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Why does it take a new drug 10 years, on average, to come to market?\u00a0Part of the reason lies in the\u00a0dead time\u00a0in the process.\u00a0\u00a0<\/p>\n
Historically, trials have\u00a0required\u00a0tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a\u00a0Phase 1 trial until final submission\u00a0is spent without any ongoing clinical trial in progress \u2014 idle time in the system.\u00a0\u00a0\u00a0<\/p>\n
On\u00a0Tuesday\u00a0the\u00a0Food and Drug Administration announced a\u00a0bold\u00a0new approach\u00a0that\u00a0could\u00a0fundamentally transform\u00a0the development of\u00a0new treatments:\u00a0real-time\u00a0clinical\u00a0trials.\u00a0<\/p>\n
For the first time, FDA regulators will\u00a0be able to see\u00a0what\u2019s\u00a0happening in a clinical trial, looking at endpoints in the cloud\u00a0as they occur. This is\u00a0an important step\u00a0toward our broader goal of\u00a0moving toward continuous trials, reducing\u00a0dead time\u00a0in the system.\u00a0\u00a0<\/p>\n
This approach uses modern technology\u00a0to challenge the\u00a0deeply held\u00a0assumption that new cures require a long wait.\u00a0We believe powerful treatments can reach patients faster without cutting any corners on safety.\u00a0\u00a0<\/p>\n
During my career as a surgical oncologist at Johns Hopkins, I\u00a0monitored\u00a0my patients in the operating room and the intensive care unit using continuous, real-time data. If a patient\u2019s vitals dropped, we intervened\u00a0immediately. We\u00a0didn\u2019t\u00a0wait for a retrospective report to be mailed to us weeks later. Why should the regulatory oversight of powerful experimental drugs be any different?\u00a0<\/p>\n
In my career,\u00a0I\u2019ve\u00a0had to inform patients of a new cancer diagnosis more than a thousand times. It never got easier. Every time, I wondered: \u201cWhy can\u2019t we, as a modern society, figure out a way to make powerful treatments available sooner to those who are willing to try them?\u201d Those experiences had a profound impact on my thinking and have shaped our reforms.\u00a0\u00a0<\/p>\n
By viewing safety signals and clinical endpoints in real time, FDA scientists can detect adverse reactions sooner,\u00a0potentially\u00a0enhancing patient safety. Conversely, when\u00a0a new therapy\u00a0is showing\u00a0strong\u00a0efficacy, we can\u00a0identify\u00a0that success\u00a0rapidly. Real-time trials are not just technically possible; they are transformative for the entire clinical ecosystem.\u00a0<\/p>\n
On Tuesday\u00a0we\u00a0unveiled\u00a0the successful initiation of\u00a0a\u00a0proof-of-concept clinical trial,\u00a0conducted by\u00a0AstraZeneca\u00a0with participation\u00a0from\u00a0the\u00a0University of Texas MD Anderson Cancer Center and the University of Pennsylvania,\u00a0that will report endpoints and data signals to the FDA in real time. Working closely with\u00a0the sponsor, the FDA has\u00a0established\u00a0the technical framework \u2014 powered by improvements in artificial intelligence and modern data science \u2014 to securely stream and\u00a0validate\u00a0key safety and efficacy signals as these trials progress.\u00a0Another is being set up with Amgen.\u00a0\u00a0<\/p>\n
We are not stopping with these two proof-of-concept trials. To build on this success, we will be launching a broader\u00a0real-time clinical trials\u00a0pilot program this summer that will evaluate expanded cloud-based systems, define standardized metrics for success, and bring more sponsors into this new, dynamic regulatory paradigm.\u00a0<\/p>\n
By coupling these design principles with real-time data streaming, we can bring\u00a0unbroken drug\u00a0development to all disease areas. Whether we are fighting rare genetic disorders, autoimmune diseases, or widespread chronic conditions, continuous trials will ensure that data informs decisions instantly. We can learn from every single patient in real time, minimize exposure to ineffective doses, and drastically accelerate the delivery of cures.\u00a0<\/p>\n
This initiative\u00a0represents\u00a0one part of our\u00a0FDA\u00a0common sense modernization campaign.\u00a0We\u00a0have already replaced onerous animal testing requirements with computational modeling and other newer methodologies, reduced burdensome requirements for biosimilars, and\u00a0launched a new\u00a0National\u00a0Priority\u00a0Voucher pilot program\u00a0to get review decisions out in one to two months instead of the typical 10 months to a year.\u00a0Six drugs have already been approved, including\u00a0zongertinib, a lung cancer drug\u00a0that can bring patients out of hospice, and\u00a0Otarmeni, which can restore hearing to\u00a0some children with genetic hearing loss.\u00a0Patients who can potentially\u00a0benefit\u00a0from these game-changing new therapies deserve an FDA that is modern and efficient.\u00a0\u00a0<\/p>\n
These reforms also hold promise to lower drug prices for everyday Americans. That\u2019s\u00a0because\u00a0these reforms lower R&D costs \u2014 savings that can be passed on to patients.\u00a0<\/p>\n
The future of medicine should not be kept waiting. At the FDA, we are ensuring it arrives in real time.\u00a0<\/p>\n
Marty Makary, M.D., M.P.H., is commissioner of the Food and Drug Administration.<\/em><\/p>\n<\/div>\n Why does it take a new drug 10 years, on average, to come to market?\u00a0Part of the reason lies in the\u00a0dead time\u00a0in the process.\u00a0\u00a0 Historically, trials have\u00a0required\u00a0tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a\u00a0Phase 1 trial until final submission\u00a0is spent without any ongoing clinical trial in […]<\/p>\n","protected":false},"author":1,"featured_media":85983,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_daextam_enable_autolinks":"","jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2],"tags":[],"class_list":["post-85982","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/diyhaven858.wasmer.app\/wp-content\/uploads\/2026\/04\/AdobeStock_549112106-1024x576.jpeg","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts\/85982","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/comments?post=85982"}],"version-history":[{"count":0,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/posts\/85982\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/media\/85983"}],"wp:attachment":[{"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/media?parent=85982"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/categories?post=85982"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/diyhaven858.wasmer.app\/index.php\/wp-json\/wp\/v2\/tags?post=85982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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