{"id":12312,"date":"2024-07-08T09:36:59","date_gmt":"2024-07-08T09:36:59","guid":{"rendered":"https:\/\/distilinfo.com\/healthplan\/?p=12312"},"modified":"2024-07-08T09:36:59","modified_gmt":"2024-07-08T09:36:59","slug":"role-of-payers-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/distilinfo.com\/healthplan\/role-of-payers-in-clinical-trials\/","title":{"rendered":"FDA Insights on the Crucial Role of Payers in Clinical Trials"},"content":{"rendered":"\r\n<div id=\"rank-math-toc\" class=\"wp-block-rank-math-toc-block has-very-light-gray-to-cyan-bluish-gray-gradient-background has-background\"><nav>\r\n<ul>\r\n<li><a href=\"#top-5-roles-of-the-payers-in-clinical-trials-as-per-fda-guidelines\">Top 5 Roles of The Payers in Clinical Trials As Per FDA Guidelines<\/a>\r\n<ul>\r\n<li><a href=\"#1-cost-reduction\">1. Cost Reduction<\/a><\/li>\r\n<li><a href=\"#2-trackable-endpoints-and-trial-funding\">2. Trackable Endpoints and Trial Funding<\/a><\/li>\r\n<li><a href=\"#3-driving-long-term-data\">3. Driving Long-Term Data<\/a><\/li>\r\n<li><a href=\"#4-integrating-quality-measures\">4. Integrating Quality Measures<\/a><\/li>\r\n<li><a href=\"#5-bridging-real-world-applicability\">5. Bridging Real-World Applicability<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<li><a href=\"#conclusion\">Conclusion<\/a><\/li>\r\n<li><a href=\"#fa-qs\">FAQs<\/a>\r\n<ul>\r\n<li><a href=\"#1-how-do-payers-contribute-to-cost-avoidance-in-clinical-trials\">1. How do payers contribute to cost avoidance in clinical trials?\u00a0<\/a><\/li>\r\n<li><a href=\"#2-what-role-do-payers-play-in-setting-trackable-endpoints-for-clinical-trials\">2. What role do payers play in setting trackable endpoints for clinical trials?\u00a0<\/a><\/li>\r\n<li><a href=\"#3-why-is-long-term-data-important-in-clinical-trials-and-how-can-payers-help\">3. Why is long-term data important in clinical trials, and how can payers help?\u00a0<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/nav><\/div>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">A recent publication in JAMA on 1st July 2024, the <\/span><b>Pharmaceutical Research <\/b><span style=\"font-weight: 400;\">that underwent<\/span> <span style=\"font-weight: 400;\">at the FDA and Philadelphia-based University of Pennsylvania disclosed the <\/span><a href=\"https:\/\/distilinfo.com\/healthplan\/payers-in-healthcare-guide\/\"><span style=\"font-weight: 400;\">role of <\/span><b>payers in clinical trials<\/b><\/a><b>. <\/b><span style=\"font-weight: 400;\">The statement disclosed that the closer collaboration between <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> and researchers will not only ease the <\/span><b>drug development process <\/b><span style=\"font-weight: 400;\">but also boost <\/span><b>Medical Research Partnerships. <\/b><span style=\"font-weight: 400;\">Citing the statement, it was also disclosed that the collaboration will result in better <\/span><b>healthcare policy<\/b><span style=\"font-weight: 400;\"> coverage<\/span> <span style=\"font-weight: 400;\">and leverage a positive impact on <\/span><b>patient outcomes.\u00a0<\/b><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">According to the FDA reports, <\/span><b>insurance providers in research<\/b><span style=\"font-weight: 400;\"> can play a key role in <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\">. Let us look into the 5 main aspects of how <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a major role under the <\/span><b>FDA Guidelines<\/b><span style=\"font-weight: 400;\">.\u00a0\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<h2 id=\"top-5-roles-of-the-payers-in-clinical-trials-as-per-fda-guidelines\" class=\"wp-block-heading\"><b>Top 5 Roles of The Payers in Clinical Trials As Per FDA Guidelines<\/b><b><\/b><\/h2>\r\n\r\n\r\n\r\n<h3 id=\"1-cost-reduction\" class=\"wp-block-heading\">1. <b>Cost Reduction<\/b><\/h3>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">The first reason how the collaboration between <\/span><b>health insurance and clinical trials <\/b><span style=\"font-weight: 400;\">can be beneficial in <\/span><b>clinical trial funding <\/b><span style=\"font-weight: 400;\">is the reduction in costs. Primarily, it is seen that the manufacturers that undergo designing and conducting the clinical trials are often required to consider how a drug can reduce certain costs and improve healthcare services. Fortunately, this probably will not involve a slew of new endpoints but rather a different way of looking at existing endpoints.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">For example, if a manufacturer of a lipid-lowering medication is analyzing the impact on the incidence of myocardial infarction (MI), the trial readout may include how many MIs occurred in each arm of the trial and compare them for statistical significance. For the cost-savings analysis, trial investigators may recruit the services of a healthcare economist who could research the mean costs of hospitalization due to MI as well as supportive care medications.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">Considering this, the length of hospital stay and associated emergency department (ED) costs are also valuable. However, if there is a collaboration between <\/span><b>health insurance and clinical trials, <\/b><span style=\"font-weight: 400;\">the manufacturer can get the opportunity to discuss the trial data in both clinical and financial terms and this will ease the <\/span><b>drug development process<\/b><span style=\"font-weight: 400;\">.\u00a0<\/span><b><\/b><\/p>\r\n\r\n\r\n\r\n<h3 id=\"2-trackable-endpoints-and-trial-funding\" class=\"wp-block-heading\">2. <b>Trackable Endpoints and Trial Funding<\/b><\/h3>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">The second reason for how <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a major role in <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\"> is to set up certain trackable endpoints. Majorly, it is seen that the manufacturers often present the <\/span><b>patient outcomes<\/b><span style=\"font-weight: 400;\"> to the <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> that may not be trackable by them.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">For example, <\/span><b>patient outcomes<\/b><span style=\"font-weight: 400;\"> like ACR20 response in a rheumatoid arthritis trial or an improved HbA1c in a diabetes trial may be sufficient for the FDA, but such endpoints rarely show up in a health plan\u2019s data set. While the primary endpoint of a clinical trial will always need to follow <\/span><a href=\"https:\/\/www.fda.gov\/science-research\/clinical-trials-and-human-subject-protection\/regulations-good-clinical-practice-and-clinical-trials\" target=\"_blank\" rel=\"noopener\"><b>FDA Guidelines<\/b><\/a><span style=\"font-weight: 400;\">. Citing this, if there is a <\/span><b>Medical Research Partnership<\/b><span style=\"font-weight: 400;\"> between <\/span><b>health insurance and clinical trials, <\/b><span style=\"font-weight: 400;\">the <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> would be guiding the manufacturers to include secondary or exploratory endpoints that payers can review in their data.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">This, as a result, will boost <\/span><b>clinical trial funding <\/b><span style=\"font-weight: 400;\">and lead to the use of healthcare resources such as hospitalizations or visits to the ED or clinic. Enforcing this, the <\/span><b>drug development process<\/b><span style=\"font-weight: 400;\"> will get smoother and will help the patients avoid the use of certain supportive or chronic drugs. This will help the <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> to estimate the savings and strengthen the value message of the data leading to a boost in overall value.<\/span><b><\/b><\/p>\r\n\r\n\r\n\r\n<h3 id=\"3-driving-long-term-data\" class=\"wp-block-heading\">3. <b>Driving Long-Term Data<\/b><\/h3>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">The third reason for how <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a major role in <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\"> is to boost the long-term data. Primarily, the clinical trials are designed for the shortest duration to save money and get the drug to market. However, <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> hesitate to adopt new medications for the patients as the data lack long-term value.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">If there is a collaboration between <\/span><b>health insurance and clinical trials, <\/b><span style=\"font-weight: 400;\">the <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> can help the manufacturers plan long-term analyses that will enhance the pivotal clinical trials. This will lead to the development of a publication plan to communicate these long-term results. This is especially important for new cell-based and gene therapies, where <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> face high upfront. By helping the manufacturers get long-term data, the <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> can better assess the drug&#8217;s value, and boost <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\"> and cost savings over time.<\/span><b><\/b><\/p>\r\n\r\n\r\n\r\n<h3 id=\"4-integrating-quality-measures\" class=\"wp-block-heading\">4. <b>Integrating Quality Measures<\/b><\/h3>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">The fourth reason for how <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a major role in <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\"> is the boost in the quality measures by focusing on endpoints. Primarily, as the healthcare market is focusing on Value-Based Care, the significance of quality measures has increased. While not all diseases have associated quality measures, clinical trial designers should review the quality metrics relevant to the study&#8217;s disease when selecting endpoints.\u00a0<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">For instance, a drug that reduces re-hospitalization rates can improve the quality scores of a health plan or IDN, making the medication more appealing to <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\">. By aligning trial endpoints with these quality measures, payers can help to ensure the data generated is both valuable and actionable and boost <\/span><b>patient outcomes<\/b><span style=\"font-weight: 400;\">.\u00a0<\/span><b><\/b><\/p>\r\n\r\n\r\n\r\n<h3 id=\"5-bridging-real-world-applicability\" class=\"wp-block-heading\">5. <b>Bridging Real-World Applicability<\/b><\/h3>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">The fifth reason for how <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a major role in <\/span><b>clinical trial funding<\/b><span style=\"font-weight: 400;\"> is to increase real-world applicability by bridging the gap between controlled trial settings and everyday patient experiences. While clinical trials follow strict <\/span><b>FDA guidelines<\/b><span style=\"font-weight: 400;\"> and involve a selective population, the broader, real-world population often presents more variability in response, safety, and adherence. Insurance providers, being key stakeholders in the <\/span><b>drug development process<\/b><span style=\"font-weight: 400;\">, can assist in several ways.<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">Firstly, payers can work with manufacturers to ensure that the trial populations closely resemble real-world patient demographics. This can be achieved by selecting more diverse participants and considering common patterns during the trial design phase. Secondly, payers can help manufacturers develop a robust real-world evidence (RWE) strategy that continues beyond the initial trial phase. This involves collecting and analyzing data from the broader patient population once the drug is marketed, including post-market surveillance and real-world studies that provide ongoing insights into the drug\u2019s performance.<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">Lastly, <\/span><b>healthcare payers<\/b><span style=\"font-weight: 400;\"> can support the development of publication plans to communicate real-world findings to health plan customers, ensuring that the real-world experience of a drug is well-documented and available for review. This helps build confidence in the drug\u2019s efficacy and safety, aligning with <\/span><b>FDA guidelines<\/b><span style=\"font-weight: 400;\"> and the overall <\/span><b>drug development process<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\r\n\r\n\r\n\r\n<h2 id=\"conclusion\" class=\"wp-block-heading\"><b>Conclusion | Role of Payers in Clinical Trials<\/b><\/h2>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">In conclusion, <\/span><b>payers in clinical trials<\/b><span style=\"font-weight: 400;\"> can play a key role in the drug development process and clinical trial funding. Abiding by the <\/span><b>FDA guidelines<\/b><span style=\"font-weight: 400;\"> and closer collaboration between <\/span><b>health insurance and clinical trials<\/b><span style=\"font-weight: 400;\"> can significantly benefit the healthcare sector and boost <\/span><b>Medical Research Partnerships<\/b><span style=\"font-weight: 400;\"> and patient outcomes.<\/span><\/p>\r\n\r\n\r\n\r\n<p><span style=\"font-weight: 400;\">Looking for a reliable platform that can provide <\/span><b>medical updates <\/b><span style=\"font-weight: 400;\">in the <\/span><b>healthcare sector<\/b><span style=\"font-weight: 400;\">? Discover the latest <\/span><a href=\"https:\/\/distilinfo.com\/healthplan\/\"><b>payers&#8217; news updates<\/b><\/a><span style=\"font-weight: 400;\"> with a single click. Follow <a href=\"https:\/\/distilinfo.com\/healthplan\/\">DistilINFO HealthPlan<\/a> and stay ahead with the timely payer&#8217;s news updates. Join our community today!<\/span><\/p>\r\n\r\n\r\n\r\n<h2 id=\"fa-qs\" class=\"wp-block-heading\"><b>FAQs on Crucial Role of Payers in Clinical Trials<\/b><\/h2>\r\n\r\n\r\n\r\n<h3 id=\"1-how-do-payers-contribute-to-cost-avoidance-in-clinical-trials\" class=\"wp-block-heading\"><b>1. How do payers contribute to cost avoidance in clinical trials?\u00a0<\/b><\/h3>\r\n\r\n\r\n\r\n<p><b>Ans. <\/b><span style=\"font-weight: 400;\">Payers help manufacturers reduce costs by discussing trial data in both clinical and financial terms. This collaboration allows for a comprehensive analysis of cost savings related to healthcare services, such as hospitalization and supportive care, improving the efficiency of drug development<\/span><\/p>\r\n\r\n\r\n\r\n<h3 id=\"2-what-role-do-payers-play-in-setting-trackable-endpoints-for-clinical-trials\" class=\"wp-block-heading\"><b>2. What role do payers play in setting trackable endpoints for clinical trials?\u00a0<\/b><\/h3>\r\n\r\n\r\n\r\n<p><b>Ans. <\/b><span style=\"font-weight: 400;\">Payers guide manufacturers to include secondary or exploratory endpoints that are relevant to healthcare payers and can be tracked in their data. This ensures that trial outcomes are valuable for both regulatory approval and practical healthcare application, thereby enhancing clinical trial funding.<\/span><\/p>\r\n\r\n\r\n\r\n<h3 id=\"3-why-is-long-term-data-important-in-clinical-trials-and-how-can-payers-help\" class=\"wp-block-heading\"><b>3. Why is long-term data important in clinical trials, and how can payers help?\u00a0<\/b><\/h3>\r\n\r\n\r\n\r\n<p><b>Ans.<\/b><span style=\"font-weight: 400;\"> Long-term data is crucial for healthcare payers to assess the sustained value of new medications. Payers can collaborate with manufacturers to plan extended analyses and develop publication plans, providing a better understanding of the drug&#8217;s long-term benefits and improving clinical trial funding and patient outcomes.<\/span><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>A recent publication in JAMA on 1st July 2024, the Pharmaceutical Research that underwent at the FDA and Philadelphia-based University&#8230; <a href=\"https:\/\/distilinfo.com\/healthplan\/role-of-payers-in-clinical-trials\/\" style=\"white-space: nowrap;\">Continue Reading <i class=\"fas fa-long-arrow-alt-right\" style=\"vertical-align: middle;\"><\/i><\/a><\/p>\n","protected":false},"author":1,"featured_media":12313,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[1],"tags":[397],"class_list":{"0":"post-12312","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-distilinfo-originals","8":"tag-payers-in-clinical-trials","9":"entry"},"_links":{"self":[{"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/posts\/12312"}],"collection":[{"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/comments?post=12312"}],"version-history":[{"count":7,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/posts\/12312\/revisions"}],"predecessor-version":[{"id":12322,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/posts\/12312\/revisions\/12322"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/media\/12313"}],"wp:attachment":[{"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/media?parent=12312"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/categories?post=12312"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/distilinfo.com\/healthplan\/wp-json\/wp\/v2\/tags?post=12312"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}