{"id":10101,"date":"2025-07-08T12:54:12","date_gmt":"2025-07-08T12:54:12","guid":{"rendered":"https:\/\/main-portal.develop-mytomorrows.com\/?p=10101"},"modified":"2025-07-08T14:51:52","modified_gmt":"2025-07-08T14:51:52","slug":"test-unlocking-the-potential-of-real-world-evidence-derived-from-expanded-access-programs","status":"publish","type":"post","link":"https:\/\/main-portal.develop-mytomorrows.com\/ar\/blog\/real-world-data\/test-unlocking-the-potential-of-real-world-evidence-derived-from-expanded-access-programs\/","title":{"rendered":"(Test) Unlocking the potential of Real-World Evidence derived from Expanded Access Programs"},"content":{"rendered":"<div>\n<h4>Table of Contents<\/h4>\n<ul>\n<li><a href=\"#section1\">Expanded Access Programs: A Path to Harnessing Real-World Data<\/a><\/li>\n<li><a href=\"#section2\">Exploring the Use of Real-World Data from EAPs: Our Research Findings<\/a><\/li>\n<li><a href=\"#section3\">Keys to Success in Real-World Data Collection from EAPs<\/a><\/li>\n<\/ul>\n<\/div>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p><b><i><span data-contrast=\"auto\">By Jasmin Schelhaas, Real-World Data Associate at myTomorrows<\/span><\/i><\/b><\/p>\n<h3><span data-contrast=\"none\">Expanded Access Programs: A Path to Harnessing Real-World Data\u202f<\/span><span data-ccp-props=\"{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":40,\"335559739\":0,\"335559740\":259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"auto\">Expanded access programs (EAPs) provide an important avenue for patients with debilitating and\/or life-threatening conditions, who have no alternative treatment options and are unable or ineligible to enroll in clinical trials to access pre-approval options. While the primary intent of EAPs is to provide access to treatment, there has also been a growing interest in collecting and analyzing Real-World Data (RWD) from these programs. This growing interest is primarily due to the increasing appreciation for Real-World Evidence (RWE) reflected in greater integration by health authorities into their regulatory guidelines, and the broader use of this evidence in scientific publications, regulatory submissions, and cost reimbursement decisions<sup>1-5<\/sup><\/span><span data-contrast=\"auto\">.<\/span> <span data-contrast=\"auto\">Especially for rare diseases, gathering additional data through EAPs can be essential as each patient\u2019s information is valuable<\/span><span data-contrast=\"auto\"><sup>6<\/sup><\/span><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{\"134233117\":true,\"134233118\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":0,\"335559740\":240}\">\u00a0<a id=\"section2\"><\/a><\/span><br \/>\n<span data-contrast=\"auto\">In this blog, we will highlight key findings of research on collecting RWD within EAPs. Furthermore, we will emphasize some key elements for successful data outputs based on practical insights from our experiences.<\/span><span data-contrast=\"none\">\u202f<\/span><span data-ccp-props=\"{\"134233117\":false,\"134233118\":false,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<h3 aria-level=\"2\"><span data-contrast=\"none\">Exploring the Use of Real-World Data from EAPs: Our Research Findings<\/span><span data-ccp-props=\"{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":40,\"335559739\":0,\"335559740\":259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">To support BioPharma companies in utilizing RWD from EAPs, research has been conducted to explore the practical applications of this data.<\/span><span data-ccp-props=\"{\"134233117\":false,\"134233118\":false,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">myTomorrows\u2019 in-house RWD team published several articles on gathering RWD from EAPs in collaboration with <\/span><span data-contrast=\"auto\">interns and academics. In our latest research, we investigated the extent to which data from EAPs were published in academic literature. The results of this research, entitled \u2018Results from expanded access programs: a review of academic literature\u2019 show that there is a significant increase in the number of publications over time<\/span><span data-contrast=\"auto\"><sup>2<\/sup><\/span><span data-contrast=\"auto\">, which could reflect a general increase in attention for RWD derived from EAPs.\u00a0<\/span><span data-ccp-props=\"{\"134233117\":false,\"134233118\":false,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">But that\u2019s not all. In other studies, we encountered that, over time, RWD and RWE derived from EAPs are also more often used by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to inform safety and efficacy labels for new treatments<\/span><span data-contrast=\"auto\"><sup>3<\/sup><\/span><span data-contrast=\"auto\">. Health technology assessment (HTA) bodies such as the National Institute for Health and Care Excellence (NICE) also incorporate data from EAPs to determine the cost-effectiveness of new treatments<\/span><span data-contrast=\"auto\"><sup>4<\/sup><\/span><span data-contrast=\"auto\">. For NICE, EAP data was even used in over one in five appraisals. Various real-case examples, such as FDA approvals for drugs like Vijoice (alpelisib), Zolgensma (onasemnogene abeparvovec) and Luthathera (lutetium (177Lu)) further underscore<\/span><span data-contrast=\"none\"> t<\/span><span data-contrast=\"auto\">he use of EAP data in regulatory decision making<\/span><span data-contrast=\"auto\"><sup>7-9<\/sup><\/span><span data-contrast=\"auto\">.<\/span><a id=\"section3\"><\/a><\/p>\n<p>\u00a0<\/p>\n<div style=\"max-width: 800px; margin: 40px auto; padding: 40px; background-color: #f2f2f2; border-radius: 12px;\">\n<p style=\"margin: 0 0 16px; font-size: 20px; font-weight: 500; line-height: 1.5; color: #036240;\">\nAbout the author<\/p>\n<h2 style=\"margin: 0; font-size: 20px; font-weight: 500; line-height: 1.5;\">Andrea Enguita Marruedo, PhD \u2013 Expert Medical Writer<\/h2>\n<p style=\"margin: 4px 0 24px; font-size: 16px; font-weight: 300; line-height: 1.5; color: #666666;\">Medical Content Writer at myTomorrows<\/p>\n<p style=\"margin: 0 0 20px; font-size: 16px; font-weight: 300; line-height: 1.5;\">Dr. Andrea Enguita Marruedo holds a master\u2019s in Genetics and Cell Biology from the Autonomous University of Madrid and a PhD in Developmental Biology from the Erasmus Medical Centre in Rotterdam. She began her career in medical writing after completing her doctoral studies and has covered a wide range of therapeutic areas, including neuromuscular and neurodegenerative disorders, cancer, and diabetes.<\/p>\n<p style=\"margin: 0; font-size: 16px; font-weight: 300; line-height: 1.5;\">Andrea specializes in translating complex biomedical topics into clear, accessible content for patients and healthcare professionals. With a strong research background and a passion for science communication, she is committed to delivering accurate, well-referenced content that supports greater awareness and understanding of medical topics among patients, caregivers, and clinicians.<\/p>\n<\/div>\n<h3 aria-level=\"3\"><span data-contrast=\"none\">Effective Study Design<\/span><span data-ccp-props=\"{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":40,\"335559739\":0,\"335559740\":259}\">\u00a0<\/span><\/h3>\n<ul>\n<li data-leveltext=\"-\" data-font=\"Calibri\" data-listid=\"5\" data-list-defn-props=\"{\"335551671\":6,\"335552541\":1,\"335559685\":360,\"335559991\":360,\"469769226\":\"Calibri\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"-\",\"469777815\":\"hybridMultilevel\"}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">When initiating an EAP, it\u2019s important to plan ahead and identify potential <\/span>RWD needs early on. Consider why you want to collect data and how you want to collect it. Whether it\u2019s for supporting regulatory submission, gathering data on specific subgroups, or identifying rare safety events, each objective requires a different strategy.<\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"-\" data-font=\"Calibri\" data-listid=\"5\" data-list-defn-props=\"{\"335551671\":6,\"335552541\":1,\"335559685\":360,\"335559991\":360,\"469769226\":\"Calibri\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"-\",\"469777815\":\"hybridMultilevel\"}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\">To minimize the burden on physicians and ensure high data uptake, we recommend focusing solely on key\/critical data points. If you integrate these key data points into the same system used for completing the EAP enrolment requests and placing the re-orders\u00b9, you will even enhance efficiency as physicians are already familiar with the system.<\/li>\n<li data-leveltext=\"-\" data-font=\"Calibri\" data-listid=\"5\" data-list-defn-props=\"{\"335551671\":6,\"335552541\":1,\"335559685\":360,\"335559991\":360,\"469769226\":\"Calibri\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"-\",\"469777815\":\"hybridMultilevel\"}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\">Choose an easy-to-use, user-friendly Electronic Data Capturing (EDC) system, meaning it has an intuitive interface, customizable forms, and easy integration with existing workflows. A streamlined, physician-centric workflow that integrates all elements of the EAP within a single system would be optimal.<\/li>\n<li data-leveltext=\"-\" data-font=\"Calibri\" data-listid=\"5\" data-list-defn-props=\"{\"335551671\":6,\"335552541\":1,\"335559685\":360,\"335559991\":360,\"469769226\":\"Calibri\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"-\",\"469777815\":\"hybridMultilevel\"}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\">Use queries, automated data validations, and source data verification to maximize the quality of the data and ensure this is all well captured in data management Standard Operating Procedures (SOPs) & a data management plan.<\/li>\n<li data-leveltext=\"-\" data-font=\"Calibri\" data-listid=\"5\" data-list-defn-props=\"{\"335551671\":6,\"335552541\":1,\"335559685\":360,\"335559991\":360,\"469769226\":\"Calibri\",\"469769242\":[8226],\"469777803\":\"left\",\"469777804\":\"-\",\"469777815\":\"hybridMultilevel\"}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\">Make sure to proactively communicate with health authorities in the countries where you want to collect data. Since each country may have its own rules and regulations, it\u2019s important to understand what\u2019s possible and what\u2019s not before you start collecting.<\/li>\n<\/ul>\n<p>\u00a0<\/p>\n<div style=\"background-color: #1e4d37; color: #ffffff; padding: 32px; border-radius: 20px; text-align: center; max-width: 900px; margin: auto;\">\n<h3 style=\"margin: 0 0 10px 0; color: #ffffff;\">How can we <b>help?<\/b><\/h3>\n<p style=\"margin: 0 0 30px 0; font-size: 16px; color: #ffffff; line-height: 1.6; max-width: 95%; margin-left: auto; margin-right: auto;\">Lorem ipsum dolor sit amet, consectetur adipiscing elit. Etiam quis nisi quis turpis tristique cursus vitae in ante. Proin ornare risus sit amet auctor malesuada. Curabitur tristique augue ut nulla aliquam facilisis. Curabitur vitae volutpat lacus.<\/p>\n<p style=\"margin-bottom: 0;\"><a style=\"display: inline-block; background-color: #4a8c6f; color: #ffffff; font-size: 16px; padding: 12px 24px; border-radius: 25px; text-decoration: none; font-weight: 400;\" href=\"#\">Contact our team<\/a><\/p>\n<\/div>\n<p>\u00a0<\/p>\n<h3 aria-level=\"3\">Successful Study Execution<\/h3>\n<p>Other key success factors in ensuring complete, high-quality data in the EDC system, are site support, remote monitoring and using queries.\u00a0 To ensure support at each key milestone within the EAP, physicians should be guided through the whole EAP application process by experienced personnel. Offer clear instructions from the start, especially for the research na\u00efve sites, and have a RWD expert dedicated to managing the data collection within the EAP. Successful remote monitoring involves enabling automatic notifications via email, raising queries in the EDC system to seek further explanation or address any missing information and being available online for assistance with the EDC system whenever needed.<\/p>\n<h3 aria-level=\"3\"><span data-contrast=\"none\">Optimizing Data Analysis & Output<\/span><span data-ccp-props=\"{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559738\":40,\"335559739\":0,\"335559740\":259}\">\u00a0<\/span><\/h3>\n<p>Before analyzing the data and producing an output it is crucial to write a statistical analysis plan (SAP) outlining how the analysis will be performed. This plan should clearly define which patients and which data will be included, how it will be analyzed, and what statistical methods will be applied. If you plan to use the data for regulatory submission, it\u2019s important to engage with health authorities and regulators early as well. The FDA recommends engaging with them via a regulatory pathway (e.g., by requesting a Type C meeting) if including RWD, to identify challenges in the design and planning and to discuss how these challenges might be addressed. Ideally, the protocol and SAP should also be finalized and shared with the FDA prior to conducting the analyses<sup>11<sup>.\u00a0<\/sup><\/sup><\/p>\n<h3 aria-level=\"2\"><span data-contrast=\"none\">Partnering with myTomorrows for Real-World Data Success\u202f<\/span><span data-ccp-props=\"{\"134245418\":true,\"134245529\":true,\"201341983\":0,\"335559738\":40,\"335559739\":0,\"335559740\":259}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">Taking these learnings from both research and practical experience, <\/span><span data-contrast=\"none\">our dedicated RWD team <\/span><span data-contrast=\"none\">is a front-runner in gathering RWD within an expanded access setting. We offer an integrated approach in RWD strategy, collection, and analysis of data in non-interventional settings and have experience with gathering data for internal use to collect additional safety data, creating tailored outputs for scientific journals and conferences, and assisting with official submissions to regulators.<\/span><span data-ccp-props=\"{\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":160,\"335559740\":259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">If you would like to learn more about how our team of specialists can potentially assist or advise your company with setting up EAPs and\/or RWD collection, we welcome you to reach out and speak with our experts:<\/span> <a href=\"https:\/\/main-portal.develop-mytomorrows.com\/ar\/contact-biopharma\/\"><span data-contrast=\"none\">https:\/\/main-portal.develop-mytomorrows.com\/contact-biopharma\/<\/span><\/a><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":160,\"335559740\":259}\">\u00a0<\/span><\/p>\n<div style=\"display: flex; overflow-x: auto; gap: 10px;\"><a href=\"https:\/\/mytomorrows.com\/\"><img decoding=\"async\" style=\"width: 300px; height: auto;\" src=\"https:\/\/mytomorrows.com\/wp-content\/uploads\/2024\/11\/BioPharma_Pages.png\" alt=\"Image 1\" \/><\/a><br \/>\n<img decoding=\"async\" style=\"width: 300px; height: auto;\" src=\"https:\/\/mytomorrows.com\/wp-content\/uploads\/2024\/11\/On-site_screening.png\" alt=\"Image 2\" \/><br \/>\n<img decoding=\"async\" style=\"width: 300px; height: auto;\" src=\"https:\/\/mytomorrows.com\/wp-content\/uploads\/2024\/11\/Enrollment.png\" alt=\"Image 3\" \/><br \/>\n<img decoding=\"async\" style=\"width: 300px; height: auto;\" src=\"https:\/\/mytomorrows.com\/wp-content\/uploads\/2024\/11\/Chat_Referral.png\" alt=\"Image 3\" \/><\/div>\n<p>\u00a0<\/p>\n<p><span data-ccp-props=\"{\"201341983\":0,\"335551550\":6,\"335551620\":6,\"335559739\":160,\"335559740\":259}\">\u00a0<\/span><\/p>\n<details>\n<summary><strong>References\u00a0<\/strong><\/summary>\n<ol>\n<li><span data-contrast=\"auto\"> Sarp S, Reichenbach R, & Aliu P. An approach to data collection in compassionate use\/managed access. Front Pharmacol.<\/span> <span data-contrast=\"auto\">2022;13:1095860. <\/span><a href=\"https:\/\/doi.org\/10.3389\/fphar.2022.1095860\"><span data-contrast=\"none\">https:\/\/doi.org\/10.3389\/fphar.2022.1095860<\/span><\/a><\/li>\n<li><span data-contrast=\"auto\">2. Polak TB, Cucchi DG, Schelhaas J, Ahmed SS, Khoshnaw N, van Rosmalen J, et al. <\/span><span data-contrast=\"auto\">Results from Expanded Access Programs: A Review of Academic Literature. <\/span><span data-contrast=\"auto\">Drugs.<\/span> <span data-contrast=\"auto\">2023;83(9):795\u2013805. <\/span><a href=\"https:\/\/doi.org\/10.1007\/s40265-023-01879-4\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1007\/s40265-023-01879-4<\/span><\/a><\/li>\n<li><span data-contrast=\"none\">Polak TB, van Rosmalen J, Uyl-de Groot CA. <\/span><span data-contrast=\"none\">Expanded Access as a source of real-world data: an overview of FDA and EMA approvals.\u202f<\/span><span data-contrast=\"none\">Br J Clin Pharmacol. 2020;86(9):1819\u20131826. <\/span><a href=\"https:\/\/doi.org\/10.1111\/bcp.14284\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1111\/bcp.14284<\/span><\/a><\/li>\n<li><span data-contrast=\"none\">Polak TB, Cucchi DG, van Rosmalen J, Uyl-de Groot CA. <\/span><span data-contrast=\"none\">Real-world data from expanded access programmes in health technology assessments: a review of NICE technology appraisals.\u202f<\/span><span data-contrast=\"none\">BMJ Open. 2022;12(1): e052186. <\/span><a href=\"https:\/\/doi.org\/10.1136\/bmjopen-2021-052186\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1136\/bmjopen-2021-052186<\/span><\/a><\/li>\n<li><span data-contrast=\"none\"> Wasser JS, Greenblatt DJ. Applying real-world data from expanded-access (\u201ccompassionate use\u201d) patients to drug development.\u202f<\/span><span data-contrast=\"none\">J Clin Transl Sci. <\/span><span data-contrast=\"none\">2023;7(1): e181. <\/span><a href=\"https:\/\/doi.org\/10.1017\/cts.2023.606\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1017\/cts.2023.606<\/span><\/a><\/li>\n<li><span data-contrast=\"none\"> Wu J, Yang Y, Yu J, Qiao L, Zuo W, Zhang B. Efficacy and safety of compassionate use for rare diseases: a scoping review from 1991 to 2022.\u202fOrphanet J Rare Dis. 2023;18(1):368. <\/span><a href=\"https:\/\/doi.org\/10.1186\/s13023-023-02978-x\"><span data-contrast=\"none\">https:\/\/doi.org\/10.1186\/s13023-023-02978-x<\/span><\/a><\/li>\n<li><span data-contrast=\"none\">U.S. Food and Drug Administration [FDA]. <\/span><span data-contrast=\"auto\">FDA approves alpelisib for PIK3CA-related overgrowth spectrum. <\/span><span data-contrast=\"none\">2022, April 6 <\/span><span data-contrast=\"none\">[cited 2024 Mar 11]. <\/span><span data-contrast=\"auto\">Available from: <\/span><a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-alpelisib-pik3ca-related-overgrowth-spectrum\"><span data-contrast=\"none\">https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-alpelisib-pik3ca-related-overgrowth-spectrum<\/span><\/a><\/li>\n<li><span data-contrast=\"none\"> Aetion. CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi). [Internet]. 2020, April 21 <\/span><span data-contrast=\"none\">[cited 2024 Mar 11]<\/span><i><span data-contrast=\"none\">.<\/span><\/i><span data-contrast=\"none\"> Available from: <\/span><a href=\"https:\/\/aetion.com\/evidence-hub\/fda-decision-alerts\/cder-approved-bla-for-zolgensma-onasemnogene-abeparvovec-xioi\/\"><span data-contrast=\"none\">https:\/\/aetion.com\/evidence-hub\/fda-decision-alerts\/cder-approved-bla-for-zolgensma-onasemnogene-abeparvovec-xioi\/<\/span><\/a><\/li>\n<li><span data-contrast=\"auto\"> Aetion. <\/span><span data-contrast=\"none\">CDER-Approved NDA for LUTATHERA\u00ae (lutetium Lu 177 dotatate). [Internet].<\/span> <span data-contrast=\"auto\">2020, April 20 <\/span><span data-contrast=\"none\">[cited 2024 Mar 11].<\/span> <span data-contrast=\"none\">Available from<\/span><i><span data-contrast=\"none\">:<\/span><\/i> <a href=\"https:\/\/aetion.com\/evidence-hub\/fda-decision-alerts\/cder-approved-nda-for-lutathera-r-lutetium-lu-177-dotatate\/\"><span data-contrast=\"none\">https:\/\/aetion.com\/evidence-hub\/fda-decision-alerts\/cder-approved-nda-for-lutathera-r-lutetium-lu-177-dotatate\/<\/span><\/a><\/li>\n<li><span data-contrast=\"none\">U.S. Food and Drug Administration [FDA]. <\/span><span data-contrast=\"auto\">Demonstrating substantial evidence of effectiveness with one adequate and well-controlled clinical investigation and confirmatory evidence \u2013 Guidance for Industry. Sep 2023 (draft guidance). III-G Types of Confirmatory Evidence \u2013 Evidence from Expanded Access Use of an Investigational Drug. [Internet]<\/span><b><span data-contrast=\"auto\">. <\/span><\/b><span data-contrast=\"auto\">2023 <\/span><span data-contrast=\"none\">[cited 2024 Mar 13]<\/span><span data-contrast=\"none\">. <\/span><span data-contrast=\"auto\">Available from:\u202f<\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/demonstrating-substantial-evidence-effectiveness-one-adequate-and-well-controlled-clinical\"><span data-contrast=\"none\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/demonstrating-substantial-evidence-effectiveness-one-adequate-and-well-controlled-clinical<\/span><\/a><\/li>\n<li><span data-contrast=\"none\">U.S. Food and Drug Administration [FDA]. Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products: Guidance for Industry.[Internet]. 2023 <\/span><span data-contrast=\"none\">[cited 2024 Mar 13]<\/span><span data-contrast=\"none\">.<\/span> <span data-contrast=\"none\">Available from: <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug\"><span data-contrast=\"none\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug<\/span><\/a><\/li>\n<\/ol>\n<\/details>\n","protected":false},"excerpt":{"rendered":"<p>Table of Contents Expanded Access Programs: A Path to Harnessing Real-World Data Exploring the Use of Real-World Data from EAPs: Our Research Findings Keys to Success in Real-World Data Collection from EAPs \u00a0 \u00a0 By Jasmin Schelhaas, Real-World Data Associate at myTomorrows Expanded Access Programs: A Path to Harnessing Real-World Data\u202f\u00a0 Expanded access programs (EAPs) [&hellip;]<\/p>\n","protected":false},"author":16,"featured_media":7088,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[50,180],"tags":[204,205,206,207],"class_list":["post-10101","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biopharma","category-real-world-data","tag-real-world-evidence","tag-analytics","tag-analysis","tag-real-world-data-pharma"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.5 (Yoast SEO v25.3.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>(Test) Unlocking the potential of Real-World Evidence derived from Expanded Access Programs - myTomorrows<\/title>\n<meta name=\"description\" content=\"Expanded Access Programs: A Path to Harnessing Real-World Data\u202f. 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