{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T14:24:08Z","timestamp":1787408648431,"version":"build-2736575974"},"reference-count":79,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T00:00:00Z","timestamp":1785888000000},"content-version":"vor","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Evaluating the benefit\u2013risk profile of a medical product requires comprehensive evidence that integrates information across development stages. Technological advances and broader use of real\u2010world data are enabling innovative quantitative paradigms characterized by greater efficiency, patient centricity, and sustainability. Despite regulatory recognition of model\u2010informed drug development, disease progression modeling (DPM) remains underutilized compared with more established pharmacokinetic\/pharmacodynamic modeling and simulation approaches. To inform adoption decisions by clinical, regulatory, and portfolio leaders, the Clinical Trials Transformation Initiative (CTTI) developed evidence\u2010based, cross\u2010sector recommendations that describe when and how to use DPM in medical product development and how to effectively communicate its impactful implementation across functions. In this article, we (i) define DPM and summarize its unique value in clinical development, (ii) describe CTTI's collaborative process to generate a set of nine DPM recommendations and a practical considerations framework, and (iii) present examples of strategic development questions showing how DPM can answer high\u2010value questions about indication, population, endpoints, and dose selection. By providing a shared vocabulary and structured questions for decision makers and modelers, these recommendations may lower barriers to DPM implementation, support fit\u2010for\u2010purpose use of existing and new models, and enable more efficient, patient\u2010focused, and sustainable clinical development.<\/jats:p>","DOI":"10.1111\/cts.70686","type":"journal-article","created":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T13:46:27Z","timestamp":1785937587000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Empowering Clinical Development With Disease Progression Modeling: Recommendations From the Clinical Trials Transformation Initiative"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5434-443X","authenticated-orcid":false,"given":"Lindsay S.","family":"Kehoe","sequence":"first","affiliation":[{"name":"The Clinical Trials Transformation Initiative Duke Clinical Research Institute  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-0343-1861","authenticated-orcid":false,"given":"Shu Chin","family":"Ma","sequence":"additional","affiliation":[{"name":"Model\u2010Informed Drug Development and Quantitative Medicine Critical Path Institute  Tucson Arizona USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5755-3904","authenticated-orcid":false,"given":"Jiang","family":"Liu","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4053-4213","authenticated-orcid":false,"given":"Qi","family":"Liu","sequence":"additional","affiliation":[{"name":"Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration  Silver Spring Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7896-6716","authenticated-orcid":false,"given":"Herbert","family":"Pang","sequence":"additional","affiliation":[{"name":"PD Data Science &amp; Analytics Genentech  South San Francisco California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6081-7897","authenticated-orcid":false,"given":"Bruce","family":"Burnett","sequence":"additional","affiliation":[{"name":"Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases National Institutes of Health  Bethesda Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5439-1607","authenticated-orcid":false,"given":"Reem","family":"Yunis","sequence":"additional","affiliation":[{"name":"RAYS Partners Consulting  Menlo Park California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4039-9813","authenticated-orcid":false,"given":"Karthik","family":"Venkatakrishnan","sequence":"additional","affiliation":[{"name":"EMD Serono Research and Development Institute, Inc.  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