{"id":74068,"date":"2026-05-29T08:47:16","date_gmt":"2026-05-29T08:47:16","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/74068\/"},"modified":"2026-05-29T08:47:16","modified_gmt":"2026-05-29T08:47:16","slug":"ais-next-pharma-challenge-tackling-costly-and-risky-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/74068\/","title":{"rendered":"AI\u2019s next pharma challenge: tackling costly and risky clinical trials"},"content":{"rendered":"<p>    <img src=\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/05\/707645125_highres-1.jpg\" width=\"1300\" height=\"867\" alt=\"pathology slide\" loading=\"eager\" decoding=\"sync\" fetchpriority=\"high\"\/><\/p>\n<p>                The Digital Medicine department at the University of Bern among other universities are increasingly using AI to analyse patient tissue samples.            <\/p>\n<p>            Keystone \/ Gaetan Bally        <\/p>\n<p>        AI has transformed the search for new medicines. Now drug companies are betting it can fix the slow, expensive process of testing them in humans.\n<\/p>\n<p>            Listen to the article        <\/p>\n<p>            Listening the article        <\/p>\n<p>                Toggle language selector            <\/p>\n<p>                            English (US)                        <\/p>\n<p>                            English (British)                        <\/p>\n<p>            Generated with artificial intelligence.        <\/p>\n<p>        This content was published on    <\/p>\n<p>        May 29, 2026 &#8211; 09:00\n<\/p>\n<p>Ask a pharmaceutical company about the current approach to clinical trials and you\u2019re likely to hear a chorus of complaints about a broken and dysfunctional system. It takes on average at least a decade and <a href=\"https:\/\/www.cbo.gov\/publication\/57126\" target=\"_blank\" rel=\"nofollow noopener\">roughlyExternal link<\/a> $1-2 billion (CHF790 million-1.6 billion) to develop a new drug. Around 60-70% of that time is spent in the three phases of human testing. The longer a clinical trial takes, the longer it takes for that medicine to reach patients.<\/p>\n<p>To make matters worse, companies often waste time and money on trials for drugs that aren\u2019t ultimately approved by regulators. For every 100 drugs that begin human trials, about 90 aren\u2019t given the green light because the tests fail to prove the medicines are safe or effective.<\/p>\n<p>\u201cThe industry has just accepted that risk and failure are a part of drug development because there has been no other option,\u201d said Kevin Buyens, co-founder and Chief Business Officer at AI biotech TwinEdge Bioscience in western Switzerland. \u201cBut this is changing. Digital technologies can help fill the gap.\u201d<\/p>\n<p>Artificial intelligence, especially machine-learning systems, have already helped scientists identify promising drug candidates by sifting through huge volumes of chemical and biological data far faster than humans.<\/p>\n<p>\n    More<\/p>\n<p>    <img src=\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/05\/307312.jpeg\" width=\"5760\" height=\"3840\" alt=\"pharma lab\" loading=\"lazy\" decoding=\"async\" fetchpriority=\"auto\"\/><\/p>\n<p>        More    <\/p>\n<p>        Big Pharma steps up race for AI-discovered drugs    <\/p>\n<p class=\"teaser-wide-card__excerpt\">\n<p>                        This content was published on                    <\/p>\n<p>                        May 30, 2024                    <\/p>\n<p>                AI is speeding up drug discovery but bringing an AI-discovered drug to market won\u2019t happen overnight.            <\/p>\n<p>    <a class=\"teaser-wide-card__link\" href=\"https:\/\/www.swissinfo.ch\/eng\/archive-multinational-companies\/big-pharma-steps-up-race-for-ai-discovered-drugs\/79014204\" target=\"_self\" rel=\"nofollow noopener\"><\/p>\n<p>            Read more: Big Pharma steps up race for AI-discovered drugs<br \/>\n    <\/a><\/p>\n<p>The situation is different in clinical trials. Regulators like the US Food and Drug Administration (FDA) and Swissmedic use information collected in trials to decide whether a drug is safe or effective enough to be given to patients. Regulators have been wary of any shortcuts that could jeopardise patient safety.<\/p>\n<p>But in the last few years, AI technologies have dramatically improved alongside better access to so-called real-world data, such as electronic health records. This has increased confidence in AI\u2019s ability to speed up trials and improve their success rate.<\/p>\n<p>In April, the FDA, the world\u2019s largest medicines regulator, announced plans for <a href=\"https:\/\/public-inspection.federalregister.gov\/2026-08281.pdf\" target=\"_blank\" rel=\"nofollow noopener\">a pilot programmeExternal link<\/a> to assess how AI-enabled technologies can improve efficiency, speed and the quality of decision-making in early-phase clinical trials.<\/p>\n<p>While limited in scope, the initiative is one of the clearest signs yet that regulators are becoming more open to the use of AI in clinical trials to unblock what the FDA describes as a \u201ccritical bottleneck\u201d in drug development. It also comes as China is emerging as an important force in early-stage clinical trials because of its ability to conduct them faster and cheaper.<\/p>\n<p>Why trials take so long<\/p>\n<p>Clinical trials have traditionally been a long, drawn-out process for a host of reasons. One major factor is simply the large amount of paperwork, much of which is done manually. The situation has gotten worse as trials are more global, drugs are more complex, and authorities are <a href=\"https:\/\/www.n-side.com\/en\/insights\/why-clinical-trial-timelines-are-getting-longer-and-how-to-fix-it\/\" target=\"_blank\" rel=\"nofollow noopener\">demandingExternal link<\/a> more information to assess a therapy\u2019s risks and benefits.<\/p>\n<p>        <img src=\"https:\/\/www.swissinfo.ch\/content\/wp-content\/uploads\/sites\/13\/2026\/05\/clinical_trial_process-eng.svg?ver=c4f449c0\" width=\"1080\" height=\"1476\" alt=\"\" loading=\"lazy\" decoding=\"async\" fetchpriority=\"auto\"\/><\/p>\n<p>                Illustration: Kai Reusser, Swissinfo        <\/p>\n<p>Almost half of the time between a Phase 1 trial and an FDA application for approval is \u201cdead time\u201d consumed by paperwork and data transfers, <a href=\"https:\/\/www.bmj.com\/content\/393\/bmj.s855\" target=\"_blank\" rel=\"nofollow noopener\">accordingExternal link<\/a> to former FDA Commissioner Marty Makary. Finding eligible patients and sites is also a problem \u2013 studies <a href=\"https:\/\/www.researchgate.net\/publication\/396369004_Artificial_intelligence_in_clinical_trials_A_comprehensive_review_of_opportunities_challenges_and_future_directions\" target=\"_blank\" rel=\"nofollow noopener\">findExternal link<\/a> that 80% of trials experience significant delays due to challenges enrolling patients.<\/p>\n<p>Scientists also struggle to predict how patients will respond to a drug. Many trials recruit patients who end up not benefiting from a new drug, which leads to higher failure rates and millions of dollars wasted on unsuccessful testing.<\/p>\n<p>A stark example is Alzheimer\u2019s disease. A <a href=\"https:\/\/alz-journals.onlinelibrary.wiley.com\/doi\/10.1002\/alz.12450\" target=\"_blank\" rel=\"nofollow noopener\">studyExternal link<\/a> found that from 1995 to 2021, some $42.5 billion in private money was spent on over 1,000 clinical trials for Alzheimer\u2019s drug candidates, with 57% of that money spent in Phase 3 trials. Some 184,000 participants took part in the trials for the 235 drug candidates, 95% of which failed to be approved.<\/p>\n<p>AI to the rescue?<\/p>\n<p>Over the past decade, a growing number of companies and start-ups have been trying to figure out how AI can tackle some of these problems. One key area that has seen widespread uptake is the use of AI to write protocols \u2013 the detailed study plans researchers use to design and run clinical trials. Writing one typically takes 6-12 months.<\/p>\n<p>        More    <\/p>\n<p>            Do you trust AI with your health?        <\/p>\n<p class=\"teaser-wide-debate-card__text\">\n<p>                People are starting to use AI for health advice with mixed results. What has been your experience with AI for health information?\n        <\/p>\n<p>    <a class=\"teaser-wide-debate-card__link\" href=\"https:\/\/www.swissinfo.ch\/eng\/healthcare-innovation\/do-you-trust-ai-with-your-health\/91378404\" rel=\"nofollow noopener\" target=\"_blank\"><\/p>\n<p>             View the discussion<br \/>\n    <\/a><\/p>\n<p>Swiss startup <a href=\"https:\/\/www.risklick.ch\/\" target=\"_blank\" rel=\"nofollow noopener\">RisklickExternal link<\/a>\u00a0created Protocol AI, a software that uses generative AI to develop multiple scenarios for a study design. The tool has been tested by Swiss biotech firm Debiopharm, which is now integrating it across the company. Risklick says the tool can reduce the time and cost involved in developing clinical trial protocols by up to 35%.<\/p>\n<p>AI is also starting to be used to improve patient recruitment. US start-up Paradigm Health has developed an AI-powered platform to help pharmaceutical companies identify eligible trial participants. It relies on electronic health records from a vast network of cancer clinics.<\/p>\n<p>Other AI-powered platforms such as Switzerland-based <a href=\"https:\/\/www.ancora.ai\/en?partner=ancora_ai\" target=\"_blank\" rel=\"nofollow noopener\">Ancora.aiExternal link<\/a> and TrialGPT developed by the US National Institutes of Health are empowering patients to find trials for their specific condition and city. <a href=\"https:\/\/www.nature.com\/articles\/s41467-024-53081-z\" target=\"_blank\" rel=\"nofollow noopener\">StudiesExternal link<\/a> have found TrialGPT matches patients to trials almost as accurately as human experts in 40% less time. Since 2022, over 23,000 people from 101 countries have used Ancora to search for cancer trials.<\/p>\n<p>Biology AI company Owkin, which has offices in Geneva, has built deep-learning models that are being used to predict patient outcomes but also identify what factors influence those outcomes. It has now signed partnerships with several big pharma companies to customise these AI models for clinical trial decisions.<\/p>\n<p>Swiss pharma giant Novartis, which runs studies that involve thousands of people, has built what it calls the Intelligent Decision System, which is like a computational twin of the entire clinical trial process. The system can simulate parts of a clinical trial to compare likely outcomes at different site locations and troubleshoot potential problems, such as a site dropping out of a trial.<\/p>\n<p>\u201cEvery day you can gain in a clinical trial is one less day the patient has to wait for a drug, so you want to speed up trials as much as possible,\u201d Robert McGregor, who leads the company\u2019s Intelligent Decision System, told Swissinfo. \u201cIf I change an assumption in my study design, it can completely change the timeline.\u201d<\/p>\n<p>Pharmaceutical companies have been more cautious about using AI in ways that could directly influence regulatory decisions. This includes computational models that simulate how virtual groups of patients might respond to a drug, which could help predict trial outcomes before human testing begins, or even reduce the number of patients needed in some trials.<\/p>\n<p>At an even more personalised level, AI can create digital twins \u2013\u00a0virtual, dynamic replicas of humans using a mathematical model and a combination of genomic, clinical, and imaging data from real patients. Researchers hope these models can predict how individual patients respond to a drug or even simulate what happens if they receive a placebo instead.<\/p>\n<p>Some companies have started to develop these for research purposes.<\/p>\n<p>TwinEdge Bioscience, founded in 2025, is developing digital twins of individual patient tumours based on molecular data from cancer patients. The company is partnering with pharma companies to test hypotheses about drug targets and truly addressable patients.<\/p>\n<p>\n    More<\/p>\n<p>    <img src=\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/05\/536007175_highres.jpg\" width=\"1300\" height=\"867\" alt=\"AI in healthcare and machine learning in medicine\" loading=\"lazy\" decoding=\"async\" fetchpriority=\"auto\"\/><\/p>\n<p>        More    <\/p>\n<p>        Swiss AI\n        <\/p>\n<p>        Major new initiative aims to bring AI to cancer treatment in Switzerland    <\/p>\n<p class=\"teaser-wide-card__excerpt\">\n<p>                        This content was published on                    <\/p>\n<p>                        Oct 30, 2025                    <\/p>\n<p>                Despite the buzz around AI in medicine, cancer patients in Switzerland rarely encounter it. A national project aims to change this.            <\/p>\n<p>    <a class=\"teaser-wide-card__link\" href=\"https:\/\/www.swissinfo.ch\/eng\/swiss-ai\/major-new-initiative-aims-to-bring-ai-to-cancer-treatment-in-switzerland\/90175712\" target=\"_self\" rel=\"nofollow noopener\"><\/p>\n<p>            Read more: Major new initiative aims to bring AI to cancer treatment in Switzerland<br \/>\n    <\/a><\/p>\n<p>SOPHiA GENETICS, which was founded as a start-up out of the Swiss Federal Institute of Technology Lausanne (EPFL) in 2011 and went public in 2021, launched digital twin technology last October. The platform uses each patient\u2019s unique clinical, biological, imaging, and genomic data collected from hundreds of hospitals to simulate treatment responses.<\/p>\n<p>\u201cAs an industry, we need to embrace real-world data,\u201d said Jurgi Camblong, the company\u2019s founder. \u201cWith this, we can learn things about how to better prescribe or combine drugs, identify sub-populations that would benefit from a drug, and potentially validate that in a clinical trial.\u201d<\/p>\n<p>US-based firm Unlearn has partnered with pharma companies including <a href=\"https:\/\/assets.website-files.com\/5ef3f3eba7c8fa472d1ff536\/62d99a047afe26a83a30e5e6_Unlearn_Roche_AD_Case_Study.pdf\" target=\"_blank\" rel=\"nofollow noopener\">Basel-based RocheExternal link<\/a> to generate digital twins that model real patients\u2019 responses to Alzheimer drug candidates based on real-world data. Results suggest digital twins can reduce control arm sizes by around 35%.<\/p>\n<p>The hurdles to AI adoption in trials<\/p>\n<p>Despite the potential benefits, AI\u2019s ability to transform clinical trials still faces constraints. One is gaps in scientists\u2019 understanding of human biology.<\/p>\n<p>\u201cIf you understand biology, you can run better clinical trials because you know which population and disease you are targeting,\u201d said Thomas Clozel, founder and CEO of Owkin. But, he added, \u201cwe still have little idea why patients develop Alzheimer\u2019s or why some cancers return.\u201d<\/p>\n<p>Data bottlenecks are also an issue. More data is being generated but isn\u2019t necessarily available for clinical research due to privacy laws, and much of it isn\u2019t \u201cAI-ready\u201d \u2013\u00a0formatted in a way that an AI model can use.<\/p>\n<p>Even if AI models perform well, regulators still need to understand how they reach their conclusions. That is difficult when many AI systems operate as a \u201cblack box,\u201d generating information in a way that is opaque or hard to understand.<\/p>\n<p>Nevertheless, regulators are increasingly open to testing new ideas, as reflected in the FDA\u2019s April announcement. The European Medicines Agency has also <a href=\"https:\/\/www.clinicaltrialsarena.com\/news\/ema-qualifies-unlearn-approach\/\" target=\"_blank\" rel=\"nofollow noopener\">signalled opennessExternal link<\/a> to using digital twins for rare disease trials. Swissmedic is also <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/de\/home\/humanarzneimittel\/authorisations\/artificiel-intelligence.html\" target=\"_blank\" rel=\"nofollow noopener\">actively engagedExternal link<\/a> in the development of international AI principles for clinical trials.<\/p>\n<p>\u201cI\u2019m optimistic that in the next few years the way we do clinical trials will change,\u201d said Buyens. \u201cWhen we see real validation studies of these technologies, it will be impossible for regulators to ignore them.\u201d<\/p>\n<p>Edited by Nerys Avery\/vm\/gw<\/p>\n<p>        Articles in this story    <\/p>\n","protected":false},"excerpt":{"rendered":"The Digital Medicine department at the University of Bern among other universities are increasingly using AI to analyse&hellip;\n","protected":false},"author":2,"featured_media":74069,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4],"tags":[101,2850,596,114,1002,461,1434,41,17,3783,21740],"class_list":["post-74068","post","type-post","status-publish","format-standard","has-post-thumbnail","category-switzerland","tag-article","tag-beat-ai-and-medicine","tag-beat-healthcare-innovation","tag-business","tag-health","tag-production-type-original","tag-sci-tech","tag-swiss","tag-switzerland","tag-tpt","tag-user-need-explain-it-to-me"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116656999520149642","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/74068","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=74068"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/74068\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/74069"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=74068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=74068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=74068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}