{"id":10172,"date":"2022-08-24T11:01:35","date_gmt":"2022-08-24T11:01:35","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=10172"},"modified":"2022-09-01T11:58:10","modified_gmt":"2022-09-01T11:58:10","slug":"clinical-trials-pandemic-obstacle-evolution","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/","title":{"rendered":"Modernization of Clinical Trials Amidst the Pandemic"},"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-69f426c6e6d59\" 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-69f426c6e6d59\"><\/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\/clinical-trials-pandemic-obstacle-evolution\/#Timeline_of_clinical_trials\" title=\"Timeline of clinical trials\u00a0\">Timeline of clinical trials\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/#The_Pandemic_Obstacle\" title=\"The Pandemic Obstacle\">The Pandemic Obstacle<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/#Trials_now_Overcoming_Pandemic_Stagnation\" title=\"Trials now: Overcoming Pandemic Stagnation\">Trials now: Overcoming Pandemic Stagnation<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/#Future_that_awaits%E2%80%A6\" title=\"Future that awaits\u2026\">Future that awaits\u2026<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/#How_Regulatory_Writers_Fit_In\" title=\"How Regulatory Writers Fit In\">How Regulatory Writers Fit In<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/#Regulatory_and_technological_evolution_in_trials\" title=\"Regulatory and technological evolution in trials\">Regulatory and technological evolution in trials<\/a><\/li><\/ul><\/nav><\/div>\n<p>This article, written by Kolabtree&#8217;s freelance scientist <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/cell-aging?profile=aditi-kandlur\">Aditi Kandlur<\/a>, elaborates on how the pandemic has brought about an evolution in <a href=\"https:\/\/www.kolabtree.com\/success-story\/design-a-clinical-trial\">clinical trials<\/a>.<\/p>\n<p><span style=\"font-weight: 400;\">Globally, researchers have long since been working on various aspects of medicine. <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials\"><span style=\"font-weight: 400;\">Clinical trials<\/span><\/a><span style=\"font-weight: 400;\"> are a core part of developing medicinal and health development products. They are systematic <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> procedures\/studies carried out by <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/pioneering-medtech-healthcare-companies-in-europe\/\"><span style=\"font-weight: 400;\">pioneering companies<\/span><\/a><span style=\"font-weight: 400;\"> to evaluate medical products\/practices, mainly from a safety and security perspective. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Other clinical trials may focus on a different outcome, such as trying to gauge the efficiency of a new drug or device, garner feedback or study potential hazards and side effects. This is done prior to releasing the best drug candidates\/ medical practices into the market. These procedures have been made thorough in terms of the impact of the drug on various body systems once consumed by patients- ultimately with an aim of leading to better safety of the patients. Therefore, it is understood that the trials and other associated studies take a long time, considering challenges related to patient outcome and their availability throughout the trial.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As medical products, diagnostics and methodologies evolve, so do clinical trials, in order to ensure they stay abreast of these technological advancements. Clinical research, in fact, took quite a long time to be refined into a humane and ethical process. The evolution of clinical trials makes for a fascinating read, with the earliest recorded clinical trials taking place in 500 BC, with the procedures described mostly concerning dietary solutions. The trials have evolved into more structural and statistical notes as we progress through the centuries, lending a glimpse into how clinical trials were streamlined over the years.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Clinical trials and studies have played a significant role in the evolution of modern-day medicine. However, there were too many challenges to face with the<\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/the-definitive-list-of-covid-19-resources-for-researchers-and-businesses\/\"><span style=\"font-weight: 400;\"> COVID-19 <\/span><\/a><span style=\"font-weight: 400;\">pandemic that devastated all the sectors globally. There was immense pressure on the regulatory authorities to take urgent informed decisions considering the high-risk situation. The first lockdown across countries was when the world came to a stop; there was a great need for researchers to develop<\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/innovator-speak-kolabtree-interviews-centivax-ceo-jacob-glanville\/\"><span style=\"font-weight: 400;\"> COVID antibodies<\/span><\/a><span style=\"font-weight: 400;\">, such as therapeutics, <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/top-15-covid-19-vaccine-startups-worldwide\/\"><span style=\"font-weight: 400;\">vaccines,<\/span><\/a><span style=\"font-weight: 400;\"> or any other medical products\/devices with limited available resources. The <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7300901\/\"><span style=\"font-weight: 400;\">regulatory authorities<\/span><\/a><span style=\"font-weight: 400;\"> had to step in to build crucial systems or protocols concerning clinical trial authorization, emergency use of certain<\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/drug-development\"><span style=\"font-weight: 400;\"> drugs<\/span><\/a><span style=\"font-weight: 400;\">, and other related procedures.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Timeline_of_clinical_trials\"><\/span><b>Timeline of clinical trials\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Clinical trials have <\/span><a href=\"https:\/\/www.roche.com\/stories\/evolution-of-clinical-trials\"><span style=\"font-weight: 400;\">four phases<\/span><\/a><span style=\"font-weight: 400;\">&#8211; Phase I, where safety is tested on healthy individuals, and Phase II, where different doses are tested among a small patient population. Phase III includes tests on large sets of patients and healthy individuals followed by regulatory approval submissions and lastly, Phase IV where long-term effects of the medical product\/device.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The typical <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK286004\/#sec_85\"><span style=\"font-weight: 400;\">data life cycle of clinical trials<\/span><\/a><span style=\"font-weight: 400;\"> is based on how and what data is to be shared. This includes trial design and registration, trial participant enrollment, study completion, publication, and regulatory application.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Trial design and conceptualization generally take six months to a year; later, it can take up to a few years to enroll patients in the trial and collect their data. Even though the trial design of protocols and the statistical data analyses are planned well before the recruitment of trial participants, it undergoes changes throughout the course of the trial. These amendments are to be explicitly recorded; these come in handy during publications in medical journals and trial registrations with the World Health Organization&#8217;s (WHO&#8217;s) International Clinical Trials Registry platform.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The trial data is continuously captured individually from both patients and healthy participants. Study completion includes a declaration of the last participant interaction and additional variables that measure data points without the interactions with the participants. Bio-statistical analyses are stored along with the raw data for probable future requirements. Specific portions of the data are then segregated and used to generate results for many publications from one trial. Some parts of the data generated from the trials are also used in regulatory applications.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Suppose a medical product&#8217;s intellectual property rights (IPR) are transferred to another sponsor. In that case, there will be an <\/span><a href=\"https:\/\/www.science.org\/doi\/10.1126\/scitranslmed.3009120\"><span style=\"font-weight: 400;\">exclusive period<\/span><\/a><span style=\"font-weight: 400;\"> where the new sponsor can pursue additional studies, apply for new patents, and prepare for regulatory submissions.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As per the <\/span><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK286004\/#sec_86\"><span style=\"font-weight: 400;\">Committee on Strategies for Responsible Sharing of Clinical Trial Data<\/span><\/a><span style=\"font-weight: 400;\"> at the Institute of Medicine, Washington DC &#8211; &#8220;in case a sponsor abandons the product or indication and does not transfer the IPR to develop the product to another sponsor; sharing trial data may help other researchers and other sponsors develop similar products. Such data can benefit other researchers, clinicians, and the public, by increasing general knowledge of the product, including its efficacy and safety profile.&#8221;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">As per the <\/span><a href=\"https:\/\/journals.plos.org\/plosone\/article?id=10.1371\/journal.pone.0101826\"><span style=\"font-weight: 400;\">study conducted by Saito and Gill<\/span><\/a><span style=\"font-weight: 400;\"> in 2014, they discovered the probability of high reporting bias. This was because they found that despite the trial completion, many studies (smaller studies in earlier stages) registered in the US-based ClinicalTrials.gov database had not achieved public disclosure of results (PDOR).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This makes one question the validity of the <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-do-an-effective-literature-search-in-5-steps\/\"><span style=\"font-weight: 400;\">clinical literature<\/span><\/a><span style=\"font-weight: 400;\"> available to draw conclusions. This would complicate the situation for the upper executives in the management teams to derive data-driven decisions. Leaders must align their business goals with the available data and analyses. With the knowledge of potentially skewed data, leaders will have to consider the contextual analysis of data with the help of regulatory medical writers while applying further for regulatory applications\/certifications. In this era of data-driven leadership, data would enable foresight by understanding the deficiencies in the slow nature of trials when it comes to publishing their results, including the ones that failed to pass the tests.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Companies that hold trials or collaborate with those sponsors that carry out the trials should keep these deficiencies in mind and understand the importance of certified regulatory medical writers that would streamline the process through the regulatory approvals. Trial sponsors or pharmaceutical companies must submit detailed clinical study reports (CSRs) and individual participant data to regulatory bodies &#8211; the US Food and Administration (FDA) and the European Medicines Agency (EMA) while seeking regulatory approval for a product. Regulatory medical writers can prepare the CSRs. This process would enable better sales projections in terms of business development.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_Pandemic_Obstacle\"><\/span><b>The Pandemic Obstacle<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The COVID-19 pandemic had consequences on the global population and therefore also on clinical trials\/studies. The pandemic highlighted the loopholes in conducting trials and the need for flexibility in the system. The pandemic came with tremendous uncertainty and created incredible pressure among the researchers, regulators, and policymakers to do their best to move quickly and safely. COVID-19 has placed researchers across the globe on a strict timeline that has never been experienced before.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The clinical research field faced major concerns regarding patient safety, recruiting new trial participants, and downstream data collection and management. The dire situation of the pandemic and redirected funding helped speed up the process of developing and discovering vaccines, therapies, and diagnostics specifically for COVID-19.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Clinical research was disrupted due to the first wave of the pandemic from March to May 2020. Participant enrolments crashed to a bare minimum for many trials as hospital trips became risky. The hospital staff was redirected to focus on COVID-19 patients, clinical trials of experimental vaccines or treatment for COVID-19. Many <\/span><a href=\"https:\/\/www.nature.com\/articles\/d41586-020-00889-6\"><span style=\"font-weight: 400;\">trials were discontinued\/ suspended<\/span><\/a><span style=\"font-weight: 400;\"> as they were deemed dangerous\/highly risky during a pandemic. At the same time, the researchers tried their best to keep life-saving trials (such as cancer treatment studies) running despite the challenges. Regulatory bodies such as the USFDA issued <\/span><a href=\"https:\/\/www.nature.com\/articles\/d41586-021-01569-9\"><span style=\"font-weight: 400;\">guidance for trials<\/span><\/a><span style=\"font-weight: 400;\"> that had to pause or change course.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Similarly, EMA and other National Competent Authorities&#8217; (NCAs&#8217;) provided regulatory guidance and appropriate flexibility wherever possible to ensure trial continuity- this included digitalizing trial documents&#8217; submission and review, releasing few restrictions on the supply of investigational medicinal products. At the peak of the pandemic, various ethics committees were immersed in helping researchers alter trial plans such that they could reduce the frequency of participants visiting the clinic.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Trials_now_Overcoming_Pandemic_Stagnation\"><\/span><b>Trials now: Overcoming Pandemic Stagnation<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">As of May 15, 2020, <\/span><a href=\"https:\/\/www.biopharmadive.com\/news\/coronavirus-clinical-trial-disruption-biotech-pharma\/574609\/\"><span style=\"font-weight: 400;\">BioPharmaDive<\/span><\/a><span style=\"font-weight: 400;\"> reported that nearly 100 companies and 240 trials had experienced disruptions. Major sponsors involved in the clinical trials, such as CROs and pharma companies, faced difficulties in patient recruitment and retention, safety, distribution\/ supply of drugs, and scarcity of research staff at particular sites, which brought financial loss. The stagnation brought about delays in trial data submitted to the regulatory bodies, leading to delays in drug launches and in understanding which drug trials were to be dropped.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">After the stagnation that disrupted clinical research globally, sharing and collaborating have become the <\/span><a href=\"https:\/\/www.thelancet.com\/journals\/langlo\/article\/PIIS2214-109X%2820%2930542-8\/fulltext\"><span style=\"font-weight: 400;\">main themes of operation during clinical trials<\/span><\/a><span style=\"font-weight: 400;\">\/studies. Researchers have begun utilizing data-sharing cross-functional platforms such as <\/span><a href=\"https:\/\/www.hdruk.ac.uk\"><span style=\"font-weight: 400;\">Health Data Research UK<\/span><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/vivli.org\"><span style=\"font-weight: 400;\">Vivli<\/span><\/a><span style=\"font-weight: 400;\">. The data in these platforms can be reviewed, analyzed and curated securely.<\/span><\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8013428\/\"><span style=\"font-weight: 400;\">EMA and other NCAs<\/span><\/a><span style=\"font-weight: 400;\"> improved the flexibility in how the trials operated by adopting measures such as centralized monitoring, telemedicine visits, and remote source data verification (rSDV) for various trials as per the <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic\"><span style=\"font-weight: 400;\">EMA guidance<\/span><\/a><span style=\"font-weight: 400;\"> on CT management during the pandemic (version 4; February 4, 2021). The guidelines also permit rSDV in regions outside the EU\/EEA with the data protection rules applicable per EU norms.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The pandemic proved a great need for<\/span><a href=\"https:\/\/www.nature.com\/articles\/d41586-021-01255-w\"><span style=\"font-weight: 400;\"> improving coordination and collaboration<\/span><\/a><span style=\"font-weight: 400;\"> among the various stakeholders in clinical research. This could be achieved by funding bodies and global research organizations that hold the most amount of control over the trial designs. The UK RECOVERY trial and WHO SOLIDARITY trial are the two trials that showed great coordination among hospitals. They even took up an approach that involved multiple treatments against one condition while coordinating between multiple hospitals; this gave the trials sufficient numbers of patients to participate in the trials. This model that arose to tackle the problems of the pandemic, if widely applied to the ongoing or the upcoming trials, could pose a boon to provide a necessary number of participants and help prevent delays or slowing down of trials.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">This collaborative approach would involve doctors and researchers to help them understand and experience running a well-designed trial.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Future_that_awaits%E2%80%A6\"><\/span><b>Future that awaits\u2026<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The pandemic drove the operation of clinical trials as a catalyst in alternative and innovative approaches that were not implemented pre-COVID times. These include remote monitoring, phone and video visits, eConsent and electronic health records. As per the survey conducted by Informa Pharma Intelligence and <\/span><a href=\"https:\/\/www.oracle.com\/in\/industries\/life-sciences\/clinical-research\/clinical-trials-post-covid-research\/\"><span style=\"font-weight: 400;\">Oracle<\/span><\/a><span style=\"font-weight: 400;\">, &#8220;82% of respondents feel that the new approaches adopted during the pandemic have had a positive impact on clinical trials overall, including 26% reporting a significantly positive impact.&#8221;<\/span><\/p>\n<p><span style=\"font-weight: 400;\">These <\/span><a href=\"https:\/\/www.nature.com\/articles\/s41569-020-00439-7\"><span style=\"font-weight: 400;\">newly adopted methods<\/span><\/a><span style=\"font-weight: 400;\"> could seem like temporary stop-gap measures but are influencing the <\/span><a href=\"https:\/\/www.hcltech.com\/blogs\/changing-dynamic-clinical-trials-post-pandemic-world\"><span style=\"font-weight: 400;\">evolution of clinical trials<\/span><\/a><span style=\"font-weight: 400;\"> in a post-pandemic world. A few of them include,<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>The transition to decentralized trials<\/b><span style=\"font-weight: 400;\">: Historically, most clinical trials were conducted in a centralized\/localized manner- an urban location or large institute. The pandemic gave the push to widen the net to recruit more patients and possibly do trials in a faster way as there are lesser chances of delay due to the lesser number of available patients. This occurred while balancing the rising concerns regarding data quality and regulatory compliance. Major pharmaceutical players such as Pfizer-BioNTech, Johnson &amp; Johnson, and Moderna successfully ran several trials for the COVID-19 vaccines, mainly decentralized. This has led to vaccine development, tests and release in record time despite limited resources with the coordination and efforts of the researchers, government, and community. These instances have shown the world that trials can be conducted faster, safer, and cheaper, breaking all barriers of bureaucracy to the betterment of humanity- a sure sign that virtual clinical trials are here to stay.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Communication and coordination among various stakeholders<\/b><span style=\"font-weight: 400;\">: Research sites learned the importance of effective communication and coordination. Due to a staff shortage at sites, loads of those sites were shifted to another site. This load shifting was only possible through the investigator maintaining clear communication between the sites and sponsors. During such volatile situations where the regulations kept altering, the investigator and regulatory medical writers had to prevent confusion in deciphering it. This need to improve communication has encouraged better investment in communication technology and skills to bring about intra-site coordination to expedite future clinical trials through agility in working and quick problem-solving.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Increasing virtual trials through mergers and acquisitions<\/b><span style=\"font-weight: 400;\">: <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency\"><span style=\"font-weight: 400;\">FDA<\/span><\/a><span style=\"font-weight: 400;\"> and other regulatory bodies across the globe have begun promoting the adoption of virtual clinical trials, providing flexibility to the investigators in framing appropriate protocols that would support remote care. The pandemic has also influenced an increase in partnerships and M&amp;As. This change is occurring with the primary objective of providing support for the virtual trials in the new post-pandemic world. ERT, a clinical trial data management company, merged with Bioclinica to become a clinical trial endpoint technology leader. The virtual setup of trials has also promoted trial training to be conducted virtually and remotely.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Improved patient\/participant recruitment<\/b><span style=\"font-weight: 400;\">: Trial participant recruitment has become more distributed and decentralized across various regions and geographies to mitigate scarcity. This widespread participation has been enabled through methods that will soon become an industry norm, such as electronic consent (following the Good Clinical Practice (GCP) governed by ICH regulatory guidelines), virtual consultation, and remote monitoring. This pandemic led to increased consumer devices (phones- class II devices) to be used for test data collection securely and safely. With data as a universal equalizer, the post-pandemic era sees the ability to securely and safely collect upstream data from trial participants becoming a big highlight.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Decrease in cost<\/b><span style=\"font-weight: 400;\">: The decentralized trials would cause a reduction in the costs involved in various aspects of running a trial. This cost reduction would be brought about by virtual meetings, remote clinical staff, and remote monitoring.<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"How_Regulatory_Writers_Fit_In\"><\/span><b>How<\/b><b> Regulatory Writers<\/b><b> Fit In<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Taking up the prep work of detailed research and regulatory documents is usually an arduous task. Summarizing the complete procedure, methodologies and results of a drawn-out clinical trial in an objective manner requires a specific level of expertise that only <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-compliance\"><span style=\"font-weight: 400;\">qualified regulatory writers<\/span><\/a><span style=\"font-weight: 400;\"> can provide.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the aftermath of the pandemic, with the increasing adoption of virtual trials, the transition of academics to<\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/kolabtree-mixer-interview-with-the-platforms-top-freelance-consultants\/\"><span style=\"font-weight: 400;\"> full-time freelancing<\/span><\/a><span style=\"font-weight: 400;\"> and the growing integration of<\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/hybrid-team-manage-freelancers-remote-working\/\"><span style=\"font-weight: 400;\"> hybrid workforces<\/span><\/a><span style=\"font-weight: 400;\">, freelance regulatory writers can prove a cost-effective option for organizations.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Kolabtree\u2019s <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?page-index=4\"><span style=\"font-weight: 400;\">independent regulatory writers<\/span><\/a><span style=\"font-weight: 400;\">, for example, work on <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/gig-economy-trends-2021-the-birth-of-an-expert-economy\/\"><span style=\"font-weight: 400;\">flexible <\/span><\/a><span style=\"font-weight: 400;\">on-demand projects helping organizations create and curate effective submission documents that ensure adherence to <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/how-biotech-firms-can-ensure-regulatory-compliance-an-expert-guide\/\"><span style=\"font-weight: 400;\">guidelines<\/span><\/a><span style=\"font-weight: 400;\"> outlined by the relevant regulatory authorities.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A good regulatory writer not only guarantees compliance with existing rules but also designs protocols to maintain adherence going forward by eliminating potential scenarios that may lead to non-compliance in the future. Right from understanding the industry framework, to analyzing complex statistical data, a qualified regulatory writer does it all.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">More significantly,<\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\"><span style=\"font-weight: 400;\"> freelance writers<\/span><\/a><span style=\"font-weight: 400;\"> prove to be a good value for both money and time, as they can be consulted without the additional hassle of onboarding costs and procedures. Platforms like <\/span><a href=\"https:\/\/www.kolabtree.com\/\"><span style=\"font-weight: 400;\">Kolabtree<\/span><\/a><span style=\"font-weight: 400;\"> aim to make this process more efficient and streamlined by offering the clients several benefits, such as a secure workspace that ensures complete <\/span><a href=\"https:\/\/www.kolabtree.com\/blog\/3-ways-kolabtree-guarantees-data-security-whilst-hiring-freelancers\/\"><span style=\"font-weight: 400;\">data confidentiality<\/span><\/a><span style=\"font-weight: 400;\">, custom NDA options to sign with the freelance consultant, and a global network of independent regulatory writers to vet and hire from.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Regulatory_and_technological_evolution_in_trials\"><\/span><b>Regulatory and technological evolution in trials<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The<\/span><a href=\"https:\/\/www.oracle.com\/in\/industries\/life-sciences\/clinical-research\/clinical-trials-post-covid-research\/\"><span style=\"font-weight: 400;\"> Oracle and Informa Pharma Intelligence survey<\/span><\/a><span style=\"font-weight: 400;\"> also found that researchers using new methods in the trials found data more time efficient, higher quality and robust. About 81% of researchers using these modified approaches have high confidence in the data obtained. Here, 92% of the survey participating researchers stated that the new methods during the pandemic resulted in equal or more confidence in the data compared to the data collected employing pre-pandemic approaches. The survey also showed support for using hybrid (44%) and fit-for-purpose (42%) models after the pandemic. About 61% of researchers also believe a positive impact could be brought by allowing the patients freedom to choose the manner in which they would like to participate in the trials.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The survey results strongly suggest that the new methods are here to stay and give scope for more evolution of the methods in clinical trials.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Regulatory recommendations from <\/span><a href=\"https:\/\/www.oecd.org\/coronavirus\/policy-responses\/greater-harmonisation-of-clinical-trial-regulations-would-help-the-fight-against-covid-19-732e1c5c\/\"><span style=\"font-weight: 400;\">OECD<\/span><\/a><span style=\"font-weight: 400;\"> (The Organisation for Economic Co-operation and Development) suggest improving consistency through a standardized risk-based approach across national regulations and their interpretations while also protecting the participants of the trials. OECD also encourages international harmonization of multiple aspects of clinical trial regulations that can be achieved by working with the International Council for Harmonization (ICH) and public health professionals who are members of the Clinical Research Initiative for Global Health (CRIGH).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Fortunately, technological advancements in clinical research are evolving to help bridge such collaborations and carry the industry into the future.<\/span><\/p>\n<p><i><span style=\"font-weight: 400;\">\u00a0<\/span><\/i><b>References<\/b><\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7300901\/\"><span style=\"font-weight: 400;\">Pandemic Best Regulatory Practices: An Urgent Need in the COVID\u201019 Pandemic\u200a\u2014\u200aPMC (nih.gov)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.roche.com\/stories\/evolution-of-clinical-trials\"><span style=\"font-weight: 400;\">https:\/\/www.roche.com\/stories\/evolution-of-clinical-trials<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK286004\/#sec_85\"><span style=\"font-weight: 400;\">THE CLINICAL TRIAL LIFE CYCLE- Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk- NCBI Bookshelf (nih.gov)<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Rai AK, Rice G. Use patents can be useful: the case of rescued drugs. Sci Transl Med. 2014;6(248):248fs30. Doi:<\/span> <span style=\"font-weight: 400;\">https:\/\/doi.org\/10.1126\/scitranslmed.3009120<\/span><\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/books\/NBK286004\/#sec_86\"><span style=\"font-weight: 400;\">WHAT DATA SHOULD BE SHARED- Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk\u200a\u2014\u200aNCBI Bookshelf (nih.gov)<\/span><\/a><\/p>\n<p><span style=\"font-weight: 400;\">Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain?\u200a\u2014\u200aA statistical analysis of the ClinicalTrials.gov database. <\/span><i><span style=\"font-weight: 400;\">PLoS One<\/span><\/i><span style=\"font-weight: 400;\">. 2014;9(7):e101826. Published 2014 Jul 15. Doi:<\/span><a href=\"https:\/\/doi.org\/10.1371\/journal.pone.0101826\"> <span style=\"font-weight: 400;\">https:\/\/doi.org\/10.1371\/journal.pone.0101826<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.thelancet.com\/journals\/langlo\/article\/PIIS2214-109X%2820%2930542-8\/fulltext\"><span style=\"font-weight: 400;\">How COVID-19 has fundamentally changed clinical research in global health\u200a\u2014\u200aThe Lancet Global Health<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.nature.com\/articles\/d41586-021-01569-9\"><span style=\"font-weight: 400;\">The COVID pandemic\u2019s lingering impact on clinical trials (nature.com)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.nature.com\/articles\/d41586-020-00889-6\"><span style=\"font-weight: 400;\">Coronavirus shuts down trials of drugs for multiple other diseases (nature.com)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency\"><span style=\"font-weight: 400;\">FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency | FDA<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.hcltech.com\/blogs\/changing-dynamic-clinical-trials-post-pandemic-world\"><span style=\"font-weight: 400;\">Changing Dynamics of Clinical Trials in the Post Pandemic World | HCL Blogs (hcltech.com)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8013428\/\"><span style=\"font-weight: 400;\">COVID\u201019 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union\u200a\u2014\u200aPMC (nih.gov)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.biopharmadive.com\/news\/coronavirus-clinical-trial-disruption-biotech-pharma\/574609\/\"><span style=\"font-weight: 400;\">https:\/\/www.biopharmadive.com\/news\/coronavirus-clinical-trial-disruption-biotech-pharma\/574609\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.oracle.com\/in\/industries\/life-sciences\/clinical-research\/clinical-trials-post-covid-research\/\"><span style=\"font-weight: 400;\">https:\/\/www.oracle.com\/in\/industries\/life-sciences\/clinical-research\/clinical-trials-post-covid-research\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.nature.com\/articles\/s41569-020-00439-7\"><span style=\"font-weight: 400;\">The COVID-19 pandemic: a catalyst to improve clinical trials | Nature Reviews Cardiology<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.nature.com\/articles\/d41586-021-01255-w\"><span style=\"font-weight: 400;\">Evidence-based medicine: how COVID can drive positive change (nature.com)<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.oecd.org\/coronavirus\/policy-responses\/greater-harmonisation-of-clinical-trial-regulations-would-help-the-fight-against-covid-19-732e1c5c\/\"><span style=\"font-weight: 400;\">Greater harmonisation of clinical trial regulations would help the fight against COVID-19 (oecd.org)<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>This article, written by Kolabtree&#8217;s freelance scientist Aditi Kandlur, elaborates on how the pandemic has brought about an evolution in clinical trials. Globally, researchers have long since been working on various aspects of medicine. Clinical trials are a core part of developing medicinal and health development products. They are systematic research procedures\/studies carried out by<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/clinical-trials-pandemic-obstacle-evolution\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":605,"featured_media":10176,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,558,654,247,540],"tags":[253,467,554,553],"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>Modernization of Clinical Trials Amidst the Pandemic -<\/title>\n<meta name=\"description\" content=\"This article elaborates on how the pandemic has brought upon an evolution in clinical trials, and how companies conduct them.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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