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<div class="meta-article-type thm-col">Special Communication </div>
<div class="meta-super-class">Integrating Clinical Trials and Practice</div>
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<div class="meta-date"><span class="epreprint"><span class="month">August </span><span class="day">5, </span><span class="year">2024</span></span></div>
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<h1 class="meta-article-title ">Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence</h1>
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<div class="meta-authors">
<span class="meta-authors--limited"><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Joseph+B.+Franklin&q=Joseph+B.+Franklin" rel="nofollow" target="_blank">Joseph B. Franklin, JD, PhD<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Caroline+Marra&q=Caroline+Marra" rel="nofollow" target="_blank">Caroline Marra, PhD<sup>1</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Kaleab+Z.+Abebe&q=Kaleab+Z.+Abebe" rel="nofollow" target="_blank">Kaleab Z. Abebe, PhD<sup>2</sup></a></span>;
<a class="meta-authors--etal td-u stats-meta-authors--etal">et al</a></span>
<span class="meta-authors--remaining"><span class="wi-fullname brand-fg"><a href="/searchresults?author=Atul+J.+Butte&q=Atul+J.+Butte" rel="nofollow" target="_blank">Atul J. Butte, MD, PhD<sup>3,4</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Deborah+J.+Cook&q=Deborah+J.+Cook" rel="nofollow" target="_blank">Deborah J. Cook, MD<sup>5</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Laura+Esserman&q=Laura+Esserman" rel="nofollow" target="_blank">Laura Esserman, MD, MBA<sup>6</sup></a></span><span
class="al-author-delim">; </span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Lee+A.+Fleisher&q=Lee+A.+Fleisher" rel="nofollow" target="_blank">Lee A. Fleisher, MD<sup>7</sup></a></span><span
class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Cynthia+I.+Grossman&q=Cynthia+I.+Grossman" rel="nofollow" target="_blank">Cynthia I. Grossman, PhD<sup>8</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Nancy+E.+Kass&q=Nancy+E.+Kass" rel="nofollow" target="_blank">Nancy E. Kass, ScD<sup>9</sup></a></span><span class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Harlan+M.+Krumholtz&q=Harlan+M.+Krumholtz" rel="nofollow" target="_blank">Harlan M. Krumholtz, MD, SM<sup>10</sup></a></span><span class="al-author-delim">;
</span><span class="wi-fullname brand-fg"><a href="/searchresults?author=Kathy+Rowan&q=Kathy+Rowan" rel="nofollow" target="_blank">Kathy Rowan, PhD<sup>11,12</sup></a></span><span class="al-author-delim">; </span><span
class="wi-fullname brand-fg"><a href="/searchresults?author=Amy+P.+Abernethy&q=Amy+P.+Abernethy" rel="nofollow" target="_blank">Amy P. Abernethy, MD, PhD<sup>13</sup></a></span><span class="al-author-delim">; </span>for
the JAMA Summit on Clinical Trials Participants<sup></sup></span>
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<div class="meta-author">
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<div class="meta-author-name"><sup>1</sup>Verily Life Sciences, South San Francisco, California</div>
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<div class="meta-author-name"><sup>2</sup>Center for Biostatistics & Qualitative Methodology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania</div>
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<div class="meta-author-name"><sup>3</sup>Bakar Computational Health Sciences Institute, University of California, San Francisco</div>
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<div class="meta-author-name"><sup>4</sup>Center for Data-Driven Insights and Innovation, University of California Health, Oakland</div>
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<div class="meta-author-name"><sup>5</sup>Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada</div>
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<div class="meta-author-name"><sup>6</sup>Departments of Surgery and Radiology and Institute for Health Policy Studies, University of California, San Francisco</div>
</li>
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<div class="meta-author-name"><sup>7</sup>Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia</div>
</li>
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<div class="meta-author-name"><sup>8</sup>Biogen, Boston, Massachusetts</div>
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<div class="meta-author-name"><sup>9</sup>Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland</div>
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<div class="meta-author-name"><sup>10</sup>Yale University School of Medicine, New Haven, Connecticut</div>
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<div class="meta-author-name"><sup>11</sup>National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Programme, London, United Kingdom</div>
</li>
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<div class="meta-author-name"><sup>12</sup>Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom</div>
</li>
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<div class="meta-author-name"><sup>13</sup>Highlander Health, Dallas, Texas</div>
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<span class="meta-citation-journal-name">JAMA. </span><span class="meta-citation"> Published online August 5, 2024. doi:10.1001/jama.2024.0268</span>
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<p><strong>Importance</strong> <span>The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of
evidence that can be generated.</span></p>
<p><strong>Observations</strong> <span>Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of
evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions,
payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted
in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure.</span></p>
<p><strong>Conclusions and Relevance</strong> <span>We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources
and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal.</span></p>
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[Skip to Navigation] Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors JOURNALS JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) PODCASTS Clinical Reviews Editors' Summary Medical News Author Interviews More JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2024 American Medical Association. All Rights Reserved Search All * Search All * JAMA * JAMA Network Open * JAMA Cardiology * JAMA Dermatology * JAMA Forum Archive * JAMA Health Forum * JAMA Internal Medicine * JAMA Neurology * JAMA Oncology * JAMA Ophthalmology * JAMA Otolaryngology–Head & Neck Surgery * JAMA Pediatrics * JAMA Psychiatry * JAMA Surgery * Archives of Neurology & Psychiatry Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal TRENDING * Labor Unionization Among US Health Care Workers Research December 27, 2022 * Integrating Clinical Trials and Practice Opinion June 3, 2024 X Facebook LinkedIn More New Online Views 5,319 Citations 0 24 View Metrics * Download PDF * Full Text * CME & MOC * Share X Facebook Email LinkedIn * Cite This * Permissions Special Communication Integrating Clinical Trials and Practice August 5, 2024 MODERNIZING THE DATA INFRASTRUCTURE FOR CLINICAL RESEARCH TO MEET EVOLVING DEMANDS FOR EVIDENCE Joseph B. Franklin, JD, PhD1; Caroline Marra, PhD1; Kaleab Z. Abebe, PhD2; et al Atul J. Butte, MD, PhD3,4; Deborah J. Cook, MD5; Laura Esserman, MD, MBA6; Lee A. Fleisher, MD7; Cynthia I. Grossman, PhD8; Nancy E. Kass, ScD9; Harlan M. Krumholtz, MD, SM10; Kathy Rowan, PhD11,12; Amy P. Abernethy, MD, PhD13; for the JAMA Summit on Clinical Trials Participants Author Affiliations Article Information * 1Verily Life Sciences, South San Francisco, California * 2Center for Biostatistics & Qualitative Methodology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania * 3Bakar Computational Health Sciences Institute, University of California, San Francisco * 4Center for Data-Driven Insights and Innovation, University of California Health, Oakland * 5Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada * 6Departments of Surgery and Radiology and Institute for Health Policy Studies, University of California, San Francisco * 7Anesthesiology and Critical Care, University of Pennsylvania Perelman School of Medicine, Philadelphia * 8Biogen, Boston, Massachusetts * 9Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland * 10Yale University School of Medicine, New Haven, Connecticut * 11National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research Programme, London, United Kingdom * 12Intensive Care National Audit & Research Centre (ICNARC), London, United Kingdom * 13Highlander Health, Dallas, Texas JAMA. Published online August 5, 2024. doi:10.1001/jama.2024.0268 visual abstract icon Visual Abstract editorial comment icon Editorial Comment related articles icon Related Articles author interview icon Interviews multimedia icon Multimedia audio icon Listen to this article Video (25:06) Envisioning a Path Forward for Clinical Trials—JAMA Summit Keynote Presentation by Amy P. Abernethy, MD, PhD Full Text Abstract Importance The ways in which we access, acquire, and use data in clinical trials have evolved very little over time, resulting in a fragmented and inefficient system that limits the amount and quality of evidence that can be generated. Observations Clinical trial design has advanced steadily over several decades. Yet the infrastructure for clinical trial data collection remains expensive and labor intensive and limits the amount of evidence that can be collected to inform whether and how interventions work for different patient populations. Meanwhile, there is increasing demand for evidence from randomized clinical trials to inform regulatory decisions, payment decisions, and clinical care. Although substantial public and industry investment in advancing electronic health record interoperability, data standardization, and the technology systems used for data capture have resulted in significant progress on various aspects of data generation, there is now a need to combine the results of these efforts and apply them more directly to the clinical trial data infrastructure. Conclusions and Relevance We describe a vision for a modernized infrastructure that is centered around 2 related concepts. First, allowing the collection and rigorous evaluation of multiple data sources and types and, second, enabling the possibility to reuse health data for multiple purposes. We address the need for multidisciplinary collaboration and suggest ways to measure progress toward this goal. Full Text Access through your institution Add or change institution READ MORE ABOUT Research, Methods, Statistics Ophthalmology Neonatology Pediatrics Reproductive Health Download PDF Full Text Cite This CITATION Franklin JB, Marra C, Abebe KZ, et al. Modernizing the Data Infrastructure for Clinical Research to Meet Evolving Demands for Evidence. JAMA. Published online August 05, 2024. doi:10.1001/jama.2024.0268 MANAGE CITATIONS: Ris (Zotero) EndNote BibTex Medlars ProCite RefWorks Reference Manager Mendeley © 2024 Permissions CME & MOC Access through your institution Add or change institution How Can Operating Rooms Be Greener? Video Player is loading. 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