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Tytuł :
Association Between USMLE Step 1 Scores and In-Training Examination Performance: A Meta-Analysis.
Autorzy :
Panda N; N. Panda is clinical fellow of surgery, Massachusetts General Hospital and Harvard Medical School, and postdoctoral researcher, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. D. Bahdila is doctoral candidate, Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston, Massachusetts, and Department of Preventive Dental Sciences, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia. A. Abdullah is doctoral candidate, Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine, Boston, Massachusetts, and Department of Preventive Dental Sciences, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia. A.J. Ghosh is clinical fellow of medicine and postdoctoral researcher, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. S.Y. Lee is research assistant, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts. W.B. Feldman is clinical fellow of medicine and postdoctoral researcher, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Bahdila D
Abdullah A
Ghosh AJ
Lee SY
Feldman WB
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Źródło :
Academic medicine : journal of the Association of American Medical Colleges [Acad Med] 2021 Jul 27. Date of Electronic Publication: 2021 Jul 27.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Empirical Assessment of U.S. Coronavirus Disease 2019 Crisis Standards of Care Guidelines.
Autorzy :
Bharadwaj M; Harvard Medical School, Boston, MA.
Jezmir JL; Harvard Medical School, Boston, MA.; Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Kishore SP; Harvard Medical School, Boston, MA.; Department of Medicine, Brigham and Women's Hospital, Boston, MA.; Department of Health System Design & Global Health, Icahn School of Medicine at Mount Sinai, New York, NY.
Winkler M; Harvard Medical School, Boston, MA.; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Diephus B; Harvard Medical School, Boston, MA.; Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Haider H; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Crowley CP; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Pinilla-Vera M; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Varon J; Harvard Medical School, Boston, MA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Baron RM; Harvard Medical School, Boston, MA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Feldman WB; Harvard Medical School, Boston, MA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA.
Kim EY; Harvard Medical School, Boston, MA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA.
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Źródło :
Critical care explorations [Crit Care Explor] 2021 Jul 15; Vol. 3 (7), pp. e0496. Date of Electronic Publication: 2021 Jul 15 (Print Publication: 2021).
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Autorzy :
Sarpatwari A; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. .
Mitra-Majumdar M; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Bykov K; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Avorn J; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Woloshin S; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.; Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH, USA.
Toyserkani GA; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
LaCivita C; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Manzo C; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Zhou EH; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Pinnow E; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Dal Pan GJ; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Gagne JJ; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Huybrechts KF; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Feldman WB; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Chin K; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Kesselheim AS; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
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Źródło :
Drug safety [Drug Saf] 2021 Jul; Vol. 44 (7), pp. 743-751. Date of Electronic Publication: 2021 Apr 27.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Correlation Between Changes in Brand-Name Drug Prices and Patient Out-of-Pocket Costs.
Autorzy :
Rome BN; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
Feldman WB; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Desai RJ; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
Kesselheim AS; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
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Źródło :
JAMA network open [JAMA Netw Open] 2021 May 03; Vol. 4 (5), pp. e218816. Date of Electronic Publication: 2021 May 03.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Why France Spends Less Than the United States on Drugs: A Comparative Study of Drug Pricing and Pricing Regulation.
Autorzy :
Raimond VC; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.; Harvard Medical School.
Feldman WB; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.; Harvard Medical School.; Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital.
Rome BN; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.; Harvard Medical School.
Kesselheim AS; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.; Harvard Medical School.
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Źródło :
The Milbank quarterly [Milbank Q] 2021 Mar; Vol. 99 (1), pp. 240-272.
Typ publikacji :
Comparative Study; Journal Article
MeSH Terms :
Cost Savings*
Government Regulation*
Medicare Part D/*economics
Prescription Drugs/*economics
Costs and Cost Analysis ; Drug Costs/legislation & jurisprudence ; France ; Insurance Coverage ; Legislation, Drug ; United States
Czasopismo naukowe
Tytuł :
Trends in Medicare Part D Inhaler Spending: 2012-2018.
Autorzy :
Feldman WB; Brigham and Women's Hospital Boston, Massachusetts and.; Harvard Medical School Boston, Massachusetts.
Gagne JJ; Brigham and Women's Hospital Boston, Massachusetts and.; Harvard Medical School Boston, Massachusetts.
Kesselheim AS; Brigham and Women's Hospital Boston, Massachusetts and.; Harvard Medical School Boston, Massachusetts.
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Źródło :
Annals of the American Thoracic Society [Ann Am Thorac Soc] 2021 Mar; Vol. 18 (3), pp. 548-550.
Typ publikacji :
Letter; Research Support, N.I.H., Extramural
Raport
Tytuł :
The Future of Drug-Pricing Transparency.
Autorzy :
Feldman WB; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics (W.B.F., B.N.R., J.A., A.S.K.) and the Division of Pulmonary and Critical Care Medicine (W.B.F.), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (W.B.F., B.N.R., J.A., A.S.K.) - both in Boston.
Rome BN; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics (W.B.F., B.N.R., J.A., A.S.K.) and the Division of Pulmonary and Critical Care Medicine (W.B.F.), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (W.B.F., B.N.R., J.A., A.S.K.) - both in Boston.
Avorn J; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics (W.B.F., B.N.R., J.A., A.S.K.) and the Division of Pulmonary and Critical Care Medicine (W.B.F.), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (W.B.F., B.N.R., J.A., A.S.K.) - both in Boston.
Kesselheim AS; From the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics (W.B.F., B.N.R., J.A., A.S.K.) and the Division of Pulmonary and Critical Care Medicine (W.B.F.), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School (W.B.F., B.N.R., J.A., A.S.K.) - both in Boston.
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Źródło :
The New England journal of medicine [N Engl J Med] 2021 Feb 11; Vol. 384 (6), pp. 489-491. Date of Electronic Publication: 2021 Jan 13.
Typ publikacji :
Journal Article
MeSH Terms :
Disclosure/*legislation & jurisprudence
Drug Costs/*legislation & jurisprudence
Drug Industry/*legislation & jurisprudence
Prescription Drugs/*economics
Advertising/legislation & jurisprudence ; Humans ; Insurance, Pharmaceutical Services ; Medicare ; United States
Czasopismo naukowe
Tytuł :
Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study.
Autorzy :
Liu M; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.; 1811Harvard Medical School, Boston 02115, USA.; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston 02120, USA.
MacKenna B; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.
Feldman WB; 1811Harvard Medical School, Boston 02115, USA.; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston 02120, USA.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston 02115, USA.
Walker AJ; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.
Avorn J; 1811Harvard Medical School, Boston 02115, USA.; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston 02120, USA.
Kesselheim AS; 1811Harvard Medical School, Boston 02115, USA.; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston 02120, USA.
Goldacre B; The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.
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Źródło :
Journal of the Royal Society of Medicine [J R Soc Med] 2020 Sep; Vol. 113 (9), pp. 350-359.
Typ publikacji :
Comparative Study; Journal Article
MeSH Terms :
Drug Costs/*statistics & numerical data
Medicare Part D/*economics
Primary Health Care/*economics
State Medicine/*economics
Cross-Sectional Studies ; England ; Forecasting ; Humans ; United States
Czasopismo naukowe
Tytuł :
Drug Prices, Rebates, and Discounts.
Autorzy :
Rome BN; Program on Regulation, Therapeutics, and Law (PORTAL), Brigham and Women's Hospital, Boston, Massachusetts.
Feldman WB; Program on Regulation, Therapeutics, and Law (PORTAL), Brigham and Women's Hospital, Boston, Massachusetts.
Kesselheim AS; Program on Regulation, Therapeutics, and Law (PORTAL), Brigham and Women's Hospital, Boston, Massachusetts.
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Źródło :
JAMA [JAMA] 2020 Jul 28; Vol. 324 (4), pp. 399.
Typ publikacji :
Letter; Comment
MeSH Terms :
Drug Costs*
Drug Industry*
Opinia redakcyjna
Tytuł :
Empirical Assessment of COVID-19 Crisis Standards of Care Guidelines.
Autorzy :
Jezmir JL; Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Bharadwaj M; Harvard Medical School, Boston, MA 02115.
Kishore SP; Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Winkler M; Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Diephuis B; Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Kim EY; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
Feldman WB; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA 02115.
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Źródło :
MedRxiv : the preprint server for health sciences [medRxiv] 2020 May 19. Date of Electronic Publication: 2020 May 19.
Typ publikacji :
Preprint
Tytuł :
Estimation of Medicare Part D Spending on Insulin for Patients With Diabetes Using Negotiated Prices and a Defined Formulary.
Autorzy :
Feldman WB; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
Rome BN; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
Lehmann LS; Harvard Medical School, Boston, Massachusetts.; US Department of Veteran Affairs, New England Healthcare System, Boston, Massachusetts.; Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
Kesselheim AS; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.; Harvard Medical School, Boston, Massachusetts.
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Źródło :
JAMA internal medicine [JAMA Intern Med] 2020 Apr 01; Vol. 180 (4), pp. 597-601.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
MeSH Terms :
United States Department of Veterans Affairs*
Diabetes Mellitus/*drug therapy
Hypoglycemic Agents/*economics
Insulin/*economics
Medicare Part D/*economics
Diabetes Mellitus/epidemiology ; Drug Prescriptions/economics ; Formularies as Topic ; Humans ; Insurance Benefits/economics ; United States/epidemiology
Czasopismo naukowe
Tytuł :
Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.
Autorzy :
Feldman WB; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Avorn J; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Kesselheim AS; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
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Źródło :
JAMA internal medicine [JAMA Intern Med] 2020 Mar 01; Vol. 180 (3), pp. 454-456.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
MeSH Terms :
Cost Savings*
Drug Costs*
Medicare Part D/*economics
Nebulizers and Vaporizers/*economics
Humans ; Prescriptions ; United States
Czasopismo naukowe
Tytuł :
When is the right time to discuss ECMO?
Autorzy :
Feldman WB; Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA, 02115, USA; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Keller SP; Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital, Boston, MA, 02115, USA; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA. Electronic address: .
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Źródło :
The Lancet. Respiratory medicine [Lancet Respir Med] 2019 Nov; Vol. 7 (11), pp. 939-940. Date of Electronic Publication: 2019 Aug 12.
Typ publikacji :
Journal Article
MeSH Terms :
Clinical Decision-Making*
Patient Care Planning*
Extracorporeal Membrane Oxygenation/*psychology
Physician's Role/*psychology
Humans ; Patient Selection ; Physician-Patient Relations ; Time Factors
Czasopismo naukowe
Tytuł :
Surrogate Endpoints and Drug Regulation: What Is Needed to Clarify the Evidence.
Autorzy :
Hey SP; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.
Feldman WB; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.
Jung EH; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.
D'Andrea E; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.
Kesselheim AS; Spencer Phillips Hey, Ph.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and Center for Bioethics, Harvard Medical School. William B. Feldman, M.D., D.Phil., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital. Emily H. Jung, A.B., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Elvira D'Andrea, M.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Aaron S. Kesselheim, M.D., J.D., M.P.H., Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts and the Center for Bioethics, Harvard Medical School.
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Źródło :
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2019 Sep; Vol. 47 (3), pp. 381-387.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Biomarkers*
United States Food and Drug Administration*
Guidelines as Topic/*standards
Drug Approval/legislation & jurisprudence ; Drug Approval/organization & administration ; Humans ; United States
Czasopismo naukowe
Tytuł :
Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.
Autorzy :
Feldman WB; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Hey SP; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Harvard Medical School Center for Bioethics, Boston, Massachusetts.
Franklin JM; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Kesselheim AS; Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.; Harvard Medical School Center for Bioethics, Boston, Massachusetts.
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Źródło :
JAMA network open [JAMA Netw Open] 2019 Jul 03; Vol. 2 (7), pp. e197591. Date of Electronic Publication: 2019 Jul 03.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Systematic Review
MeSH Terms :
Emergency Medical Services*
Clinical Trials as Topic/*psychology
Community Participation/*psychology
Informed Consent/*psychology
Research Subjects/*psychology
Adult ; Canada ; Clinical Trials as Topic/legislation & jurisprudence ; Community Participation/legislation & jurisprudence ; Female ; Humans ; Informed Consent/legislation & jurisprudence ; Male ; Middle Aged ; Research Subjects/legislation & jurisprudence ; United States ; United States Food and Drug Administration
Czasopismo naukowe
Tytuł :
A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway.
Autorzy :
Feldman WB; William B. Feldman ( ) is a research fellow at Harvard Medical School and a fellow in the Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, in Boston, Massachusetts.
Hey SP; Spencer Phillips Hey is a faculty member and codirector of research ethics at the Harvard Center for Bioethics and a research scientist in the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.
Kesselheim AS; Aaron S. Kesselheim is an associate professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital.
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Źródło :
Health affairs (Project Hope) [Health Aff (Millwood)] 2018 Oct; Vol. 37 (10), pp. 1605-1614.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Systematic Review
MeSH Terms :
Informed Consent*
Randomized Controlled Trials as Topic*
United States Food and Drug Administration*
Research Design/*standards
African Americans/statistics & numerical data ; Humans ; Research Design/trends ; United States
Czasopismo naukowe
Tytuł :
Response by Feldman et al to Letter Regarding Article, "Trends in Recruitment Rates for Acute Stroke Trials, 1990-2014".
Autorzy :
Feldman WB; Department of Medicine, Brigham and Women's Hospital, Boston, MA.
Kim AS; Department of Neurology, Weill Institute for Neurosciences, University of California San Francisco.
Chiong W; Department of Neurology, Memory and Aging Center, Weill Institute for Neurosciences, University of California San Francisco.
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Źródło :
Stroke [Stroke] 2017 Jun; Vol. 48 (6), pp. e145. Date of Electronic Publication: 2017 May 04.
Typ publikacji :
Letter; Comment
MeSH Terms :
Stroke*
Humans
Opinia redakcyjna
Tytuł :
Trends in Recruitment Rates for Acute Stroke Trials, 1990-2014.
Autorzy :
Feldman WB; From the Department of Medicine, Brigham and Women's Hospital, Boston, MA (W.B.F.); Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco (A.S.K, W.C.); and the University of California, San Francisco Memory and Aging Center (W.C.). .
Kim AS; From the Department of Medicine, Brigham and Women's Hospital, Boston, MA (W.B.F.); Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco (A.S.K, W.C.); and the University of California, San Francisco Memory and Aging Center (W.C.).
Chiong W; From the Department of Medicine, Brigham and Women's Hospital, Boston, MA (W.B.F.); Department of Neurology, Weill Institute for Neurosciences, University of California, San Francisco (A.S.K, W.C.); and the University of California, San Francisco Memory and Aging Center (W.C.).
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Źródło :
Stroke [Stroke] 2017 Mar; Vol. 48 (3), pp. 799-801. Date of Electronic Publication: 2017 Jan 19.
Typ publikacji :
Journal Article; Review; Systematic Review
MeSH Terms :
Clinical Trials as Topic*
Patient Selection*
Stroke/*therapy
Humans ; Registries/statistics & numerical data ; Time Factors
Czasopismo naukowe
Tytuł :
Effect of waivers of consent on recruitment in acute stroke trials: A systematic review.
Autorzy :
Feldman WB; From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco. .
Kim AS; From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco.
Josephson SA; From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco.
Lowenstein DH; From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco.
Chiong W; From the School of Medicine (W.B.F.), Department of Neurology (A.S.K., S.A.J., D.H.L., W.C.), and Memory and Aging Center (W.C.), University of California, San Francisco.
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Źródło :
Neurology [Neurology] 2016 Apr 19; Vol. 86 (16), pp. 1543-51. Date of Electronic Publication: 2016 Mar 23.
Typ publikacji :
Journal Article; Review; Systematic Review
MeSH Terms :
Informed Consent*
Patient Selection*
Stroke*/therapy
Randomized Controlled Trials as Topic/*methods
Humans
Czasopismo naukowe

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