{"id":2884,"date":"2026-01-15T15:58:26","date_gmt":"2026-01-15T15:58:26","guid":{"rendered":"https:\/\/americanvoiceofhealth.com\/index.php\/2026\/01\/15\/real-world-answers-for-patients-running-out-of-time\/"},"modified":"2026-01-15T15:58:26","modified_gmt":"2026-01-15T15:58:26","slug":"real-world-answers-for-patients-running-out-of-time","status":"publish","type":"post","link":"https:\/\/americanvoiceofhealth.com\/index.php\/2026\/01\/15\/real-world-answers-for-patients-running-out-of-time\/","title":{"rendered":"Real-world answers for patients running out of time"},"content":{"rendered":"
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\n\t\t\tHealth\t\t<\/a><\/p>\n

\n\t\tReal-world answers for patients up against the clock\t<\/h1>\n<\/p><\/div>\n
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\n\t\tJacob Sweet\t<\/p>\n

\n\t\t\tHarvard Staff Writer\t\t<\/p>\n<\/p><\/address>\n<\/p><\/div>\n

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\n\t\t\t5 min read\t\t<\/span>\n\t<\/div>\n

\n\t\t\tInsurance data can help fill gaps between longer trials, researchers say\t\t<\/h2>\n<\/header>\n
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Randomized clinical trials remain the gold standard for establishing a medication\u2019s effects, producing the evidence by which most drugs and interventions in the U.S. are approved.<\/p>\n

But these studies typically require large numbers of patients, huge amounts of data, and thorough follow-ups, none of which comes easy or free. The upshot is fewer investigations into scenarios that are clinically important but unlikely to yield a profit for the firms funding them. <\/p>\n

Accordingly, researchers have been developing an option that uses real-world data from insurers to save patients from falling through the cracks. <\/p>\n

\u201cThere\u2019s little incentive for pharmaceutical companies to test combinations of treatments, for example, because a manufacturer typically aims to market its own product rather than evaluate it alongside another,\u201d said Sebastian Schneeweiss<\/a>, professor of medicine and epidemiology at Harvard Medical School. In addition, subsets of patients \u2014 such as pregnant women \u2014 are excluded from trials for ethical reasons, leaving gaps in knowledge.<\/p>\n

\u201cThere are very tangible use cases where we would love to have trials, but we\u2019ll never have them, and we need to recognize this,\u201d said Schneeweiss, who also serves as chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women\u2019s Hospital. \u201cAnd at the same time, we\u2019re sitting on this huge pile of longitudinal and patient-level data, of which only a very small proportion is used today to turn into evidence.\u201d <\/p>\n

This untapped data could help answer critical questions \u2014 such as whether a drug approved for diabetes could also prevent heart attacks or whether a treatment tested on middle-aged men works equally well for pregnant women \u2014 much faster than an RCT can.<\/p>\n

For nearly a decade, turning these findings into actionable evidence has been the goal of Schneeweiss and Shirley Wang, associate professor of medicine at Harvard Medical School.<\/p>\n

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Sebastian Schneeweiss (from left), Nils Kr\u00fcger, and Shirley Wang.<\/p>\n

Niles Singer\/Harvard Staff Photographer<\/p>\n<\/figcaption><\/figure>\n

As co-directors of RCT-DUPLICATE (Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology), they have developed methods that use real-world evidence<\/a> (RWE) \u2014 like insurance claims from Medicare and Medicaid collected during routine clinical care \u2014 to determine whether a medicine might be effective beyond a trial\u2019s original indication.<\/p>\n

\u201cWe love RCTs,\u201d said Wang, \u201cbut they can\u2019t answer all questions.\u201d <\/p>\n

To understand when and how RWE studies can complement trials, the team emulates the design of a reference trial as closely as possible using the RCT\u2019s study design. \u201cWe\u2019re trying to predict what those results would be,\u201d said Wang, \u201cand see how close we can get.\u201d<\/p>\n

From there, the team benchmarks their results against the reference RCT. When the emulation closely reproduces the trial\u2019s results, this suggests that the data, design, and analysis infrastructure is robust and researchers may be more confident about expanding the original research question to populations or outcomes the original trial didn\u2019t address. <\/p>\n

Beyond expanding the scope of existing RCTs, the group aims to demonstrate the validity of using data routinely collected in clinical practice to produce meaningful conclusions \u2014 pushing back against those who dismiss the use of real-world evidence.<\/p>\n

\u201cThere\u2019s criticism, of course, that you already know what the results are, so maybe you\u2019re tailoring to get those results,\u201d said Wang.<\/p>\n

To counter this criticism, the team has emulated more than half a dozen trials that had not yet released data, running analyses to see how well their methods could predict unpublished results. The group also publishes their protocols before they run their analyses, allowing people to see their methods and preventing themselves from adjusting analyses to fit an existing result.<\/p>\n

As the core methods have been validated over years of work, the group has put them into practice.<\/p>\n

Building on the RCT-DUPLICATE framework, Nils Kr\u00fcger, an instructor at Harvard Medical School and Brigham and Women\u2019s Hospital, showed in two recent studies that GLP-1 drugs like semaglutide and tirzepatide yield cardiovascular benefits beyond their FDA parameters.<\/p>\n

While the drugs are generally approved to treat obesity and Type 2 diabetes, Kr\u00fcger\u2019s analyses showed that the drugs lowered the risk of hospitalization for heart failure<\/a> or all-cause mortality by 40 percent compared with a placebo proxy. <\/p>\n

The study has since informed the World Health Organization\u2019s international guideline on the use and indications of GLP-1 medicines in obesity and was recently recognized among the American Medical Association\u2019s \u201cResearch of the Year\u201d selections for 2025.<\/p>\n

In another study released last month, Kr\u00fcger showed that tirzepatide and semaglutide provide comparable cardiovascular<\/a> benefits to one another, refuting conflicting presentations from their parent companies that claimed superior results for one or the other.<\/p>\n

Kr\u00fcger hopes that the study will help clinicians better understand how these medications perform in the broader, more diverse patient populations routinely seen in everyday practice.<\/p>\n

Besides identifying new indications, Wang hopes these studies can support clinical decision-making and justify reimbursement from Health Technology Assessments (HTAs) and payers who require compelling evidence before covering an intervention. The approvals could help more people access effective treatments sooner.<\/p>\n

She pointed to DOACs \u2014 direct oral anticoagulants with better effectiveness and fewer side effects than older blood thinners. With each new indication, DOACs improved treatment for people suffering from conditions like atrial fibrillation and deep vein thrombosis. Yet reaching the broad range of approvals they hold today took more than a decade.<\/p>\n

With emerging anticoagulants such as Factor XI inhibitors \u2014 which could further reduce bleeding risk while preventing blood clots, Wang wonders whether it is necessary to wait that long again.<\/p>\n

\u201cDo we wait 15 years for more trials to be completed, or can we get more expedited evidence that is well grounded?\u201d she asked. \u201cThat\u2019s an open question, so we\u2019ll see what the FDA says and work with them to explore how real-world evidence can complement RCTs.\u201d <\/p>\n

For Wang, Schneeweiss, and Kr\u00fcger \u2014 and the team of researchers behind RCT-DUPLICATE \u2014 the point is to save more lives today, with data that already exists.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"

Health Real-world answers for patients up against the clock Jacob Sweet Harvard Staff Writer January 7, 2026 5 min read Insurance data can help fill gaps between longer trials, researchers say Randomized clinical trials remain the gold standard for establishing a medication\u2019s effects, producing the evidence by which most drugs and interventions in the U.S. …<\/p>\n","protected":false},"author":1,"featured_media":2885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"loftocean_post_primary_category":0,"loftocean_post_format_gallery":"","loftocean_post_format_gallery_ids":"","loftocean_post_format_gallery_urls":"","loftocean_post_format_video_id":0,"loftocean_post_format_video_url":"","loftocean_post_format_video_type":"","loftocean_post_format_video":"","loftocean_post_format_audio_type":"","loftocean_post_format_audio_url":"","loftocean_post_format_audio_id":0,"loftocean_post_format_audio":"","loftocean-featured-post":"","loftocean-like-count":0,"loftocean-view-count":131,"tinysalt_single_post_intro_label":"","tinysalt_single_post_intro_description":"","tinysalt_hide_post_featured_image":"","tinysalt_post_featured_media_position":"","tinysalt_single_site_header_source":"","tinysalt_single_custom_site_header":"0","tinysalt_single_custom_sticky_site_header":"0","tinysalt_single_custom_sticky_site_header_style":"sticky-scroll-up","tinysalt_single_site_footer_source":"","tinysalt_single_custom_site_footer":"0","footnotes":""},"categories":[37],"tags":[],"class_list":["post-2884","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-staying-healthy"],"_links":{"self":[{"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/posts\/2884","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/comments?post=2884"}],"version-history":[{"count":0,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/posts\/2884\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/media\/2885"}],"wp:attachment":[{"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/media?parent=2884"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/categories?post=2884"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/americanvoiceofhealth.com\/index.php\/wp-json\/wp\/v2\/tags?post=2884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}