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Author Details

Nicholas S Downing
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital
2012
52
18
PMIDPaper TitleJournal TitlePublished Year
34110392Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.JAMA Netw Open2021
32220910Use of intravenous magnesium sulfate among patients with acute myocardial infarction in China from 2001 to 2015: China PEACE-Retrospective AMI Study.BMJ Open2020
32315070Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.JAMA Netw Open2020
31658831Identification of Racial Inequities in Access to Specialized Inpatient Heart Failure Care at an Academic Medical Center.Circ Heart Fail2019
28929484Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.Int J Cancer2018
30646146Association of Racial and Socioeconomic Disparities With Outcomes Among Patients Hospitalized With Acute Myocardial Infarction, Heart Failure, and Pneumonia: An Analysis of Within- and Between-Hospital Variation.JAMA Netw Open2018
30380383Complements from the Lung.N Engl J Med2018
29377075Factors Associated With Postmarketing Research for Approved Indications for Novel Medicines Approved by Both the FDA and EMA Between 2005 and 2010: A Multivariable Analysis.Clin Pharmacol Ther2018
29215916New and incremental FDA black box warnings from 2008 to 2015.Expert Opin Drug Saf2018
28657868Regulatory Review of New Therapeutic Agents.N Engl J Med2017
28379798Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015.N Engl J Med2017
28468750Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review.BMJ2017
28345539Admission Glucose and In-hospital Mortality after Acute Myocardial Infarction in Patients with or without Diabetes: A Cross-sectional Study.Chin Med J (Engl)2017
28179418Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.BMJ Open2017
28093943Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.Otolaryngol Head Neck Surg2017
28116974Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.Otolaryngol Head Neck Surg2017
28492899Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.JAMA2017
29158421Urban-Rural Comparisons in Hospital Admission, Treatments, and Outcomes for ST-Segment-Elevation Myocardial Infarction in China From 2001 to 2011: A Retrospective Analysis From the China PEACE Study (Patient-Centered Evaluative Assessment of Cardiac Events).Circ Cardiovasc Qual Outcomes2017
29273664Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study.BMJ Open2017
28950309Are non-ST-segment elevation myocardial infarctions missing in China?Eur Heart J Qual Care Clin Outcomes2017
28975302Characteristics of Novel Therapeutics and Postmarket Safety Events-Reply.JAMA2017
28645937Quality of Care in Chinese Hospitals: Processes and Outcomes After ST-segment Elevation Myocardial Infarction.J Am Heart Assoc2017
28927183Ischaemic heart disease in China: the time to address rising mortality rates.Eur Heart J Qual Care Clin Outcomes2017
28662045Describing the performance of U.S. hospitals by applying big data analytics.PLoS One2017
26945565The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design.Catheter Cardiovasc Interv2016
28263938Analysis of Machine Learning Techniques for Heart Failure Readmissions.Circ Cardiovasc Qual Outcomes2016
26554874Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.Pharmacoepidemiol Drug Saf2016
27428055Generic Drug Approvals Since the 1984 Hatch-Waxman Act.JAMA Intern Med2016
26712436China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design.Chin Med J (Engl)2016
27058862National Assessment of Statin Therapy in Patients Hospitalized with Acute Myocardial Infarction: Insight from China PEACE-Retrospective AMI Study, 2001, 2006, 2011.PLoS One2016
26974883Coronary Catheterization and Percutaneous Coronary Intervention in China: 10-Year Results From the China PEACE-Retrospective CathPCI Study.JAMA Intern Med2016
26729395Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project pilot.BMJ Open2016
27079511Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.Trials2016
25808713Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.Br J Clin Pharmacol2015
26435528Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation.Nat Rev Drug Discov2015
26656011Qingdao Port Cardiovascular Health Study: a prospective cohort study.BMJ Open2015
26689591Organizational culture in cardiovascular care in Chinese hospitals: a descriptive cross-sectional study.BMC Health Serv Res2015
26071031National quality assessment evaluating spironolactone use during hospitalization for acute myocardial infarction (AMI) in China: China Patient-centered Evaluation Assessment of Cardiac Events (PEACE)-Retrospective AMI Study, 2001, 2006, and 2011.J Am Heart Assoc2015
26219053Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013.JAMA2015
25847652Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs.Health Aff (Millwood)2015
25664529Market exclusivity for top-selling pharmaceuticals: too long, too short, or just right?JAMA Intern Med2015
24474248Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service.JAMA2014
25387775Managing the information boundary of an organization: key aspect of translating research into practice.Circ Cardiovasc Qual Outcomes2014
25333986Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.PLoS One2014
25070357Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study.JAMA Intern Med2014
24796406Descriptions and interpretations of the ACCORD-Lipid trial in the news and biomedical literature: a cross-sectional analysis.JAMA Intern Med2014
24867021Trial evidence and approval of therapeutic agents--reply.JAMA2014
24938574Withdrawal of Personal Genome Service--reply.JAMA2014
24449315Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.JAMA2014
22591257Regulatory review of novel therapeutics--comparison of three regulatory agencies.N Engl J Med2012
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Collaborators

Yale School of Medicine
Co-authored papers 32
Yale School of Medicine
Co-authored papers 28
Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen China.
Co-authored papers 12
Renji Hospital, Shanghai Jiao Tong University
Co-authored papers 12
First Affiliated Hospital of Guangxi Medical University
Co-authored papers 12
Mayo Clinic
Co-authored papers 11
University of Colorado School of Medicine
Co-authored papers 10
University of Missouri-Kansas City School of Medicine
Co-authored papers 10
Center for Outcomes Research and Evaluation, Yale-New Haven Hospital
Co-authored papers 6
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Co-authored papers 5
Center for Outcomes Research and Evaluation, Yale University School of Medicine
Co-authored papers 3
Center for Outcomes Research and Evaluation, Yale University School of Medicine
Co-authored papers 3
Brigham and Women's Hospital.
Co-authored papers 3
Keenan Research Centre for Biomedical Science of St. Michael's Hospital
Co-authored papers 2
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Co-authored papers 2
Fuwai Hospital, Chinese Academy of Medical Sciences
Co-authored papers 2
Center for Health Data Science and Analytics
Co-authored papers 2
Harvard Medical School
Co-authored papers 2
New York University School of Medicine
Co-authored papers 1
Yale University School of Medicine
Co-authored papers 1
Co-authored papers 1
University of California san francisco
Co-authored papers 1
Center for Outcomes Research and Evaluation, Yale New Haven Hospital
Co-authored papers 1
Stanford University School of Medicine.
Co-authored papers 1
Yale/YNHH Center for Outcomes Research and Evaluation (CORE)
Co-authored papers 1
Yale School of Medicine
Co-authored papers 1
Yale University
Co-authored papers 1
University of Washington School of Medicine
Co-authored papers 1
Co-authored papers 1
Yale School of Public Health
Co-authored papers 1