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Answering the Clinical Research Challenge in a Growing Health System

2019; American College of Physicians; Volume: 171; Issue: 6 Linguagem: Inglês

10.7326/m19-1656

1539-3704

David J. Whellan,

Health Systems, Economic Evaluations, Quality of Life

Ideas and Opinions17 September 2019Answering the Clinical Research Challenge in a Growing Health SystemDavid J. Whellan, MD, MHSDavid J. Whellan, MD, MHSJefferson Clinical Research Institute, Thomas Jefferson University, Philadelphia, Pennsylvania (D.J.W.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-1656 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Clinical research in the United States is under siege. The number of clinical trials, whether measured as the number of trials performed, number of participants enrolled, or number of investigators, is declining sharply (1). Although the United States has the highest proportion of clinical trial sites in the world at 43%, the annual growth rate from 2006 to 2012 was negative (2).Several factors have converged to create an environment within the United States that does not promote clinical trial research (Table). Economic drivers, such as the cost of performing clinical trials, turn sponsors to other countries (3). Reductions in ...References1. Getz K. Number of active investigators in FDA-regulated clinical trials drop. Tufts CSDD Impact Report. 2005;7:1-4. Google Scholar2. Drain PK, Parker RA, Robine M, et al. Global migration of clinical research during the era of trial registration. PLoS One. 2018;13:e0192413. [PMID: 29489839] doi:10.1371/journal.pone.0192413 CrossrefMedlineGoogle Scholar3. Jeong S, Sohn M, Kim JH, et al. Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011-2013. Trials. 2017;18:288. [PMID: 28637515] doi:10.1186/s13063-017-2025-1 CrossrefMedlineGoogle Scholar4. Ehrhardt S, Appel LJ, Meinert CL. Trends in national institutes of health funding for clinical trials registered in ClinicalTrials.gov. JAMA. 2015;314:2566-7. [PMID: 26670975] doi:10.1001/jama.2015.12206 CrossrefMedlineGoogle Scholar5. Kramer JM, Smith PB, Califf RM. Impediments to clinical research in the United States. Clin Pharmacol Ther. 2012;91:535-41. [PMID: 22318614] doi:10.1038/clpt.2011.341 CrossrefMedlineGoogle Scholar6. Meador KJ. Decline of clinical research in academic medical centers. Neurology. 2015;85:1171-6. [PMID: 26156509] doi:10.1212/WNL.0000000000001818 CrossrefMedlineGoogle Scholar7. Daniels RJ. A generation at risk: young investigators and the future of the biomedical workforce. Proc Natl Acad Sci U S A. 2015;112:313-8. [PMID: 25561560] doi:10.1073/pnas.1418761112 CrossrefMedlineGoogle Scholar8. Morris M, Abrams K, Gerhardt W, Laughlin B. Academic Medical Centers. Joining forces with community providers for broad benefits. Deloitte Center for Health Solutions. Accessed at www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/academic-medical-centers-consolidation.html on 28 June 2019. Google Scholar9. Grover A, Slavin PL, Willson P. The economics of academic medical centers. N Engl J Med. 2014;370:2360-2. [PMID: 24826948] doi:10.1056/NEJMp1403609 CrossrefMedlineGoogle Scholar10. Christensen MC, Remler D. Information and communications technology in U.S. health care: why is adoption so slow and is slower better?. J Health Polit Policy Law. 2009;34:1011-34. [PMID: 20018989] doi:10.1215/03616878-2009-034 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Jefferson Clinical Research Institute, Thomas Jefferson University, Philadelphia, Pennsylvania (D.J.W.)Acknowledgment: The author thanks Melissa McCarey for her help in drafting the manuscript.Disclosures: Author has disclosed no conflicts of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-1656.Corresponding Author: David J. Whellan, MD, MHS, Jefferson Clinical Research Institute, Thomas Jefferson University, 1015 Chestnut Street, Suite 317, Philadelphia, PA 19107; e-mail, David.[email protected]edu.Author Contributions: Conception and design: D.J. Whellan.Analysis and interpretation of the data: D.J. Whellan.Drafting of the article: D.J. Whellan.Critical revision for important intellectual content: D.J. Whellan.Final approval of the article: D.J. Whellan.Administrative, technical, or logistic support: D.J. Whellan.Collection and assembly of data: D.J. Whellan.This article was published at Annals.org on 10 September 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byComparative effectiveness of biofeedback and injectable bulking agents for treatment of fecal incontinence: Design and methods 17 September 2019Volume 171, Issue 6Page: 430-431KeywordsClinical trialsConflicts of interestDisclosureHealth careHealth care policyHealth services administration and managementMedicareMotivationResearch ethicsResearch grants ePublished: 10 September 2019 Issue Published: 17 September 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...