{"id":7884,"date":"2022-09-15T10:00:00","date_gmt":"2022-09-15T10:00:00","guid":{"rendered":"https:\/\/www.rednovius.com\/?p=7884"},"modified":"2022-12-07T12:36:13","modified_gmt":"2022-12-07T12:36:13","slug":"decentralized-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.rednovius.com\/decentralized-clinical-trials\/","title":{"rendered":"Decentralized clinical trials: What are the challenges to come?"},"content":{"rendered":"\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.rednovius.com\/book-expert-session\/\" target=\"_blank\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?resize=1024%2C683&#038;ssl=1\" alt=\"Decentralized clinical trials: what are the challenges to come?\" class=\"wp-image-7902\" srcset=\"https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?resize=1024%2C683&amp;ssl=1 1024w, https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?resize=300%2C200&amp;ssl=1 300w, https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?resize=768%2C512&amp;ssl=1 768w, https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?resize=900%2C600&amp;ssl=1 900w, https:\/\/i0.wp.com\/www.rednovius.com\/wp-content\/uploads\/2022\/07\/Decentralized-clinical-trials-what-are-the-challenges-to-come-1.png?w=1200&amp;ssl=1 1200w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" data-recalc-dims=\"1\" \/><\/a><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Clinical trials were re-thought thanks to the pandemic. Decentralized clinical trials (DCTs), at first seemed like a temporary solution. Yet, as time went on, pharma began to pick up on some of its main advantages, especially flexibility. Can clinical trials be permanently shaped by a <strong><a href=\"https:\/\/www.rednovius.com\/pharma-communication-new-normal-urgency\/\" target=\"_blank\" rel=\"noreferrer noopener\">hybrid or a remote model<\/a><\/strong>?<\/p>\n\n\n\n<p>The truth is that decentralized clinical trials were not a new model in these procedures. Pfizer launched a virtual trial back in 2011. At first, this didn\u2019t catch on as much with pharma in general. Between the second half of 2019 and 2020, ZS\u2019s DCT database <strong><a href=\"https:\/\/www.rednovius.com\/more-data-less-time-3-new-ways-to-approach-hcp\/\" target=\"_blank\" rel=\"noreferrer noopener\">reported data<\/a><\/strong> from more than 1,000 trials.<\/p>\n\n\n\n<p>This means that this new model for clinical trials has caught on. And it&#8217;s here to <strong><a href=\"https:\/\/www.rednovius.com\/pharma-marketing-3-patient-motivated-changes\/\" target=\"_blank\" rel=\"noreferrer noopener\">shape these procedures permanently<\/a><\/strong>. More than one benefit comes from this new model of trials which we will be exploring further in this text.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"has-text-align-center wp-block-heading\" style=\"font-size:46px\"><strong>Why are Decentralized Clinical Trials here to stay?<\/strong><\/h2>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Thanks to COVID-19, there was a <strong><a href=\"https:\/\/www.rednovius.com\/2022-best-marketing-strategy-looking-back-to-move-forward\/\" target=\"_blank\" rel=\"noreferrer noopener\">permanent shaping<\/a><\/strong> of the balance of tradeoffs in pharma. New challenges rose with this decentralization. Yet the benefits of DCTs have shown to be worth the investment.&nbsp;<\/p>\n\n\n\n<p>Applied Clinical Trials have highlighted four main points that show that these clinical trials will have their place in <strong><a href=\"https:\/\/www.rednovius.com\/a-new-not-normal-after-covid-what-does-it-mean-for-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">post-pandemic reality<\/a><\/strong>. In the next topic, we&#8217;ll introduce some of them.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"has-text-align-center wp-block-heading\" style=\"font-size:44px\"><strong>The advantages of DCTs in a post-pandemic reality<\/strong><\/h4>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul><li><strong><a href=\"https:\/\/www.rednovius.com\/a-new-not-normal-after-covid-what-does-it-mean-for-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">Technological maturity<\/a>: <\/strong>The evolution of technology is one of the main factors that influence the rest of the topics mentioned. Investments in this sense are also contributing to a decentralized model. We can expect more end-to-end technological solutions fit for DCTs.<\/li><li><strong><span style=\"text-decoration: underline;\">Increased investment in DCTs:<\/span> <\/strong>Pharma companies are creating new possibilities for DCT models. There are <strong><a href=\"https:\/\/www.rednovius.com\/2022-best-marketing-strategy-looking-back-to-move-forward\/\" target=\"_blank\" rel=\"noreferrer noopener\">technological options<\/a><\/strong> that can operate several procedures at scale. Not only that but as well as new group possibilities with dedicated leadership.<\/li><li><strong><a href=\"https:\/\/www.rednovius.com\/patients-top-chosen-channels-for-information-gathering\/\" target=\"_blank\" rel=\"noreferrer noopener\">Digital patient experience:<\/a> <\/strong>In the midst of all this, we can\u2019t forget the increasing experience that patients also have with the digital spectrum. Elements such as digital pharmacies or telemedicine helped to enhance the expectations of their clinical trial experience.<\/li><li><strong><span style=\"text-decoration: underline;\">Easier regulatory direction<\/span>:<\/strong> Thanks to COVID-19, several regulatory agencies, including the FDA, made an effort to clarify their guidance on <strong><a href=\"https:\/\/www.rednovius.com\/knowledge-translation-hcp-education\/\" target=\"_blank\" rel=\"noreferrer noopener\">decentralized practices<\/a><\/strong>. It\u2019s predicted that in the case of DCTs, the FDA will use its new Digital Health Center of Excellence to help these procedures take place in an easier regulatory landscape.<\/li><\/ul>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"has-text-align-center wp-block-heading\" style=\"font-size:46px\"><strong>What are the pros and cons of Decentralized Clinical Trials?<\/strong><\/h3>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The main advantage related to decentralized clinical trials has to do with the <strong><a href=\"https:\/\/www.rednovius.com\/customer-centric-approach-in-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">patient-centric approach<\/a><\/strong>. One that helps to address a variety of their needs.&nbsp;<\/p>\n\n\n\n<p>All in all, this new model creates a more <strong><a href=\"https:\/\/www.rednovius.com\/2022-top-guidelines-for-hcp-engagement\/\" target=\"_blank\" rel=\"noreferrer noopener\">streamlined experience<\/a><\/strong>. It applies to both the organizers and the participants in the trials.<\/p>\n\n\n\n<p>Among them, we can highlight the fact that they can help reduce the time factor that defines in-person visits. There\u2019s also the fact that DCTs enable <strong><a href=\"https:\/\/www.rednovius.com\/pharma-marketing-3-patient-motivated-changes\/\" target=\"_blank\" rel=\"noreferrer noopener\">wider patient access<\/a><\/strong>. Especially for people living in either rural or underrepresented communities.&nbsp;<\/p>\n\n\n\n<p>In short, there are a lot of advantages that open up a conversation for comparison of DCTs with traditional trials. Decentralized clinical trials also ease the clinical development process. Thereby helping to generate <strong><a href=\"https:\/\/www.rednovius.com\/more-data-less-time-3-new-ways-to-approach-hcp\/\" target=\"_blank\" rel=\"noreferrer noopener\">more conclusive evidence<\/a><\/strong>.&nbsp;<\/p>\n\n\n\n<p>The fact that it\u2019s a decentralized process also helps the sponsors. Not only can it increase compliance, but it can also reduce drop-out rates. The fact that this new model can help <strong><a href=\"https:\/\/www.rednovius.com\/more-data-less-time-3-new-ways-to-approach-hcp\/\" target=\"_blank\" rel=\"noreferrer noopener\">collect more advanced data<\/a><\/strong>, generates a great help for evidence packages and shows the create value of these trials for patients.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"has-text-align-center wp-block-heading\" style=\"font-size:44px\"><strong>The challenges of DCTs<\/strong><\/h4>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Yet, a decentralized process means <strong><a href=\"https:\/\/www.rednovius.com\/how-to-succeed-going-omnichannel-in-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">more complexity<\/a><\/strong>. One of the main challenges has to do with the increasing need for resources. We mean those that can help DCTs to take place with success. This also poses many challenges for sponsors in particular.<\/p>\n\n\n\n<p>The sponsors will have many roles to play in this context. They must learn how to implement DCTs, as well as figure out what they need to do to <strong><a href=\"https:\/\/www.rednovius.com\/patients-top-chosen-channels-for-information-gathering\/\" target=\"_blank\" rel=\"noreferrer noopener\">support patients on their journeys<\/a><\/strong>. At the same time, they need to capture the real value of DCTs, while comparing them to traditional clinical trials.<\/p>\n\n\n\n<p>It involves more work to properly understand the <strong><a href=\"https:\/\/www.rednovius.com\/pharma-marketing-3-patient-motivated-changes\/\" target=\"_blank\" rel=\"noreferrer noopener\">impact that this new model can have on patients<\/a><\/strong>. When it comes to regulations, DCTs are still developing and lack consistent standards. In the initial phase, sponsors will have to concentrate on priority markets.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"has-text-align-center wp-block-heading\" style=\"font-size:46px\"><strong>How can Decentralized Clinical Trials be implemented successfully?<\/strong><\/h3>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>For this decentralized model to work, it has to be properly implemented. This means that the traditional way won\u2019t always work as a blueprint to <strong><a href=\"https:\/\/www.rednovius.com\/a-new-not-normal-after-covid-what-does-it-mean-for-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">create a new model<\/a><\/strong>. Pharma companies in this sense will need to take a more comprehensive approach.<\/p>\n\n\n\n<p>There needs to be a focus on one core goal for the whole process to be perfectly reliable. Pharmaceutical companies need to reflect on how they can answer a certain question <strong><a href=\"https:\/\/www.rednovius.com\/2022-best-marketing-strategy-looking-back-to-move-forward\/\" target=\"_blank\" rel=\"noreferrer noopener\">from a digital perspective.<\/a><\/strong> Consulting with DCP support providers must happen to discover the best method to achieve the trial\u2019s goals.<\/p>\n\n\n\n<p>One must always remember that some therapy areas fit better than others in a decentralized clinical trial. Right now, areas such as cardiovascular, diabetes, and neurology are the most common areas for this approach. In the future, this might be adaptable to other areas. But for certain therapies, this may never be applicable.<\/p>\n\n\n\n<p>It\u2019s important to keep in mind that, as these procedures become more common, <strong><a href=\"https:\/\/www.rednovius.com\/pharma-marketing-3-patient-motivated-changes\/\" target=\"_blank\" rel=\"noreferrer noopener\">patient experience<\/a><\/strong> and <strong><a href=\"https:\/\/www.rednovius.com\/more-data-less-time-3-new-ways-to-approach-hcp\/\" target=\"_blank\" rel=\"noreferrer noopener\">data collection<\/a><\/strong> will have a bar raised. DCTs will evolve in unimaginable ways in the following years, changing the performances of many current clinical trials.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"has-text-align-center wp-block-heading\" style=\"font-size:44px\"><strong>Conclusions<\/strong><\/h4>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>One thing is for certain: pharma companies are not trailing this road alone. Many investigators, patients, regulators, and sites are also willing to embrace this change in this procedure. This will be one of the main elements which will contribute to the <strong><a href=\"https:\/\/www.rednovius.com\/customer-centric-approach-in-pharma\/\" target=\"_blank\" rel=\"noreferrer noopener\">customer-centric approach<\/a><\/strong> that healthcare will be walking toward in the future.<\/p>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-align-center\"><strong>Want to introduce the full method of a clinical trial to healthcare professionals? <a href=\"https:\/\/www.rednovius.com\/book-expert-session\/\" target=\"_blank\" rel=\"noreferrer noopener\">All you need is a PubVisual to make it simple.<\/a><\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><strong>In <a href=\"https:\/\/www.linkedin.com\/company\/rednovius\/\" target=\"_blank\" rel=\"noreferrer noopener\">90 seconds or less<\/a>, your medical content can be simple. In fact, it can be snackable and fit to show to physicians, medical teams, doctors, and more.<\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><strong><a href=\"https:\/\/www.rednovius.com\/book-expert-session\/\" target=\"_blank\" rel=\"noreferrer noopener\">Book your meeting and you can see a demo of what we can do for you.<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical trials were re-thought thanks to the pandemic. Decentralized clinical trials (DCTs), at first seemed like a temporary solution.<\/p>\n","protected":false},"author":2,"featured_media":7902,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"footnotes":""},"categories":[57,51,56],"tags":[361,362,22,359,360,358,363,364,366,365],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Decentralized clinical trials: what are the challenges to come?<\/title>\n<meta name=\"description\" content=\"Decentralized clinical trials (DCTs) are turning into a trend. 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