Publications by authors named "Robert M Califf"

100Publications

Benchmarking the Cost-Effectiveness of Interventions Delaying Diabetes: A Simulation Study Based on NAVIGATOR Data.

Diabetes Care 2020 Aug 12. Epub 2020 Aug 12.

Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, U.K.

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http://dx.doi.org/10.2337/dc20-0717DOI Listing
August 2020

Weighing the Benefits and Risks of Proliferating Observational Treatment Assessments: Observational Cacophony, Randomized Harmony.

JAMA 2020 Jul 31. Epub 2020 Jul 31.

Nuffield Department of Population Health, University of Oxford, Headington, Oxford, United Kingdom.

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http://dx.doi.org/10.1001/jama.2020.13319DOI Listing
July 2020

COVID-19 Clinical Trials: A Teachable Moment for Improving Our Research Infrastructure and Relevance.

Ann Intern Med 2020 Jun 16. Epub 2020 Jun 16.

Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (E.L.O.).

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http://dx.doi.org/10.7326/M20-2959DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322771PMC
June 2020

Levels of evidence supporting drug, device, and other recommendations in the American Heart Association/American College of Cardiology guidelines.

Am Heart J 2020 Aug 8;226:4-12. Epub 2020 May 8.

Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.

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http://dx.doi.org/10.1016/j.ahj.2020.05.003DOI Listing
August 2020

Rural-Urban Differences in Cardiovascular Mortality in the US, 1999-2017.

JAMA 2020 05;323(18):1852-1854

Department of Medicine, Veterans Affairs Boston Healthcare System, Boston, Massachusetts.

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http://dx.doi.org/10.1001/jama.2020.2047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218488PMC
May 2020

Reimagining What We Measure in Atherosclerosis-a "Phenotype Stack".

Circ Res 2020 04 23;126(9):1146-1158. Epub 2020 Apr 23.

From the One Brave Idea (C.A.M., R.M.C.).

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http://dx.doi.org/10.1161/CIRCRESAHA.120.315941DOI Listing
April 2020

New Approaches to Conducting Randomized Controlled Trials.

J Am Coll Cardiol 2020 02;75(5):556-559

Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2019.11.043DOI Listing
February 2020

Understanding the use of observational and randomized data in cardiovascular medicine.

Eur Heart J 2020 Jul;41(27):2571-2578

Radcliffe Department of Medicine, Division of Cardiovascular Medicine, Level 6, West Wing, John Radcliffe Hospital, Oxford OX3 9DU, UK.

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http://dx.doi.org/10.1093/eurheartj/ehaa020DOI Listing
July 2020

Big Data in the Assessment of Pediatric Medication Safety.

Pediatrics 2020 02 14;145(2). Epub 2020 Jan 14.

Division of Cardiology, Department of Internal Medicine, School of Medicine, Center for Health Science, Duke Clinical Research Institute, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1542/peds.2019-0562DOI Listing
February 2020

Digital clinical trials: creating a vision for the future.

NPJ Digit Med 2019 12;2:126. Epub 2019 Dec 12.

5Verily Life Sciences, Alphabet Inc, South San Francisco, California, USA and Duke Forge, Duke University School of Medicine, Durham, NC USA.

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http://dx.doi.org/10.1038/s41746-019-0203-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6908600PMC
December 2019

Balanced Dysfunction in the Healthcare Ecosystem Harms Patients.

Authors:
Robert M Califf

Circulation 2019 12 2;140(23):1860-1864. Epub 2019 Dec 2.

Duke Forge, Duke University School of Medicine, Durham, NC. Department of Medicine, Stanford University School of Medicine, CA. Verily Life Sciences, South San Francisco, CA.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043935DOI Listing
December 2019

Consent for Research Participation in Practice.

Authors:
Robert M Califf

Am J Bioeth 2019 Apr;19(4):19-21

Duke University School of Medicine , Stanford University.

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http://dx.doi.org/10.1080/15265161.2019.1574492DOI Listing
April 2019

Oral Fluoroquinolones.

Authors:
Robert M Califf

J Am Coll Cardiol 2019 09;74(11):1451-1453

Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Science, South San Francisco, California. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2019.08.002DOI Listing
September 2019

Proposals to Lower Medication Costs-Reply.

JAMA 2019 09;322(10):982-983

United States of Care, Minneapolis, Minnesota.

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http://dx.doi.org/10.1001/jama.2019.10395DOI Listing
September 2019

Consequences of Slow Progress Toward Pragmatism in Randomized Clinical Trials: It Is Time to Get Practical.

JAMA Cardiol 2019 11;4(11):1129-1130

Division of Cardiovascular Medicine, Stanford University, Stanford, California.

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http://dx.doi.org/10.1001/jamacardio.2019.3922DOI Listing
November 2019

High-quality evidence to inform clinical practice.

Lancet 2019 08;394(10199):633-634

Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27701, USA. Electronic address:

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https://linkinghub.elsevier.com/retrieve/pii/S01406736193125
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http://dx.doi.org/10.1016/S0140-6736(19)31256-5DOI Listing
August 2019

Biomarkers and Clinical Cardiovascular Outcomes With Ezetimibe in the IMPROVE-IT Trial.

J Am Coll Cardiol 2019 08;74(8):1057-1068

TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2019.06.038DOI Listing
August 2019

The digital transformation of medicine can revitalize the patient-clinician relationship.

NPJ Digit Med 2018 20;1:49. Epub 2018 Sep 20.

6Section of Cardiovascular Medicine, Department of Medicine, Yale University School of Medicine, New Haven, CT USA.

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http://dx.doi.org/10.1038/s41746-018-0060-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6550259PMC
September 2018

Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example.

Contemp Clin Trials 2020 01 20;88:105775. Epub 2019 Jun 20.

Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, United States of America.

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http://dx.doi.org/10.1016/j.cct.2019.04.016DOI Listing
January 2020

Employ Cybersecurity Techniques Against the Threat of Medical Misinformation.

JAMA 2019 Jul;322(3):207-208

Duke Forge, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2019.6857DOI Listing
July 2019

Filling in the Evidence About Sunscreen.

JAMA 2019 06;321(21):2077-2079

Department of Dermatology, University of California, San Francisco.

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http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.20
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http://dx.doi.org/10.1001/jama.2019.5528DOI Listing
June 2019

Lowering Cost and Increasing Access to Drugs Without Jeopardizing Innovation.

JAMA 2019 04;321(16):1571-1573

Board Chair, United States of Care.

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http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.20
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http://dx.doi.org/10.1001/jama.2019.3846DOI Listing
April 2019

Reframing Global Variation in Heart Failure Trials: Thinking Beyond Location on the Map.

JACC Heart Fail 2019 04 6;7(4):347-349. Epub 2019 Feb 6.

Duke Forge, Duke University School of Medicine, Durham, North Carolina; Department of Medicine, Stanford University, Stanford, California; Verily Life Sciences (Alphabet), South San Francisco, California. Electronic address: https://twitter.com/califf001.

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http://dx.doi.org/10.1016/j.jchf.2018.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437717PMC
April 2019

Work and Cardiovascular Disease in China.

JAMA Netw Open 2018 11 2;1(7):e184815. Epub 2018 Nov 2.

Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, North Carolina.

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http://jamanetworkopen.jamanetwork.com/article.aspx?doi=10.1
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http://dx.doi.org/10.1001/jamanetworkopen.2018.4815DOI Listing
November 2018

Medication Discontinuation in the IMPROVE-IT Trial.

Circ Cardiovasc Qual Outcomes 2019 01;12(1):e005041

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.M.N., M.T.R., J.A.W., Y.L., L.K.N., M.A.B.).

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http://dx.doi.org/10.1161/CIRCOUTCOMES.118.005041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541480PMC
January 2019

Seven Former FDA Commissioners: The FDA Should Be An Independent Federal Agency.

Health Aff (Millwood) 2019 01;38(1):84-86

Frank Young is executive vice president of clinical and regulatory affairs at TissueTech, Inc., and Subsidiaries, in Miami, Florida. Dr. Young was FDA commissioner from 1984 to 1989.

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http://dx.doi.org/10.1377/hlthaff.2018.05185DOI Listing
January 2019

Differences in Health Outcomes between Men and Women: Biological, Behavioral, and Societal Factors.

Clin Chem 2019 01;65(1):19-23

Duke Forge, Duke University School of Medicine, Durham, NC;

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http://dx.doi.org/10.1373/clinchem.2018.287334DOI Listing
January 2019

Providing Individual Research Results to Participants-Reply.

JAMA 2018 12;320(24):2601

Duke Forge, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2018.18111DOI Listing
December 2018

Improving Clinical Outcomes in the Era of Information Ubiquity.

Authors:
Robert M Califf

J Am Soc Nephrol 2019 01;30(1):7-12

Duke Forge, Duke University School of Medicine, Durham, North Carolina;

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http://dx.doi.org/10.1681/ASN.2018111128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6317594PMC
January 2019

Future of Personalized Cardiovascular Medicine: JACC State-of-the-Art Review.

Authors:
Robert M Califf

J Am Coll Cardiol 2018 12;72(25):3301-3309

Duke Forge, Duke University School of Medicine, Durham, North Carolina; Verily Life Sciences (Alphabet), South San Francisco, California; Stanford University Department of Medicine, Stanford, California. Electronic address:

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https://linkinghub.elsevier.com/retrieve/pii/S07351097183891
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http://dx.doi.org/10.1016/j.jacc.2018.09.079DOI Listing
December 2018

Standardized classification and framework for reporting and interpreting medication non-adherence in clinical trials.

Eur Heart J 2019 07;40(25):2086-2088

Departmet of Medicine, Duke University School of Medicine, Durham, NC, USA.

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http://dx.doi.org/10.1093/eurheartj/ehy759DOI Listing
July 2019

The evolution of PCI registries: implementing a sustainable future for health systems and clinicians.

EuroIntervention 2018 Nov;14(10):1076-1079

The Duke Clinical Research Institute, Durham, NC, USA.

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http://www.pcronline.com/eurointervention/143rd_issue/193
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http://dx.doi.org/10.4244/EIJV14I10A193DOI Listing
November 2018

A Beginning to Principles of Ethical and Regulatory Oversight of Patient-Centered Research.

Authors:
Robert M Califf

Ann Intern Med 2018 10 25;169(8):579-580. Epub 2018 Sep 25.

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.).

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http://dx.doi.org/10.7326/M18-2517DOI Listing
October 2018

Natural History of Patients Postacute Coronary Syndrome Based on Heart Failure Status.

Am J Cardiol 2018 11 4;122(9):1451-1458. Epub 2018 Aug 4.

Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.

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http://dx.doi.org/10.1016/j.amjcard.2018.07.034DOI Listing
November 2018

Individual risk prediction using data beyond the medical clinic.

CMAJ 2018 08;190(32):E947-E948

Duke Forge (Califf), Duke University School of Medicine, Durham, NC; Verily Life Sciences (Alphabet) (Califf), South San Francisco, Calif.; Department of Biostatistics (Harrell), Vanderbilt University Medical Center, Nashville, Ten.

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http://dx.doi.org/10.1503/cmaj.180967DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6089946PMC
August 2018

Return of Research Results to Study Participants: Uncharted and Untested.

JAMA 2018 Aug;320(5):435-436

Duke Forge, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2018.7898DOI Listing
August 2018

Expedited and facilitated drug evaluations and evidence of benefit and risk: The cup is half-full.

Authors:
Robert M Califf

Clin Trials 2018 06;15(3):235-239

1 Duke Forge, Duke University School of Medicine, Durham, NC, USA.

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http://dx.doi.org/10.1177/1740774518771347DOI Listing
June 2018

Stroke prevention in atrial fibrillation: re-defining 'real-world data' within the broader data universe.

Eur Heart J 2018 08;39(32):2932-2941

Division of Cardiology, Duke Clinical Research Institute, Duke University, 2400 Pratt Street, Durham, NC USA.

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http://dx.doi.org/10.1093/eurheartj/ehy236DOI Listing
August 2018

Remembering Dr Ray Lipicky.

Circulation 2018 03;137(13):1309

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http://dx.doi.org/10.1161/CIRCULATIONAHA.118.034595DOI Listing
March 2018

Mass Customization, Ubiquitous Information, and Improvements to Health Outcomes in the United States.

Authors:
Robert M Califf

JAMA Cardiol 2018 05;3(5):365-366

Duke Forge, Duke University, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamacardio.2017.5354DOI Listing
May 2018

Biomarker definitions and their applications.

Authors:
Robert M Califf

Exp Biol Med (Maywood) 2018 02;243(3):213-221

1 12277 School of Medicine, Duke University , Durham, NC 27710, USA.

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http://dx.doi.org/10.1177/1535370217750088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5813875PMC
February 2018

Improving Heart Failure Therapeutics Development in the United States: The Heart Failure Collaboratory.

J Am Coll Cardiol 2018 01;71(4):443-453

Department of Medicine, Stanford University, Palo Alto, California; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina; Verily Life Sciences, South San Francisco, California.

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http://dx.doi.org/10.1016/j.jacc.2017.11.048DOI Listing
January 2018

Comparison of Observational Data and the ONTARGET Results for Telmisartan Treatment of Hypertension: Bull's-eye or Painting the Target Around the Arrow?

Authors:
Robert M Califf

JAMA Intern Med 2018 01;178(1):63-65

Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamainternmed.2017.5091DOI Listing
January 2018

Finding ideal blood pressure targets in ischaemic stroke: prospective insight or retrospective guesswork?

Authors:
Robert M Califf

Eur Heart J 2017 10;38(37):2836-2837

Duke Health and the Duke University School of Medicine, Durham, NC, USA; and Verily Life Sciences, South San Francisco, CA, USA.

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http://dx.doi.org/10.1093/eurheartj/ehx415DOI Listing
October 2017

Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk.

Authors:
Robert M Califf

JAMA 2017 08;318(7):614-616

Duke Health and Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jama.2017.9412DOI Listing
August 2017

Cosmetics, Regulations, and the Public Health: Understanding the Safety of Medical and Other Products.

JAMA Intern Med 2017 08;177(8):1080-1082

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamainternmed.2017.2773DOI Listing
August 2017

Evaluating Evolving Technologies in a Time of Rapid Change: The Case of Transcatheter Aortic Valve Replacement.

Authors:
Robert M Califf

JAMA Cardiol 2017 08;2(8):830-831

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.

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http://dx.doi.org/10.1001/jamacardio.2017.1733DOI Listing
August 2017

Warning About Shortcuts in Drug Development.

Authors:
Robert M Califf

J Am Heart Assoc 2017 03 21;6(3). Epub 2017 Mar 21.

Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC

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http://dx.doi.org/10.1161/JAHA.117.005737DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524047PMC
March 2017

JACC: Heart Failure Series: FDA in the 21st Century: Focus on Nutrition and Heart Failure Prevention.

JACC Heart Fail 2017 03;5(3):229-231

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1016/j.jchf.2016.12.012DOI Listing
March 2017

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Nat Rev Drug Discov 2017 May 24;16(5):297-298. Epub 2017 Feb 24.

US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.

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http://dx.doi.org/10.1038/nrd.2017.25DOI Listing
May 2017

FDA in the 21st Century: Focus on Tobacco Policies and Heart Failure Prevention.

JACC Heart Fail 2017 02;5(2):152-153

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1016/j.jchf.2016.11.010DOI Listing
February 2017

Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance.

Authors:
Robert M Califf

JAMA 2017 Feb;317(7):693-694

Formerly with the US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jama.2017.0410DOI Listing
February 2017

Regarding "Eteplirsen for the treatment of Duchenne muscular dystrophy".

Ann Neurol 2017 01;81(1):162-164

US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1002/ana.24842DOI Listing
January 2017

Transforming Evidence Generation to Support Health and Health Care Decisions.

N Engl J Med 2016 Dec;375(24):2395-2400

From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).

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http://dx.doi.org/10.1056/NEJMsb1610128DOI Listing
December 2016

Clarifying Stem-Cell Therapy's Benefits and Risks.

N Engl J Med 2017 Mar 30;376(11):1007-1009. Epub 2016 Nov 30.

From the Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1056/NEJMp1613723DOI Listing
March 2017

Real-World Evidence - What Is It and What Can It Tell Us?

N Engl J Med 2016 Dec;375(23):2293-2297

From the Office of the Commissioner (R.E.S., N.L.H., R.M.C.); the Office of Biostatistics and Epidemiology (S.A.A.) and the Office of the Center Director (P.W.M.), Center for Biologics Evaluation and Research; the Office of Surveillance and Epidemiology (G.J.D.P.), the Office of Biostatistics, the Office of Translational Sciences (L.L.), the Office of Medical Policy (M.A.R.), the Office of the Center Director (R.T., J.W.), Center for Drug Evaluation and Research, and the Division of Biostatistics (G.W.G., L.Q.Y.); and the Division of Epidemiology (D.M.-D.), Office of Surveillance and Biometrics (T.G.); and the Office of the Center Director (J.S.), Center for Devices and Radiological Health - all at the Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1056/NEJMsb1609216DOI Listing
December 2016

Knowing When and How to Use Medical Products: A Shared Responsibility for the FDA and CMS.

JAMA 2016 12;316(23):2485-2486

Centers for Medicare & Medicaid Services, Baltimore, Maryland.

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http://dx.doi.org/10.1001/jama.2016.16734DOI Listing
December 2016

The US Food and Drug Administration and the Future of Cardiovascular Medicine.

JAMA Cardiol 2016 11;1(8):950-952

The US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jamacardio.2016.2580DOI Listing
November 2016

Resourcing Drug Development Commensurate With its Public Health Importance: The Road Ahead.

JACC Basic Transl Sci 2016 Aug 29;1(5):309-312. Epub 2016 Aug 29.

U.S. Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1016/j.jacbts.2016.07.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6113418PMC
August 2016

The US Food and Drug Administration and Cardiovascular Medicine: Reflections and Observations.

Authors:
Robert M Califf

Circulation 2016 Aug;134(7):501-3

From US Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1161/CIRCULATIONAHA.116.022137DOI Listing
August 2016

The Future of Cardiovascular Medicine From the Regulatory Perspective.

Authors:
Robert M Califf

J Am Coll Cardiol 2016 08;68(7):766-9

U.S. Food and Drug Administration, Silver Spring, Maryland. Electronic address:

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http://dx.doi.org/10.1016/j.jacc.2016.07.001DOI Listing
August 2016

Need for a National Evaluation System for Health Technology.

JAMA 2016 Sep;316(11):1153-4

US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jama.2016.8708DOI Listing
September 2016

Pragmatic clinical trials: Emerging challenges and new roles for statisticians.

Authors:
Robert M Califf

Clin Trials 2016 10 3;13(5):471-7. Epub 2016 Jul 3.

US Food and Drug Administration, Silver Spring, MD, USA

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http://dx.doi.org/10.1177/1740774516656944DOI Listing
October 2016

Biomarkers and Surrogate Endpoints: Developing Common Terminology and Definitions.

JAMA 2016 Mar;315(11):1107-8

US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jama.2016.2240DOI Listing
March 2016

A Proactive Response to Prescription Opioid Abuse.

N Engl J Med 2016 Apr 4;374(15):1480-5. Epub 2016 Feb 4.

From the Food and Drug Administration, Silver Spring, MD.

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http://dx.doi.org/10.1056/NEJMsr1601307DOI Listing
April 2016

Remarks of the FDA Commissioner: The Food and Drug Law Institute's 59th Annual Conference.

Authors:
Robert M Califf

Food Drug Law J 2016;71(2):201-10

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December 2017

Altered Maturation Status and Possible Immune Exhaustion of CD8 T Lymphocytes in the Peripheral Blood of Patients Presenting With Acute Coronary Syndromes.

Arterioscler Thromb Vasc Biol 2016 Feb 10;36(2):389-97. Epub 2015 Dec 10.

From the Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve, University School of Medicine, Cleveland, OH (D.A.Z., S.J., J.P.L., M.I., M.A.A., M.M., M.A.C., D.I.S.); Division of Infectious Diseases, Department of Medicine (J.C.M., M.M.L.) and Department of Neurology (C.T.), Case Western Reserve University/University Hospitals of Cleveland, OH; Athersys, Inc., Cleveland, OH (S.S.P.); Department of Surgery (S.S., R.O., K.J.W.), Duke Heart Center (J.B.W.), and Department of Biostatistics and Bioinformatics (C.C.), and Duke Clinical Research Institute (R.M.C., L.K.N.), Duke University Medical Center, Durham, NC; Division of Medical Laboratory Science, School of Health and Rehabilitation Sciences, The Ohio State University, Columbus (N.T.F.); Case Western Reserve University School of Medicine, Cleveland, OH (A.O.); and Department of Medicine, University of Miami Health System, FL (C.O.).

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5079704PMC
http://dx.doi.org/10.1161/ATVBAHA.115.306112DOI Listing
February 2016

Engaging Patients Across the Spectrum of Medical Product Development: View From the US Food and Drug Administration.

JAMA 2015 Dec;314(23):2499-500

Office of Medical Products and Tobacco, US Food and Drug Administration, Silver Spring, Maryland.

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http://dx.doi.org/10.1001/jama.2015.15818DOI Listing
December 2015

Exploring the ethical and regulatory issues in pragmatic clinical trials.

Clin Trials 2015 Oct 15;12(5):436-41. Epub 2015 Sep 15.

Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.

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http://dx.doi.org/10.1177/1740774515598334DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4891194PMC
October 2015