A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered Research
Authors: Robert M. Califf
Journal: Annals of Internal Medicine (2018)

Editorials16 October 2018A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered ResearchRobert M. Califf, MDRobert M. Califf, MDDuke Forge, Duke University School of Medicine, Durham, North Carolina, Verily Life Sciences (Alphabet), South San Francisco, California, and Stanford University Department of Medicine, Stanford, California (R.M.C.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-2517 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail This issue of Annals includes recommendations on ethical and regulatory issues related to the involvement of patients in the research process (1). The recommendations, which were produced by a panel funded by the Patient-Centered Outcomes Research Institute (PCORI), are organized into 3 categories: a description of roles for patients and oversight of those roles, oversight of the inclusion of emerging technologies in research protocols, and identification and engagement of patients in research. The panel used a Delphi process, beginning with extensive surveys of and interviews with relevant members of the research community. Based on these exchanges, draft recommendations were produced, ...References1. Gelinas L, Weissman JS, Lynch HF, Gupta A, Rozenblum R, Largent EA, et al; Delphi Working Group Participants. Oversight of patient-centered outcomes research: recommendations from a Delphi panel. Ann Intern Med. 2018;169:559-63. doi:10.7326/M18-1334 LinkGoogle Scholar2. Wilfond BS, Magnus D, Antommaria AH, Appelbaum P, Aschner J, Barrington KJ, et al. The OHRP and SUPPORT [Letter]. N Engl J Med. 2013;368:e36. [PMID: 23738513] doi:10.1056/NEJMc1307008 CrossrefMedlineGoogle Scholar3. Macklin R, Shepherd L, Dreger A, Asch A, Baylis F, Brody H, et al. The OHRP and SUPPORT—another view [Letter]. N Engl J Med. 2013;369:e3. [PMID: 23803134] doi:10.1056/NEJMc1308015 CrossrefMedlineGoogle Scholar4. U.S. Food and Drug Administration. Regulatory Information. 21st Century Cures Act. Silver Spring, MD: U.S. Food and Drug Administration; 2018. Accessed at www.fda.gov/regulatoryinformation/lawsenforcedbyfda/significantamendmentstothefdcact/21stcenturycuresact/default.htm on 6 September 2018. Google Scholar5. U.S. Food and Drug Administration. FDA User Fee Programs. Silver Spring, MD: U.S. Food and Drug Administration; 2018. Accessed at www.fda.gov/forindustry/userfees/default.htm on 9 September 2018. Google Scholar6. Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 2015;12:436-41. [PMID: 26374676] doi:10.1177/1740774515598334 CrossrefMedlineGoogle Scholar7. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;301:831-41. [PMID: 19244190] doi:10.1001/jama.2009.205 CrossrefMedlineGoogle Scholar8. Han H, Chao H, Guerra A, Sosa A, Christopoulos G, Christakopoulos GE, et al. Evolution of the American College of Cardiology/American Heart Association clinical guidelines. J Am Coll Cardiol. 2015;65:2726-34. [PMID: 26112197] doi:10.1016/j.jacc.2015.04.050 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Duke Forge, Duke University School of Medicine, Durham, North Carolina, Verily Life Sciences (Alphabet), South San Francisco, California, and Stanford University Department of Medicine, Stanford, California (R.M.C.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2517.Corresponding Author: Robert M. Califf, MD, Vice Chancellor for Health Data Science, Director, Duke Forge, Duke University School of Medicine, 401 Davison Building, Durham, NC 27710; e-mail, robert.[email protected]duke.edu.This article was published at Annals.org on 25 September 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoOversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel Luke Gelinas , Joel S. Weissman , Holly Fernandez Lynch , Avni Gupta , Ronen Rozenblum , Emily A. Largent , I. Glenn Cohen , and Metrics Cited byAdvancing community-engaged research: increasing trustworthiness within community-academic partnerships 16 October 2018Volume 169, Issue 8Page: 579-580KeywordsClinical trial reportingDisclosureHealth careInstitutional review boardsInternetPatient advocacyPatientsRandomized trialsResearch reporting guidelinesTreatment guidelines ePublished: 25 September 2018 Issue Published: 16 October 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...