for clinical research<sup>1<\/sup>.<\/li>\n<li class=\"CxSpMiddle\" style=\"text-align: justify;\">It helps the sponsors who are investing in the study to estimate the overall effort required for the trial and foresee if the trial is feasible<sup>5<\/sup>.<\/li>\n<\/ul>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">As the protocol is essentially the roadmap for everyone involved in the study, it should be written succinctly and clearly. Despite the requirements for a well-designed protocol, many of the protocols that we come across are poorly designed. This is because many authors find it challenging to write the protocol. In this article, I will discuss the common mistakes that authors make when writing protocols. They are listed below: \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<\/span><\/span><\/span><\/p>\n<p class=\"CxSpMiddle\" style=\"text-align: justify;\"><b>1. Unclear specification of the sponsor and investigator responsibility <\/b><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">A clear outlining of the sponsor and investigator responsibilities is one of the basic requirements of clinical trial protocols. However, it is commonly observed that many protocols fail to do this<sup>3<\/sup>. If the sponsor and investigator responsibilities are not meticulously outlined, there may be delays in initiating the study and conducting the trial. Investigators oversee the regulation of proper handling, stockpiling, and obliterating of the new drug under study<sup>4<\/sup>. <\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Similarly, sponsors oversee quality control to ensure that the trial is conducted and data is generated according to the protocol<sup>5<\/sup>. If the protocol lacks clear specification of the sponsor and investigator responsibility, the resulting protocol will not ensure proper and safe use of the new drug during the trial. <\/span><\/span><\/span><\/p>\n<p class=\"CxSpMiddle\" style=\"text-align: justify;\"><b>2. Lack of methodological details <\/b><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Methodology forms a crucial part of the protocol. One of the indicators of a poorly designed protocol is the lack of methodological details, such as missing out on reporting the primary outcomes and power calculations that determine the test\u2019s statistical significance<sup>6,7<\/sup>. <\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Hence the content of clinical trial protocol should include methodological insights regarding test size, while the full investigation ought to be reported in the trial. It is only with a clear reporting of the methodological details that the study can be considered reliable and safe. <\/span><\/span><\/span><\/p>\n<p class=\"CxSpMiddle\" style=\"text-align: justify;\"><b>3. Unclear allocation concealment<\/b><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">A poorly designed trial can be potentially misleading and lead to biases in the study<sup>8<\/sup>. Randomization is, therefore, done with the intent to prevent bias from creeping in by distributing subjects into two study arms without any knowledge of their medical condition<sup>8<\/sup>. This means the medical condition of the subjects needs to be concealed from the person who oversees the allocation. <\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Many protocols do not provide sufficient details about the allocation concealments. Hence to make the trial reliable its protocol should ensure that details about allocation concealments are clearly provided.<\/span><\/span><\/span><\/p>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Clinical trials are vital to testing the efficacy and safety of new treatment methods. Therefore, chalking out a detailed protocol is of extreme importance. Admittedly, this can be a complex and long drawn process, but avoiding the above-mentioned mistakes while developing the trial protocol will help in enhancing the reliability of a clinical trial results for a new drug or treatment method.\u00a0 <\/span><\/span><\/span><\/p>\n<table style=\"width: 500px;\" border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\n<thead>\n<tr>\n<th scope=\"col\">\n<div class=\"WordSection1\">\n<p style=\"margin: 0in 0in 8pt;\"><span style=\"page: WordSection1;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\"><span lang=\"EN-IN\" style=\"font-size: 10.0pt;\" xml:lang=\"EN-IN\"><span style=\"font-family: 'Segoe UI',sans-serif;\"><span style=\"color: black;\">Research Protocol Checklist <\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/p>\n<\/div>\n<ol>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Background and rationale &#8211; the main reasons for conducting the clinical trial<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Objectives &#8211; the critical questions the research study addresses<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Informed consent &#8211; the consent from participants<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Subject selection criteria &#8211;\u00a0inclusion and exclusion criteria<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Treatment plan and study procedures &#8211; research method\u00a0<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Statistical analysis plan &#8211; how data and information will be processed<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Assessment of safety and efficacy &#8211; listing of any risks<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">Anticipated results and study limitations \u00a0\u00a0<\/span><\/span><\/span><\/li>\n<\/ol>\n<p style=\"margin: 0in 0in 8pt; text-align: left;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><i>(Reference: <\/i><i style=\"color: #0563c1; text-decoration: underline;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/a-young-researchers-guide-to-a-clinical-trial\/\">A young researcher&#8217;s guide to a clinical trial<\/a>)<\/i><\/span><\/span><\/span><\/p>\n<\/th>\n<\/tr>\n<\/thead>\n<\/table>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><b>Related reading:<\/b><\/span><\/span><\/span><\/p>\n<ul>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/a-young-researchers-guide-to-a-clinical-trial\/\">A young researcher&#8217;s guide to a clinical trial<\/a><\/span><\/span><\/span><\/li>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/?post_type=slideshare&amp;p=5064\">An introduction to clinical trials (Part 1: The basics)<\/a><\/span><\/span><\/span><\/li>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/an-introduction-to-clinical-trials-part-2-things-to-remember\/\">An introduction to clinical trials (Part 2: Things to remember)<\/a><\/span><\/span><\/span><\/li>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/what-every-medical-researcher-should-know-about-registering-clinical-trials\/\">What every medical researcher should know about registering clinical trials<\/a><\/span><\/span><\/span><\/li>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\"><a style=\"font-family: Calibri, sans-serif; font-size: 11pt; color: #0563c1;\" href=\"https:\/\/www.editage.com\/insights\/patient-peer-reviews-an-unorthodox-approach-to-clinical-trial-publication\/\">Patient peer reviews: An unorthodox approach to clinical trial publication<\/a><\/li>\n<li style=\"text-align: justify; margin: 0in 0in 8pt;\">\n<p style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.editage.com\/insights\/protecting-the-identity-of-enrolled-subjects-in-case-reports-and-clinical-trials\/\">Protecting the identity of enrolled subjects in case reports and clinical trials<\/a><\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"text-align: justify; margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><b>References: <\/b><\/span><\/span><\/span><\/p>\n<ol>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">ICH guidelines <a style=\"color: #0563c1; text-decoration: underline;\" href=\"http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R2__Step_4_2016_1109.pdf\">http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R2__Step_4_2016_1109.pdf<\/a><\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\"><span style=\"background: white;\">Kane JL, Wang J, Garrard J (2007) Reporting in randomised clinical trials improved after adoption of the CONSORT statement. J Clin Epidemiol 60: 241\u2013249.<\/span><\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">G\u00f8tzsche P, Hr\u00f8bjartsson A, Johansen H, Haahr M, Altman D, Chan A: Ghost\u00a0<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">authorship in industry-initiated randomised trials. PLoS Med 2007, 4:e19.<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">doi:10.1371\/journal.pmed.0040019.<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 16pt;\"><span style=\"background: white;\"><span style=\"line-height: 16.2pt;\"><span style=\"font-family: 'Calibri Light',sans-serif;\"><span style=\"color: null;\"><span style=\"font-weight: normal;\"><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\"><span style=\"background: white;\"><span style=\"font-family: 'Calibri','sans-serif';\">Allison R. Baer, RN, BSN,\u00a0Susan Devine, CCRP,\u00a0Chris David Beardmore,\u00a0and\u00a0Robert Catalano,\u00a0<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><span style=\"font-size: 16pt;\"><span style=\"background: white;\"><span style=\"line-height: 16.2pt;\"><span style=\"font-family: 'Calibri Light',sans-serif;\"><span style=\"color: null;\"><span style=\"font-weight: normal;\"><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\"><span style=\"background: white;\"><span style=\"font-family: 'Calibri','sans-serif';\">PharmD:<\/span><\/span><\/span><b> <\/b><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\"><span style=\"font-family: 'Calibri','sans-serif';\">Clinical Investigator Responsibilities<b>.<\/b><\/span><\/span><\/span><\/span><span style=\"color: #2f5496;\"><span style=\"font-weight: normal;\"><b> <\/b><a style=\"color: #0563c1; text-decoration: underline;\" href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3051859\/\"><span style=\"font-size: 11.0pt;\"><span style=\"background: white;\"><span style=\"font-family: 'Calibri','sans-serif';\"><span style=\"text-decoration: none;\"><span style=\"text-underline: none;\">J Oncol Pract<\/span><\/span><\/span><\/span><\/span><\/a><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\"><span style=\"background: white;\"><span style=\"font-family: 'Calibri','sans-serif';\">. <\/span><\/span><\/span><\/span><\/span><span style=\"color: null;\"><span style=\"font-weight: normal;\"><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\"><span style=\"background: white;\"><span style=\"font-family: 'Calibri','sans-serif';\">2011 Mar; 7(2): 124\u2013128.<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">ICH guidelines for sponsors, <a style=\"color: #0563c1; text-decoration: underline;\" href=\"http:\/\/ichgcp.net\/5-sponsor\">http:\/\/ichgcp.net\/5-sponsor<\/a><\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 10pt;\"><span style=\"font-family: Calibri,sans-serif;\"><span lang=\"EN-IN\" style=\"font-size: 11.0pt;\" xml:lang=\"EN-IN\">Chan AW, Hr\u00f3bjartsson A, Haahr MT, G\u00f8tzsche PC, Altman DG: Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA. 2004, 291: 2457-2465.<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">Chan AW, Hr\u00f3bjartsson A, J\u00f8rgensen KJ, G\u00f8tzsche PC, Altman DG:\u00a0<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">Discrepancies in sample size calculations and data analyses reported in<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">randomised trials: comparison of publications with protocols. BMJ 2008,\u00a0<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">337:a2299.<\/span><\/span><\/span><\/li>\n<li style=\"margin: 0in 0in 8pt;\"><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">Pildal J, Chan AW, Hr\u00f3bjartsson A, Forfang E, Altman DG, G\u00f8tzsche PC:\u00a0<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: normal;\"><span style=\"text-autospace: none;\"><span style=\"font-family: Calibri,sans-serif;\">Comparison of descriptions of allocation concealment in trial protocols\u00a0<\/span><\/span><\/span><\/span><span style=\"font-size: 11pt;\"><span style=\"line-height: 107%;\"><span style=\"font-family: Calibri,sans-serif;\">and the published reports: cohort study. BMJ 2005, 330:1049.<\/span><\/span><\/span><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 The foundation of every clinical trial is a clinical protocol. It is an important document that describes in detail all the crucial elements of the research. In fact, having a clear and well-designed clinical trial protocol is essential before the initiation of a clinical trial. Some of the purposes the protocol serves are: It [&hellip;]<\/p>\n","protected":false},"author":618,"featured_media":33313,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[2418],"tags":[99],"new_categories":[],"new_tags":[],"series":[],"class_list":["post-455","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-research-ethics","tag-ethical-guidelines"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights<\/title>\n<meta name=\"description\" content=\"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols\" \/>\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.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights\" \/>\n<meta property=\"og:description\" content=\"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\" \/>\n<meta property=\"og:site_name\" content=\"Editage Insights\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/Editage\" \/>\n<meta property=\"article:published_time\" content=\"2018-04-26T08:52:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-25T07:44:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/06\/editage-insights-generic-banner.png\" \/>\n\t<meta property=\"og:image:width\" content=\"870\" \/>\n\t<meta property=\"og:image:height\" content=\"446\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Kalpataru Mukherjee\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@Editage\" \/>\n<meta name=\"twitter:site\" content=\"@Editage\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Kalpataru Mukherjee\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\"},\"author\":{\"name\":\"Kalpataru Mukherjee\",\"@id\":\"https:\/\/www.editage.com\/insights\/#\/schema\/person\/c6f3704ecb3e2f11a3c19266a461a6fd\"},\"headline\":\"3 Signs of poorly designed clinical trial protocol [Includes research protocol checklist]\",\"datePublished\":\"2018-04-26T08:52:46+00:00\",\"dateModified\":\"2025-11-25T07:44:42+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\"},\"wordCount\":922,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.editage.com\/insights\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp\",\"keywords\":[\"ethical guidelines\"],\"articleSection\":[\"Research Ethics\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\",\"url\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\",\"name\":\"Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights\",\"isPartOf\":{\"@id\":\"https:\/\/www.editage.com\/insights\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp\",\"datePublished\":\"2018-04-26T08:52:46+00:00\",\"dateModified\":\"2025-11-25T07:44:42+00:00\",\"description\":\"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols\",\"breadcrumb\":{\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage\",\"url\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp\",\"contentUrl\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp\",\"width\":656,\"height\":336},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.editage.com\/insights\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"3 Signs of poorly designed clinical trial protocol [Includes research protocol checklist]\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.editage.com\/insights\/#website\",\"url\":\"https:\/\/www.editage.com\/insights\/\",\"name\":\"Editage Insights\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/www.editage.com\/insights\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.editage.com\/insights\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.editage.com\/insights\/#organization\",\"name\":\"Editage Insights\",\"url\":\"https:\/\/www.editage.com\/insights\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.editage.com\/insights\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2024\/09\/editage-insights-logo-1-scaled.webp\",\"contentUrl\":\"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2024\/09\/editage-insights-logo-1-scaled.webp\",\"width\":2560,\"height\":324,\"caption\":\"Editage Insights\"},\"image\":{\"@id\":\"https:\/\/www.editage.com\/insights\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.facebook.com\/Editage\",\"https:\/\/x.com\/Editage\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.editage.com\/insights\/#\/schema\/person\/c6f3704ecb3e2f11a3c19266a461a6fd\",\"name\":\"Kalpataru Mukherjee\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.editage.com\/insights\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/e94c4bcd6906be8340d7661c53820bf83a816f99ad0bc082db1b3915bab1bd2b?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/e94c4bcd6906be8340d7661c53820bf83a816f99ad0bc082db1b3915bab1bd2b?s=96&d=mm&r=g\",\"caption\":\"Kalpataru Mukherjee\"},\"url\":\"https:\/\/www.editage.com\/insights\/kalpataru-mukherjee\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights","description":"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","og_locale":"en_US","og_type":"article","og_title":"Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights","og_description":"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols","og_url":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","og_site_name":"Editage Insights","article_publisher":"https:\/\/www.facebook.com\/Editage","article_published_time":"2018-04-26T08:52:46+00:00","article_modified_time":"2025-11-25T07:44:42+00:00","og_image":[{"width":870,"height":446,"url":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/06\/editage-insights-generic-banner.png","type":"image\/png"}],"author":"Kalpataru Mukherjee","twitter_card":"summary_large_image","twitter_creator":"@Editage","twitter_site":"@Editage","twitter_misc":{"Written by":"Kalpataru Mukherjee","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#article","isPartOf":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below"},"author":{"name":"Kalpataru Mukherjee","@id":"https:\/\/www.editage.com\/insights\/#\/schema\/person\/c6f3704ecb3e2f11a3c19266a461a6fd"},"headline":"3 Signs of poorly designed clinical trial protocol [Includes research protocol checklist]","datePublished":"2018-04-26T08:52:46+00:00","dateModified":"2025-11-25T07:44:42+00:00","mainEntityOfPage":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below"},"wordCount":922,"commentCount":0,"publisher":{"@id":"https:\/\/www.editage.com\/insights\/#organization"},"image":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage"},"thumbnailUrl":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp","keywords":["ethical guidelines"],"articleSection":["Research Ethics"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","url":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below","name":"Overcoming Poorly Designed Clinical Trials [Download Checklist] | Editage Insights","isPartOf":{"@id":"https:\/\/www.editage.com\/insights\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage"},"image":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage"},"thumbnailUrl":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp","datePublished":"2018-04-26T08:52:46+00:00","dateModified":"2025-11-25T07:44:42+00:00","description":"This article explains the common mistakes that authors make when writing clinical trial protocols, and includes a checklist of essential elements of research protocols","breadcrumb":{"@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#primaryimage","url":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp","contentUrl":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2025\/02\/editage-insights-generic-banner_298.webp","width":656,"height":336},{"@type":"BreadcrumbList","@id":"https:\/\/www.editage.com\/insights\/3-signs-of-poorly-designed-clinical-trial-protocol-includes-research-protocol-checklist-below#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.editage.com\/insights\/"},{"@type":"ListItem","position":2,"name":"3 Signs of poorly designed clinical trial protocol [Includes research protocol checklist]"}]},{"@type":"WebSite","@id":"https:\/\/www.editage.com\/insights\/#website","url":"https:\/\/www.editage.com\/insights\/","name":"Editage Insights","description":"","publisher":{"@id":"https:\/\/www.editage.com\/insights\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.editage.com\/insights\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.editage.com\/insights\/#organization","name":"Editage Insights","url":"https:\/\/www.editage.com\/insights\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.editage.com\/insights\/#\/schema\/logo\/image\/","url":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2024\/09\/editage-insights-logo-1-scaled.webp","contentUrl":"https:\/\/www.editage.com\/insights\/wp-content\/uploads\/2024\/09\/editage-insights-logo-1-scaled.webp","width":2560,"height":324,"caption":"Editage Insights"},"image":{"@id":"https:\/\/www.editage.com\/insights\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/Editage","https:\/\/x.com\/Editage"]},{"@type":"Person","@id":"https:\/\/www.editage.com\/insights\/#\/schema\/person\/c6f3704ecb3e2f11a3c19266a461a6fd","name":"Kalpataru Mukherjee","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.editage.com\/insights\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/e94c4bcd6906be8340d7661c53820bf83a816f99ad0bc082db1b3915bab1bd2b?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/e94c4bcd6906be8340d7661c53820bf83a816f99ad0bc082db1b3915bab1bd2b?s=96&d=mm&r=g","caption":"Kalpataru Mukherjee"},"url":"https:\/\/www.editage.com\/insights\/kalpataru-mukherjee"}]}},"_links":{"self":[{"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/posts\/455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/users\/618"}],"replies":[{"embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/comments?post=455"}],"version-history":[{"count":1,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/posts\/455\/revisions"}],"predecessor-version":[{"id":42834,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/posts\/455\/revisions\/42834"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/media\/33313"}],"wp:attachment":[{"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/media?parent=455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/categories?post=455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/tags?post=455"},{"taxonomy":"new_categories","embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/new_categories?post=455"},{"taxonomy":"new_tags","embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/new_tags?post=455"},{"taxonomy":"series","embeddable":true,"href":"https:\/\/www.editage.com\/insights\/wp-json\/wp\/v2\/series?post=455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}