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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The effort is designed to nix barriers, reduce costs and help effective treatments reach patients sooner. An Oct. 15 webinar will allow stakeholders to offer ideas to help achieve program goals. HHS launched a multi-component effort intended to improve the speed and efficiency with which clinical trials are conducted. The series of initiatives is designed to eliminate duplication, ensure more efficient enrollment and provide patients with earlier access to promising therapies.
\u201cThe goal is straightforward \u2014 generate rigorous evidence faster, reduce unnecessary costs and burdens, and make the United States the best place in the world to engage in clinical trial research,\u201d HHS Secretary Robert F. Kennedy Jr. said during a launch event held at UT Dell Medical Center in Texas. Clinical development for drugs and biologics in the U.S. can take a decade and cost up to $2 billion, but 90% of drugs that start the process ultimately fail, Kennedy said. The system \u201ctakes far too long, costs too much and asks too much of patients,\u201d he said, adding that a more efficient approach is necessary to ensure the U.S. research enterprise can compete with other countries. \u201cWe want to move from a system built around disconnected trials, repetitive processes and fragmented data to one built around reusable infrastructure, secure information, adaptive research, wider patient access and easier patient recruitment.\u201d The reforms fall under an umbrella program called SURPASS, the core objectives of which are to build continuous adaptive-platform trials that incorporate predictive computational models, shared trial infrastructure, common control groups and real-time analysis. The program will aim to: integrate digital twins and other predictive models into trial design to simulate outcomes prior to launch and develop evidence necessary to support regulatory confidence in this effort; enable real-time or on-demand analysis that can support rapid trial adaptation and minimize the need for large conventional control groups; and create what HHS calls an \u201cagentic operations layer\u201d to reduce costs and time through several strategies, such as automating important trial start-up and accelerating data collection. \u201cInstead of treating every trial like an isolated project, SURPASS will … help researchers identify ineffective or unsafe therapies much earlier, concentrate resources on treatments that show promise, and reduce the time and number of participants that is required to reach a reliable, dependable conclusion,\u201d Kennedy said. The Advanced Research Projects Agency for Health (ARPA-H) \u2014 an agency the Biden administration created within HHS to drive high-impact biomedical and health breakthroughs \u2014 will seek ideas from leaders in clinical trial design, operations and regulation, as well as those with expertise in AI and statistics, to help achieve program goals. An informational webinar will be held Oct. 15. Federal officials also outlined three other separate but complementary initiatives intended to address infrastructure challenges \u2014 branded as STACK, COMMONS and CINCH \u2014 that extend beyond clinical trial design. STACK aims to incorporate AI to accelerate trial site activation and help research-naive sites become capable of conducting studies, with the goal of helping more patients access research closer to home. COMMONS will focus on improving infrastructure for connecting and sharing health data nationwide, relying on a privacy-by-design framework to establish research-ready databases. CINCH aims to help patients contribute their own real-world data \u2014 often spread across multiple institutions \u2014 to support care continuity and coordination and make it easier to identify trials that may be appropriate for them. Together, these efforts could shorten the clinical trial timeline from a decade to 4 years or less, according to SURPASS program manager Daria Fedyukina, PhD. \u201cWhy do we have to build clinical trial infrastructure every time we do a trial and then dismantle it completely without reusing it for another trial?\u201d Fedyukina said during the launch event. \u201cWhy do we have to enroll patients in placebo or control arms even in situations when we already have enough data accumulated to learn from it? Why do we need to wait to complete a trial when, in the middle of a trial, we have already discovered if a treatment is working? We really can do much better.\u201d During a panel discussion that followed the unveiling of SURPASS and the complementary initiatives, Nilay Shah, PhD, chief strategy officer at UT Dell Medical School, outlined multiple hurdles in clinical trial design and conduct that SURPASS and the complementary efforts could help address. \u201cOne of the challenges [these initiatives] are trying to solve is how do we get to activation quicker,\u201d Shah said. \u201cThat is a really important piece because each trial, over and over, requires the same infrastructure \u2014 especially from the health care system side. They\u2019re spending a lot of resources to activate each trial. \u201cThe second piece is, how do you enable better enrollment?\u201d Shah added. \u201cHow do you take trials to the community, leverage community health workers and other approaches to bring trials to people instead of waiting for them to come to a large health system or academic medical center where the trial might be running?\u201d Over the past decade, more drug developers have been moving early-stage trials overseas \u201cto escape the regulatory and administrative friction of an outdated system here at home,\u201d acting FDA Commissioner Kyle Diamantas said during the event. SURPASS and the other complementary initiatives are an important step toward establishing a clinical trials ecosystem that is \u201cfast, adaptive and proudly anchored to the United States,\u201d Diamantas said. \u201cWhen trials move across the globe, it is more challenging for FDA to verify that the data from those trials are reliable,\u201d Diamantas said. \u201cModernizing regulatory science is not about cutting<\/p>\n","protected":false},"author":1,"featured_media":3878,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3877","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3877","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3877"}],"version-history":[{"count":0,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3877\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/media\/3878"}],"wp:attachment":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3877"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3877"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3877"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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