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profileNicholas Sinclair Downing, M.D.

TitleClinical Fellow in Medicine (EXT)
InstitutionBrigham and Women's Hospital
DepartmentMedicine
AddressBrigham and Women's Hospital
Medicine/PBB-B4
75 Francis St
Boston MA 02115
Phone617/732-5775
Fax617/264-6346
vCardDownload vCard (login for email)

Collapse Bibliographic 
Collapse selected publications
Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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  1. Zeitoun JD, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post-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 Cancer. 2018 Jan 15; 142(2):414-423. PMID: 28929484.
    View in: PubMed
  2. Murugiah K, Wang Y, Nuti SV, Li X, Li J, Zheng X, Downing NS, Desai NR, Masoudi FA, Spertus JA, Jiang L, Krumholz HM. Are non-ST-segment elevation myocardial infarctions missing in China? Eur Heart J Qual Care Clin Outcomes. 2017 Oct 01; 3(4):319-327. PMID: 28950309.
    View in: PubMed
  3. Downing NS, Shah ND, Ross JS. Characteristics of Novel Therapeutics and Postmarket Safety Events-Reply. JAMA. 2017 09 19; 318(11):1067-1068. PMID: 28975302.
    View in: PubMed
  4. Downing NS, Cloninger A, Venkatesh AK, Hsieh A, Drye EE, Coifman RR, Krumholz HM. Describing the performance of U.S. hospitals by applying big data analytics. PLoS One. 2017; 12(6):e0179603. PMID: 28662045.
    View in: PubMed
  5. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents. N Engl J Med. 2017 06 29; 376(26):2598. PMID: 28657868.
    View in: PubMed
  6. Downing NS, Wang Y, Dharmarajan K, Nuti SV, Murugiah K, Du X, Zheng X, Li X, Li J, Masoudi FA, Spertus JA, Jiang L, Krumholz HM. Quality of Care in Chinese Hospitals: Processes and Outcomes After ST-segment Elevation Myocardial Infarction. J Am Heart Assoc. 2017 Jun 23; 6(6). PMID: 28645937.
    View in: PubMed
  7. Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010. JAMA. 2017 May 09; 317(18):1854-1863. PMID: 28492899.
    View in: PubMed
  8. Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 03; 357:j1680. PMID: 28468750.
    View in: PubMed
  9. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents - FDA versus EMA, 2011-2015. N Engl J Med. 2017 04 06; 376(14):1386-7. PMID: 28379798.
    View in: PubMed
  10. Zhao S, Murugiah K, Li N, Li X, Xu ZH, Li J, Cheng C, Mao H, Downing NS, Krumholz HM, Jiang LX. Admission Glucose and In-hospital Mortality after Acute Myocardial Infarction in Patients with or without Diabetes: A Cross-sectional Study. Chin Med J (Engl). 2017 Apr 05; 130(7):767-775. PMID: 28345539.
    View in: PubMed
  11. Larochelle M, Downing NS, Ross JS, David FS. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study. BMJ Open. 2017 Feb 08; 7(2):e014582. PMID: 28179418.
    View in: PubMed
  12. Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014. Otolaryngol Head Neck Surg. 2017 Apr; 156(4):683-692. PMID: 28116974.
    View in: PubMed
  13. Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014. Otolaryngol Head Neck Surg. 2017 Feb; 156(2):285-288. PMID: 28093943.
    View in: PubMed
  14. Downing NS, Li J. Ischaemic heart disease in China: the time to address rising mortality rates. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 01; 3(1):4-5. PMID: 28927183.
    View in: PubMed
  15. Mortazavi BJ, Downing NS, Bucholz EM, Dharmarajan K, Manhapra A, Li SX, Negahban SN, Krumholz HM. Analysis of Machine Learning Techniques for Heart Failure Readmissions. Circ Cardiovasc Qual Outcomes. 2016 Nov; 9(6):629-640. PMID: 28263938.
    View in: PubMed
  16. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Sep 01; 176(9):1391-3. PMID: 27428055.
    View in: PubMed
  17. Downing NS, Shah ND, Neiman JH, Aminawung JA, Krumholz HM, Ross JS. Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals. Trials. 2016 Apr 14; 17:199. PMID: 27079511; PMCID: PMC4832528.
  18. Zhang L, Li J, Li X, Nasir K, Zhang H, Wu Y, Hu S, Wang Q, Downing NS, Desai NR, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. National Assessment of Statin Therapy in Patients Hospitalized with Acute Myocardial Infarction: Insight from China PEACE-Retrospective AMI Study, 2001, 2006, 2011. PLoS One. 2016; 11(4):e0150806. PMID: 27058862; PMCID: PMC4825974.
  19. Zheng X, Curtis JP, Hu S, Wang Y, Yang Y, Masoudi FA, Spertus JA, Li X, Li J, Dharmarajan K, Downing NS, Krumholz HM, Jiang L. Coronary Catheterization and Percutaneous Coronary Intervention in China: 10-Year Results From the China PEACE-Retrospective CathPCI Study. JAMA Intern Med. 2016 Apr; 176(4):512-21. PMID: 26974883.
    View in: PubMed
  20. Du X, Pi Y, Dreyer RP, Li J, Li X, Downing NS, Li L, Feng F, Zhan L, Zhang H, Guan W, Xu X, Li SX, Lin Z, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design. Catheter Cardiovasc Interv. 2016 Dec; 88(7):E212-E221. PMID: 26945565.
    View in: PubMed
  21. Li J, Dreyer RP, Li X, Du X, Downing NS, Li L, Zhang HB, Feng F, Guan WC, Xu X, Li SX, Lin ZQ, Masoudi FA, Spertus JA, Krumholz HM, Jiang LX. China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design. Chin Med J (Engl). 2016 Jan 05; 129(1):72-80. PMID: 26712436; PMCID: PMC4797546.
  22. Lu J, Xuan S, Downing NS, Wu C, Li L, Krumholz HM, Jiang L. Protocol for the China PEACE (Patient-centered Evaluative Assessment of Cardiac Events) Million Persons Project pilot. BMJ Open. 2016 Jan 04; 6(1):e010200. PMID: 26729395; PMCID: PMC4716208.
  23. Yin ES, Downing NS, Li X, Singer SJ, Curry LA, Li J, Krumholz HM, Jiang L. Organizational culture in cardiovascular care in Chinese hospitals: a descriptive cross-sectional study. BMC Health Serv Res. 2015 Dec 21; 15:569. PMID: 26689591; PMCID: PMC4685633.
  24. Spatz ES, Jiang X, Lu J, Masoudi FA, Spertus JA, Wang Y, Li X, Downing NS, Nasir K, Du X, Li J, Krumholz HM, Liu X, Jiang L. Qingdao Port Cardiovascular Health Study: a prospective cohort study. BMJ Open. 2015 Dec 09; 5(12):e008403. PMID: 26656011; PMCID: PMC4679897.
  25. Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study. Pharmacoepidemiol Drug Saf. 2016 Jun; 25(6):687-94. PMID: 26554874.
    View in: PubMed
  26. Downing NS, Krumholz HM, Ross JS, Shah ND. Regulatory watch: Characterizing the US FDA's approach to promoting transformative innovation. Nat Rev Drug Discov. 2015 11; 14(11):740-1. PMID: 26435528.
    View in: PubMed
  27. Krumholz HM, Nuti SV, Downing NS, Normand SL, Wang Y. Mortality, Hospitalizations, and Expenditures for the Medicare Population Aged 65 Years or Older, 1999-2013. JAMA. 2015 Jul 28; 314(4):355-65. PMID: 26219053.
    View in: PubMed
  28. Guan W, Murugiah K, Downing N, Li J, Wang Q, Ross JS, Desai NR, Masoudi FA, Spertus JA, Li X, Krumholz HM, Jiang L. National 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 Assoc. 2015 Jun 12; 4(6):e001718. PMID: 26071031; PMCID: PMC4599529.
  29. Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS. Regulatory 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 Pharmacol. 2015 Oct; 80(4):716-26. PMID: 25808713; PMCID: PMC4594708 [Available on 10/01/16].
  30. Ross JS, Dzara K, Downing NS. Efficacy and safety concerns are important reasons why the FDA requires multiple reviews before approval of new drugs. Health Aff (Millwood). 2015 Apr; 34(4):681-8. PMID: 25847652.
    View in: PubMed
  31. Downing NS. Market exclusivity for top-selling pharmaceuticals: too long, too short, or just right? JAMA Intern Med. 2015 Apr; 175(4):637-8. PMID: 25664529.
    View in: PubMed
  32. Krumholz HM, Downing NS. Managing the information boundary of an organization: key aspect of translating research into practice. Circ Cardiovasc Qual Outcomes. 2014 Nov; 7(6):805-6. PMID: 25387775; PMCID: PMC4322936.
  33. Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison. PLoS One. 2014; 9(10):e109100. PMID: 25333986; PMCID: PMC4204813.
  34. Smithy JW, Downing NS, Ross JS. Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: a cross-sectional study. JAMA Intern Med. 2014 Sep; 174(9):1518-20. PMID: 25070357; PMCID: PMC4221247.
  35. Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Descriptions and interpretations of the ACCORD-Lipid trial in the news and biomedical literature: a cross-sectional analysis. JAMA Intern Med. 2014 Jul; 174(7):1176-82. PMID: 24796406; PMCID: PMC4124903.
  36. Downing NS, Ross JS. Withdrawal of Personal Genome Service--reply. JAMA. 2014 Jun 18; 311(23):2441-2. PMID: 24938574.
    View in: PubMed
  37. Downing NS, Ross JS. Trial evidence and approval of therapeutic agents--reply. JAMA. 2014 May; 311(20):2129. PMID: 24867021.
    View in: PubMed
  38. Downing NS, Ross JS. Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service. JAMA. 2014 Feb 26; 311(8):793-4. PMID: 24474248.
    View in: PubMed
  39. Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. JAMA. 2014 Jan 22-29; 311(4):368-77. PMID: 24449315; PMCID: PMC4144867.
  40. Downing NS, Ross JS, Krumholz HM. Generic competition in a flawed system: pill them, bill them-reply. Arch Intern Med. 2012 Oct 22; 172(19):1522-3. PMID: 23752463.
    View in: PubMed
  41. Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory review of novel therapeutics--comparison of three regulatory agencies. N Engl J Med. 2012 Jun 14; 366(24):2284-93. PMID: 22591257; PMCID: PMC3504361.
  42. Downing NS, Ross JS, Jackevicius CA, Krumholz HM. Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise. Arch Intern Med. 2012 May 14; 172(9):724-30. PMID: 22493409; PMCID: PMC3636774.
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