[{"data":1,"prerenderedAt":320},["ShallowReactive",2],{"slug-in-silico-trials-are-the-future":3},{"post":4,"relatedPosts":196,"relatedBooks":319},{"id":5,"date":6,"date_gmt":7,"guid":8,"modified":10,"modified_gmt":11,"slug":12,"status":13,"type":14,"link":15,"title":16,"content":18,"excerpt":21,"author":23,"featured_media":24,"comment_status":25,"ping_status":25,"sticky":26,"template":27,"format":28,"meta":29,"categories":30,"tags":34,"project_category":53,"contact_email_category":54,"yst_prominent_words":55,"class_list":65,"better_featured_image":93,"acf":131,"yoast_meta":140,"_links":143},24540,"2019-08-10T11:00:05","2019-08-10T09:00:05",{"rendered":9},"https:\u002F\u002Fmedicalfuturist.com\u002F?post_id=24540&_wpnonce=7c9c1f49a6&status=auto-draft&type=post","2023-03-21T08:11:38","2023-03-21T07:11:38","in-silico-trials-are-the-future","publish","post","https:\u002F\u002Fmedicalfuturist.com\u002Fin-silico-trials-are-the-future",{"rendered":17},"Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future",{"rendered":19,"protected":20},"\n\u003Ctable style=\"width: 100%; border-collapse: collapse; background-color: #eee; border-top: 4px solid #444;\" cellpadding=\"5px\">\n\u003Ctbody>\n\u003Ctr>\n\u003Ctd style=\"width: 100%;\">\n\u003Cp style=\"color: #555;font-size: 12px;line-height: 14px\">THIS ARTICLE HAS NOT BEEN UPDATED SINCE 2019. THE INFORMATION SHARED IN THE ARTICLE WAS ACCURATE AT THE TIME OF ITS PUBLICATION, BUT IT MAY BE OUT OF DATE NOW. \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fmagazine\">BROWSE OUR LATEST ARTICLES HERE\u003C\u002Fa>\u003C\u002Fp>\n\u003C\u002Ftd> \u003C\u002Ftr>\u003C\u002Ftbody>\u003C\u002Ftable>\n\n\n\n\u003Cp>Traditional clinical trials are equivalent to billions of dollars and years of hard work with no guarantee for the new drug to be approved by regulatory bodies, not to speak about the dangers of testing medication on animals and\u002For humans. What if we could take a radical turn? What if we conducted clinical trials on virtual bodies that could perfectly mimic human physiology? With the help of artificial intelligence, enhanced computer simulations, and advances in personalized medicine, in silico trials might be a reality in the coming years.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>The magic expression is in\nsilico\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>As technologies transform every aspect of healthcare,\nmedicine, and the pharma industry, the monstrous clinical trial enterprise\ncannot be left out either. One way to \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Ffuture-of-clinical-trials\">modernize the drug testing process\u003C\u002Fa> is applying technologies to the traditional framework,\nfor example through \u003Ca href=\"http:\u002F\u002Ftrialreach.com\u002F\">online platforms\u003C\u002Fa> to seek out participants; while an alternative way is\nto build a completely new setting. \u003Ca href=\"https:\u002F\u002Fwyss.harvard.edu\u002Ftechnology\u002Fhuman-organs-on-chips\u002F\">Human organs-on-chips\u003C\u002Fa> and in silico trials represent the second approach. Researchers\nof the Wyss Institute have been working on the first strand, human\norgans-on-chips for years. These microdevices lined by living human cells can\nmimic the microarchitecture and functions of human organs, and this makes them\nideal for replacing clinical testing. \u003C\u002Fp>\n\n\n\n\u003Cp>Going one Neil Armstrong-step further, we arrive at in\nsilico trials: no humans, no animals, not even a single cell is required, and\nyet the impact of any given therapy, treatment option, or drug can be perfectly\ncharted. In silico is \u003Ca href=\"https:\u002F\u002Fcordis.europa.eu\u002Fresult\u002Frcn\u002F86061_en.html\">the term scientists use to describe the modeling, simulation,\nand visualization of biological and medical processes in computers\u003C\u002Fa>. The emergence of in silico medicine is a result of\nthe advance of medical computer science over the last 20 years. \u003C\u002Fp>\n\n\n\n\u003Cp>Modeling maps the elements of a biological system, simulation attempts to realistically show how that system evolves over time under given stimuli, and visualization presents the predictions in a graphic form. \u003Cstrong>When looking at an in silico clinical trial specifically, it means an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. While completely simulated clinical trials are not feasible with current technology and understanding of biology, their development would be expected to have major benefits over current in vivo clinical trials, and \u003Ca href=\"https:\u002F\u002Fwww.theatlantic.com\u002Fsponsored\u002Fvmware-2017\u002Fvirtual-body\u002F1625\u002F\">the FDA is already planning for a future\u003C\u002Fa> in which more than half of all clinical trial data will come from computer simulations. \u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"512\" height=\"288\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-512x288.png\" alt=\"in silico trials\" class=\"wp-image-24541\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-512x288.png 512w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-370x208.png 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-768x432.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials.png 800w\" sizes=\"auto, (max-width: 512px) 100vw, 512px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">Source: https:\u002F\u002Fwww.change.org\u002Fp\u002Fguido-rasi-foster-adoption-of-in-silico-trials-through-ema-s-strategy-on-regulatory-science-to-2025\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>All\ngain, no pain\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>The main advantage of in silico trials resides in the context of simulations: the effects of new drugs or treatment options are played out in a virtual setting without real consequences for either animals or humans. They also enhance personalized medicine: these processes allow doctors to try out treatment plans, to get to know the behavior of drugs or to identify the most appropriate drug dosage. \u003C\u002Fp>\n\n\n\n\u003Cp>With the advancement of cognitive computing and\nbioinformatics, it becomes possible to simulate real biological processes in\nvirtual settings through the use of big data. The computational environment\nenables researchers to build circulatory, neural, endocrine, metabolic systems\n– or anything else using these enormous volumes of data sets. As a final\nobjective, \u003Cstrong>these individual layers of\nthe human physiology could be combined to capacitate the examination of the\nhuman body as a whole. The ultimate results are faster and more flexible\nclinical trials and a significant reduction in costs\u003C\u002Fstrong>.\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Cstrong>Moreover,\u003C\u002Fstrong> \u003Cstrong>artificial intelligence can also provide answers to the usually asked question: “why does this work for this patient but not another one?”\u003C\u002Fstrong> A.I-building methods, namely \u003Ca href=\"https:\u002F\u002Fwww.forbes.com\u002Fsites\u002Fyiannismouratidis\u002F2018\u002F11\u002F14\u002Fbillions-will-be-poured-into-ai-drug-development\u002F#700763f57b9f\">machine learning and deep learning have the potential to train a model\u003C\u002Fa> that will then be able to find patterns and clusters in otherwise unstructured data – and seek out information researchers didn’t expect to be there. In addition, neural networks can be used to predict adverse events or to anticipate the possible risk of patient drop out and compliance to the treatment.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"2121\" height=\"1414\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations.jpg\" alt=\"in silico trials\" class=\"wp-image-24542\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations.jpg 2121w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations-768x512.jpg 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations-1536x1024.jpg 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations-2048x1365.jpg 2048w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FIn-Silico-Trials-And-Simulations-512x341.jpg 512w\" sizes=\"auto, (max-width: 2121px) 100vw, 2121px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">Source: www.knect365.com\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>Virtual humans everywhere\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>\u003Cstrong>While in silico medicine is\nstill in its infancy, there are many promising examples that show the potential\nfor traditional clinical trials to disappear within a couple of years. \u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Ca href=\"http:\u002F\u002Fhummod.org\u002F\">HumMod\u003C\u002Fa> is one of the most advanced simulations to date. It\nprovides a top-down model of human physiology from whole organs to individual\nmolecules. \u003Cstrong>It features more than 1,500\nequations and 6,500 variables such as body fluids, circulation, electrolytes,\nhormones, metabolism, and skin temperature. HumMod aims to simulate how human\nphysiology works, and claims to be the most sophisticated mathematical model of\nhuman physiology ever created.\u003C\u002Fstrong> Various research projects used HumMod\nalready, for example, to create a heterogeneous population of thousand virtual\npatients by randomly varying physiological parameters to examine \u003Ca href=\"http:\u002F\u002Fhummod.org\u002Fprojects\u002F\">how\nreduced renal mass could play a role in causing salt-sensitive hypertension\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\n\u003Cp>Another great example of the advancement of the field\nis the \u003Ca href=\"https:\u002F\u002Fcordis.europa.eu\u002Fresult\u002Frcn\u002F86061_en.html\">Oncosimulator project\u003C\u002Fa>. The \u003Ca href=\"http:\u002F\u002Fwww.in-silico-oncology.iccs.ntua.gr\u002F\">In Silico Oncology Group\u003C\u002Fa> is developing an in silico experimental platform, as\nwell as an advanced medical decision support tool called Oncosimulator in\ncollaboration with several research centers in Europe and Japan to optimize\ncancer treatment. \u003Cstrong>The oncosimulator is\nan integrated software system simulating in vivo tumor response to therapeutics\nwithin a clinical trial environment. It aims to support clinical\ndecision-making for individual patients. \u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"1500\" height=\"1000\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FVirtual-Humans.jpg\" alt=\"in silico trials\" class=\"wp-image-24543\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FVirtual-Humans.jpg 1500w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FVirtual-Humans-768x512.jpg 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FVirtual-Humans-512x341.jpg 512w\" sizes=\"auto, (max-width: 1500px) 100vw, 1500px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">Source: https:\u002F\u002Fwww.sth.nhs.uk\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\n\n\n\u003Cp>\u003Cstrong>As an excellent cross-industry collaboration, the \u003Ca href=\"https:\u002F\u002Fwww.vph-institute.org\u002Fwhat-is-vph-institute.html\">Virtual Physiological Human Institute\u003C\u002Fa> has to be mentioned.\u003C\u002Fstrong> It is an international non-profit organization, whose mission is to ensure that the Virtual Physiological Human (VPH) is fully realized, universally adopted, and effectively used both in research and clinical settings. Various medical fields can collaborate through the VPH framework, for example, the CARDIOPROOF initiative brought together more than 170 cardiologists to create new, personalized tools for the management of congenital heart disease through advanced computer models. They claim that the web-based application could reduce hospital expenditures by up to 15 percent per patient. Another similar initiative is the \u003Ca href=\"https:\u002F\u002Fsimtk.org\u002Fprojects\u002Fvphop\">Osteoporotic Virtual Physiological Human Project\u003C\u002Fa> to predict the risk of fracture in patients with low bone mass. Nevertheless, the list could go on and on.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">\u003Cstrong>In silico models for regulators?\u003C\u002Fstrong>\u003C\u002Fh2>\n\n\n\n\u003Cp>Recent developments show that not only pharma\ncompanies and medical facilities could make use of in silico medicine. \u003Cstrong>The U.S. Food and Drug Administration also\npicked up on the potential of in silico trials and it’s actively supporting the\ndevelopment of virtual models – for the testing of new medical devices. \u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>Early August, the FDA issued a request for computational software and services modeling the whole human heart to incorporate in a project that aims to evaluate new medical devices and therapies. In 2014, the \u003Ca href=\"https:\u002F\u002Fwww.nextgov.com\u002Femerging-tech\u002F2019\u002F08\u002Ffda-seeks-virtual-heart-test-medical-devices\u002F158946\u002F\">FDA initiated its collaboration with French company Dassault Systémes around their simulated 3D heart model\u003C\u002Fa>, which the duo used to test pacemakers and other cardiovascular devices. Through the new project, researchers will incorporate virtual patients and testing to quicken the pace in which devices are tested and adopted. Ultimately, the agency aims to use digital evidence and computer modeling to tackle the delays and costs that hinder patients from getting their hands on new drugs, treatments, or devices. \u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"1600\" height=\"900\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future.jpg\" alt=\"in silico trials\" class=\"wp-image-24544\" srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future.jpg 1600w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future-370x208.jpg 370w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future-768x432.jpg 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future-1536x864.jpg 1536w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002FNo-Need-For-Lab-Rats-In-The-Future-512x288.jpg 512w\" sizes=\"auto, (max-width: 1600px) 100vw, 1600px\" \u002F>\u003Cfigcaption class=\"wp-element-caption\">No need for lab rats in the future. Source: www.gizmodo.com\u003C\u002Ffigcaption>\u003C\u002Ffigure>\n\n\n\n\u003Cp>We firmly believe that drug development and new therapy experimentation will largely happen through in silico trials in the future, since who would want to test new drugs on animals or humans if we have the possibility to accurately measure the consequences of novel medications or treatment paths virtually. However, we have to mention that regulators will face a new, so far unknown challenge here: they will have to let more and more personalized, cheaper, and more efficient drugs be introduced on the market without being tested on actual humans for years. \u003C\u002Fp>\n\n\n\n\u003Ctable style=\"width: 100%; border-collapse: collapse; background-color: #eee; border-top: 4px solid #444;\" cellpadding=\"10px\">\n\u003Ctbody>\n\u003Ctr>\n\u003Ctd style=\"width: 100%;\">\n\u003Cp>\u003Cstrong>At The Medical Futurist, we are building a community for making a bold vision about the future of healthcare reality today.\u003C\u002Fstrong>\u003C\u002Fp>\n\u003Ciframe loading=\"lazy\" width=\"560\" height=\"315\" src=\"https:\u002F\u002Fwww.youtube.com\u002Fembed\u002FFIbMejImnxs\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen=\"\">\u003C\u002Fiframe>\n\u003Cp>If you’d like to support this mission, we invite you to \u003Ca href=\"https:\u002F\u002Fwww.patreon.com\u002Fthemedicalfuturist\">join The Medical Futurist Patreon Community\u003C\u002Fa>. A community of empowered patients, future-oriented healthcare professionals, concerned health policymakers, sensible health tech developers, and enthusiastic medical students. If there were ever a time to join us, it is now. Every contribution, however big or small, powers our research and sustains our future.\u003C\u002Fp>\n\u003Cp>\u003Ca href=\"https:\u002F\u002Fwww.patreon.com\u002Fthemedicalfuturist\">\u003Cstrong style=\"background-color: #e71d3299; color: #000;\">Click here to support The Medical Futurist from as little as $3\u003C\u002Fstrong>\u003C\u002Fa> – it only takes a minute. Thank you.\u003C\u002Fp>\n\u003C\u002Ftd>\n\u003C\u002Ftr>\n\u003C\u002Ftbody>\n\u003C\u002Ftable>\n\u003Cp> \u003C\u002Fp>\n",false,{"rendered":22,"protected":20},"\u003Cp>Traditional clinical trials are equivalent of billions of dollars and years of hard work with no guarantee for the new drug to be approved by regulatory bodies, not to speak about the dangers of testing medication on animals and\u002For humans. What if we could take a radical turn? What if we conducted clinical trials on virtual bodies that could perfectly mimic human physiology? With the help of artificial intelligence, enhanced computer simulations, and advances in personalized medicine, in silico trials might be a reality in the coming years.\u003C\u002Fp>\n",6,24545,"closed",true,"","standard",{"_acf_changed":20,"footnotes":27},[31,32,33],521,490,489,[35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],313,1154,355,1448,356,134,399,144,444,173,175,206,217,566,246,567,289,677,[],[],[56,57,58,59,60,61,62,63,64],3347,1621,1623,1635,1715,1723,1883,2303,3339,[66,14,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"post-24540","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-future-medicine","category-future-of-pharma","category-personalized-medicine","tag-medicine","tag-medication","tag-personalized-medicine","tag-in-silico","tag-pharma-2","tag-ai","tag-simulation","tag-artificial-intelligence","tag-virtual","tag-clinical","tag-clinical-trial","tag-digital","tag-drug","tag-clinical-trials","tag-future","tag-in-silico-trials","tag-innovation","tag-drugs",{"id":24,"alt_text":94,"caption":27,"description":95,"media_type":96,"media_details":97,"post":5,"source_url":130},"in silico trials, synthetic data, artificial patient, TMF","synthetic data, artificial patient, TMF","image",{"width":98,"height":99,"file":100,"sizes":101,"image_meta":128},1920,1080,"2019\u002F08\u002F103_In-silico-clinical-trials.png",{"medium":102,"large":108,"thumbnail":113,"medium_large":117,"1536x1536":118,"2048x2048":123},{"file":103,"width":104,"height":105,"mime-type":106,"source_url":107},"103_In-silico-clinical-trials-370x208.png","370","208","image\u002Fpng","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-370x208.png",{"file":109,"width":110,"height":111,"mime-type":106,"source_url":112},"103_In-silico-clinical-trials-768x432.png","768","432","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-768x432.png",{"file":114,"width":115,"height":115,"mime-type":106,"source_url":116},"103_In-silico-clinical-trials-150x150.png","150","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-150x150.png",{"file":109,"width":110,"height":111,"mime-type":106,"source_url":112},{"file":119,"width":120,"height":121,"mime-type":106,"source_url":122},"103_In-silico-clinical-trials-1536x864.png","1536","864","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-1536x864.png",{"file":124,"width":125,"height":126,"mime-type":106,"source_url":127},"103_In-silico-clinical-trials-2048x1152.png","2048","1152","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-2048x1152.png",{"aperture":129,"credit":27,"camera":27,"caption":27,"created_timestamp":129,"copyright":27,"focal_length":129,"iso":129,"shutter_speed":129,"title":27,"orientation":129},"0","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2019\u002F08\u002F103_In-silico-clinical-trials-scaled.png",{"related_posts":132,"related_posts_footer":136,"cta_type":27,"cta_color":27,"subtitle":27,"related_books":20},[133,134,135],14131,15585,13095,[137,138,139],15834,17208,11882,{"yoast_wpseo_title":141,"yoast_wpseo_metadesc":142,"yoast_wpseo_canonical":15},"Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future - The Medical Futurist","With the help of A.I., enhanced computer simulations, and advances in personalized medicine, in silico trials might be a reality in the coming years.",{"self":144,"collection":150,"about":153,"author":156,"replies":159,"version-history":162,"predecessor-version":166,"wp:featuredmedia":170,"wp:attachment":173,"wp:term":176,"curies":192},[145],{"href":146,"targetHints":147},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F24540",{"allow":148},[149],"GET",[151],{"href":152},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts",[154],{"href":155},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftypes\u002Fpost",[157],{"embeddable":26,"href":158},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fusers\u002F6",[160],{"embeddable":26,"href":161},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcomments?post=24540",[163],{"count":164,"href":165},7,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F24540\u002Frevisions",[167],{"id":168,"href":169},50061,"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fposts\u002F24540\u002Frevisions\u002F50061",[171],{"embeddable":26,"href":172},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia\u002F24545",[174],{"href":175},"https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fmedia?parent=24540",[177,180,183,186,189],{"taxonomy":178,"embeddable":26,"href":179},"category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcategories?post=24540",{"taxonomy":181,"embeddable":26,"href":182},"post_tag","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Ftags?post=24540",{"taxonomy":184,"embeddable":26,"href":185},"project_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fproject_category?post=24540",{"taxonomy":187,"embeddable":26,"href":188},"contact_email_category","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fcontact_email_category?post=24540",{"taxonomy":190,"embeddable":26,"href":191},"yst_prominent_words","https:\u002F\u002Fapi.medicalfuturist.com\u002Fwp-json\u002Fwp\u002Fv2\u002Fyst_prominent_words?post=24540",[193],{"name":194,"href":195,"templated":26},"wp","https:\u002F\u002Fapi.w.org\u002F{rel}",[197],{"id":139,"date":198,"date_gmt":198,"guid":199,"modified":201,"modified_gmt":202,"slug":203,"status":13,"type":14,"link":204,"title":205,"content":207,"excerpt":209,"author":23,"featured_media":211,"comment_status":212,"ping_status":212,"sticky":20,"template":27,"format":28,"meta":213,"categories":214,"tags":215,"project_category":217,"contact_email_category":218,"yst_prominent_words":219,"class_list":235,"better_featured_image":238,"acf":274,"yoast_meta":275,"_links":277},"2016-01-12T20:58:04",{"rendered":200},"http:\u002F\u002Fscienceroll.com\u002F?p=11882","2021-12-06T00:26:45","2021-12-05T23:26:45","the-future-of-the-fda-and-drug-regulations-2","https:\u002F\u002Fmedicalfuturist.com\u002Fthe-future-of-the-fda-and-drug-regulations-2",{"rendered":206},"The future of the FDA and drug regulations",{"rendered":208,"protected":20},"\n\u003Ctable style=\"width: 100%; border-collapse: collapse; background-color: #eee; border-top: 4px solid #444;\" cellpadding=\"5px\"> \u003Ctbody> \u003Ctr> \u003Ctd style=\"width: 100%;\"> \u003Cp style=\"color: #555;font-size: 12px;line-height: 14px\">THIS ARTICLE HAS NOT BEEN UPDATED SINCE 2016. THE INFORMATION SHARED IN THE ARTICLE WAS ACCURATE AT THE TIME OF ITS PUBLICATION, BUT IT MAY BE OUT OF DATE NOW. \u003Ca href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fmagazine\">BROWSE OUR LATEST ARTICLES HERE\u003C\u002Fa>\u003C\u002Fp> \u003C\u002Ftd> \u003C\u002Ftr> \u003C\u002Ftbody> \u003C\u002Ftable> \u003Cp> \u003C\u002Fp>\n\n\n\n\u003Cp>The system of drug regulation is obsolete. To keep patients around the world safe, authorities like the FDA must step up and deal with disruptive trends – without suffocating innovation.\u003C\u002Fp>\n\n\n\n\u003C!--more-->\n\n\n\n\u003Cp>Innovation in medicine is getting faster while the processes the US \u003Ca href=\"http:\u002F\u002Fwww.fda.gov\u002F\" target=\"_blank\" rel=\"noopener\">Food and Drug Administration\u003C\u002Fa> (FDA) uses are sometimes decades old. The \u003Ca href=\"http:\u002F\u002Fwww.fda.gov\u002FAdvisoryCommittees\u002FCommitteesMeetingMaterials\u002FPatientEngagementAdvisoryCommittee\u002Fdefault.htm\" target=\"_blank\" rel=\"noopener\">Patient Engagement Advisory Committee\u003C\u002Fa>, launched in September 2015, was a great step forward. But regulators are unprepared for some big changes on the horizon.\u003C\u002Fp>\n\n\n\n\u003Cp>Here are the top five issues that I believe will shape the future of the regulatory environment.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-embed\">\u003Cdiv class=\"wp-block-embed__wrapper\">\nhttps:\u002F\u002Fyoutu.be\u002FMFBReMWin4g\n\u003C\u002Fdiv>\u003C\u002Ffigure>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">1) Patients taking action\u003C\u002Fh2>\n\n\n\n\u003Cp>If regulations don’t support the trends and technologies that make lives better, patients will take action themselves. This trend is already apparent, fueled by disruptive technologies like crowdsourcing. There is a chance that patients (or clusters of patient groups) might start acquiring\u002Flaunching biotech companies to develop drugs and conduct clinical trials themselves without waiting for a regulatory agency to pave the way for them.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">2) The ‘Uberification’ of healthcare\u003C\u002Fh2>\n\n\n\n\u003Cp>Uber has caused protests around the world by disrupting the taxi industry through making transportation available at lower prices. The company’s success and price advantage was made possible in no small part through avoiding regulations. If on-demand care delivery services gain popularity in the same way, before proper regulations are put in place, the resulting chaos will threaten patients’ health and caregivers’ livelihoods.\u003C\u002Fp>\n\n\n\n\u003Cp>The FDA will have to be at its best to prevent this. And it must hurry up – The \u003Ca href=\"https:\u002F\u002Fgetheal.com\u002F\" target=\"_blank\" rel=\"noopener\">Heal app\u003C\u002Fa> and \u003Ca href=\"http:\u002F\u002Fwww.go2nurse.com\u002F\" target=\"_blank\" rel=\"noopener\">Go2Nurse\u003C\u002Fa> in Chicago have already started this disruption around how healthcare is delivered.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg decoding=\"async\" src=\"\u002Fwp-content\u002Fmedia\u002F2016\u002F01\u002Fheal-app2.jpg\" alt=\"heal-app2\" class=\"wp-image-11892\"\u002F>\u003C\u002Ffigure>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">3) Wearables\u003C\u002Fh2>\n\n\n\n\u003Cp>The wearable health tracker revolution is changing the healthcare status quo, as medical information is now available outside the ivory tower of medicine which previously kept this information solely in the hands of physicians.\u003C\u002Fp>\n\n\n\n\u003Cp>There might soon be ‘insideables’ – namely, devices implanted into the body or just under the skin. There are already people who have had RFID chips implanted to enable them to open up a laptop, a smartphone or even the garage door. Another trend is that of ‘digestibles’ – pills or tiny gadgets that can be swallowed to track digestion and the absorption of drugs.\u003C\u002Fp>\n\n\n\n\u003Cp>So far, the FDA has not been keen on regulating the wearable market heavily. But when such disruptive technologies hit the market, it will be years behind.\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">4) Direct-to-consumer genomic services\u003C\u002Fh2>\n\n\n\n\u003Cp>When the FDA shot down all direct-to-consumer (DTC) services from the likes of 23andMe and Navigenics, there was a belief that it would soon provide a regulatory framework for such services. But, two years on, these companies function on thin ice.\u003C\u002Fp>\n\n\n\n\u003Cp>While the freedom to access information about our health is crucial, regulatory agencies must make sure that the data patients receive is accurate and is discussed with a genetic counselor or physician. Otherwise, patients might interpret results wrongly. In five-to-10 years, genome sequencing will become accessible to almost everyone, and won’t be limited to big companies with serious capital. When that time comes, the FDA will face a serious scenario in which patients access the information in their DNA and analyse it at home with services like IBM Watson. They won’t need to involve any healthcare professional. But lifestyle and medical decisions based on such information will still require expertise that only trained physicians bring.\u003Cbr>\u003Cbr>\u003Cbr>\u003Ca class=\"img\" href=\"https:\u002F\u002Fmedicalfuturist.leadpages.co\u002Fleadbox\u002F141dd0f73f72a2%3A123305c6d346dc\u002F5736907271045120\u002F\" target=\"_blank\" rel=\"noopener\">\u003Cimg loading=\"lazy\" decoding=\"async\" class=\"bigger alignnone wp-image-13076 size-full\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002F40_trends_banner1_onlybutton.png\" alt=\"Free guide and infographic: 40 trends of the future of medicine\" width=\"2000\" height=\"775\"\u003C\u002Fa srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002F40_trends_banner1_onlybutton.png 870w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002F40_trends_banner1_onlybutton-768x297.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002F40_trends_banner1_onlybutton-512x198.png 512w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002F40_trends_banner1_onlybutton-458x177.png 458w\" sizes=\"auto, (max-width: 2000px) 100vw, 2000px\" \u002F>\u003C\u002Fa>\u003Cscript src=\"https:\u002F\u002Fmedicalfuturist.leadpages.co\u002Fleadbox-1011.js\" type=\"text\u002Fjavascript\" data-leadbox=\"141dd0f73f72a2:123305c6d346dc\" data-url=\"https:\u002F\u002Fmedicalfuturist.leadpages.co\u002Fleadbox\u002F141dd0f73f72a2%3A123305c6d346dc\u002F5736907271045120\u002F\" data-config=\"%7B%7D\">\u003C\u002Fscript>\u003Cbr>\u003Cbr>\u003C\u002Fp>\n\n\n\n\u003Ch2 class=\"wp-block-heading\">5) Real-time data gathered by insurance companies\u003C\u002Fh2>\n\n\n\n\u003Cp>Insurance companies such as \u003Ca href=\"https:\u002F\u002Fwww.hioscar.com\u002F\" target=\"_blank\" rel=\"noopener\">Oscar Health\u003C\u002Fa> have started issuing wearables to their customers, and offering incentives and rewards (like an Amazon gift card) if the customers agree to share their data obtained from health trackers. This motivates the patient to live a healthier life and doesn’t require strict regulation. But current wearable technology only provides harmless information about the wearer’s health, like steps taken or heart rate.\u003C\u002Fp>\n\n\n\n\u003Cfigure class=\"wp-block-image\">\u003Cimg decoding=\"async\" src=\"\u002Fwp-content\u002Fmedia\u002F2016\u002F01\u002Foscar_flash-1024x576.png\" alt=\"oscar_Flash-1024x576\" class=\"wp-image-11895\"\u002F>\u003C\u002Ffigure>\n\n\n\n\u003Cp>What will happen when every health parameter and vital sign can be constantly monitored using next-generation wearables, like digital tattoos? It’s great seeing companies backing preventive medicine, but keeping patients’ information private is crucial.\u003C\u002Fp>\n\n\n\n\u003Cp>The \u003Ca href=\"https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FGenetic_Information_Nondiscrimination_Act\" target=\"_blank\" rel=\"noopener\">Genetic Information Nondiscrimination Act\u003C\u002Fa> (GINA) is a step in the right direction. The US law makes sure patients do not share genetic test results with their employers and insurance companies, as that could be used to personalize their insurance rates, punishing them, for example, for inherent genetic defects that they were born with.\u003C\u002Fp>\n\n\n\n\u003Cp>But similar regulation that encompasses any health parameter will be much harder.\u003C\u002Fp>\n\n\n\n\u003Cp>The progress of technology cannot be stopped. Similarly, we all want healthcare to be safe, affordable and efficient. However, to regulate these disruptive trends without stifling innovation, the FDA must have the clearest vision and the best knowledge about healthcare trends.\u003C\u002Fp>\n\n\n\n\u003Cp>\u003Cstrong>The biggest challenge today is that the regulators are not at the forefront of innovation and they cannot hope to anticipate and regulate changes that they don’t yet understand.\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>I recently published this article on \u003Ca href=\"http:\u002F\u002Fwww.pharmaphorum.com\u002Farticles\u002Fthe-future-of-the-fda-and-drug-regulations\" target=\"_blank\" rel=\"noopener\">Pharmaphorum.com\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\n\u003Cdiv class=\"wp-block-image\">\u003Cfigure class=\"aligncenter\">\u003Ca class=\"img\" href=\"https:\u002F\u002Fmedicalfuturist.com\u002Fhealthcare-keynote-speaker\" target=\"_blank\" rel=\"noopener\">\u003Cimg loading=\"lazy\" decoding=\"async\" width=\"870\" height=\"204\" src=\"https:\u002F\u002F1712507217.rsc.cdn77.org\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002Fspeaker_v3.png\" alt=\"Work with Dr. Bertalan Mesko, top healthcare speaker\" class=\"wp-image-13419\"\u002F\u003C\u002Fa srcset=\"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002Fspeaker_v3.png 870w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002Fspeaker_v3-768x180.png 768w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002Fspeaker_v3-512x120.png 512w, https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F04\u002Fspeaker_v3-458x108.png 458w\" sizes=\"auto, (max-width: 870px) 100vw, 870px\" \u002F>\u003C\u002Fa>\u003C\u002Ffigure>\u003C\u002Fdiv>\n",{"rendered":210,"protected":20},"\u003Cp>THIS ARTICLE HAS NOT BEEN UPDATED SINCE 2016. THE INFORMATION SHARED IN THE ARTICLE WAS ACCURATE AT THE TIME OF ITS PUBLICATION, BUT IT MAY […]\u003C\u002Fp>\n",12385,"open",{"_acf_changed":20,"footnotes":27},[32],[216],519,[],[],[220,221,222,223,224,225,226,227,228,229,230,231,232,233,234],1979,1987,2991,2993,3207,3857,1571,5067,1613,5179,1631,5387,1683,5965,1969,[236,14,67,68,69,70,71,73,237],"post-11882","tag-gc4",{"id":211,"alt_text":27,"caption":239,"description":27,"media_type":96,"media_details":240,"post":139,"source_url":273},"The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS\u002FJason Reed   (UNITED STATES HEALTH) - RTXQCTX",{"width":241,"height":242,"file":243,"sizes":244,"image_meta":271},870,537,"2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington.jpg",{"medium":245,"large":251,"thumbnail":256,"medium_large":260,"large_old_512x316":261,"medium_old_405x250":266},{"file":246,"width":247,"height":248,"mime-type":249,"source_url":250},"the-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-370x208.jpg",370,208,"image\u002Fjpeg","https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-370x208.jpg",{"file":252,"width":253,"height":254,"mime-type":249,"source_url":255},"the-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-768x474.jpg",768,474,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-768x474.jpg",{"file":257,"width":258,"height":258,"mime-type":249,"source_url":259},"the-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-150x150.jpg",150,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-150x150.jpg",{"file":252,"width":253,"height":254,"mime-type":249,"source_url":255},{"file":262,"width":263,"height":264,"mime-type":249,"source_url":265},"the-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-512x316.jpg",512,316,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-512x316.jpg",{"file":267,"width":268,"height":269,"mime-type":249,"source_url":270},"the-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-405x250.jpg",405,250,"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington-405x250.jpg",{"aperture":129,"credit":27,"camera":27,"caption":27,"created_timestamp":129,"copyright":27,"focal_length":129,"iso":129,"shutter_speed":129,"title":27,"orientation":129,"keywords":272},[],"https:\u002F\u002Fcdn.medicalfuturist.com\u002Fwp-content\u002Fuploads\u002F2016\u002F01\u002Fthe-headquarters-of-the-u.s.-food-and-drug-administration-is-shown-in-silver-spring-near-washington.jpg",{"cta_type":27,"cta_color":27,"subtitle":27,"related_books":20,"related_posts_footer":20,"related_posts":20},{"yoast_wpseo_title":276,"yoast_wpseo_metadesc":27,"yoast_wpseo_canonical":204},"The future of the FDA and drug regulations - 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