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    Wyświetlanie 1-16 z 16
    Tytuł:
    Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study.
    Autorzy:
    Zou CX; Yale School of Medicine, New Haven, CT, USA.
    Becker JE; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.; McLean Hospital, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.
    Phillips AT; Division of Cardiovascular Medicine, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
    Garritano JM; Yale School of Medicine, New Haven, CT, USA.
    Krumholz HM; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
    Miller JE; Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT, 06520, USA.
    Ross JS; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. .; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .; Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT, 06520, USA. .
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    Źródło:
    Trials [Trials] 2018 Oct 23; Vol. 19 (1), pp. 581. Date of Electronic Publication: 2018 Oct 23.
    Typ publikacji:
    Comparative Study; Journal Article
    MeSH Terms:
    Drug Approval*
    Publication Bias*
    Registries*
    Research Design*
    United States Food and Drug Administration*
    Central Nervous System Agents/*therapeutic use
    Clinical Trials as Topic/*methods
    Mental Disorders/*drug therapy
    Central Nervous System Agents/adverse effects ; Data Accuracy ; Humans ; Mental Disorders/diagnosis ; Mental Disorders/physiopathology ; Mental Disorders/psychology ; Retrospective Studies ; Time Factors ; Treatment Outcome ; United States
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
    Tytuł:
    Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA.
    Autorzy:
    Swanson MJ; Frank H. Netter MD School of Medicine at Quinnipiac University, North Haven, CT, USA.
    Johnston JL; Yale School of Medicine, New Haven, CT, USA.
    Ross JS; Section of General Medicine and the National Clinician Scholars Program, Department of Internal Medicine, Yale School of Medicine, PO Box 208093, New Haven, CT, 06520, USA. .; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. .; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .
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    Źródło:
    Trials [Trials] 2021 Nov 17; Vol. 22 (1), pp. 817. Date of Electronic Publication: 2021 Nov 17.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Peer Review*
    Research Report*
    Drug Approval ; Humans ; PubMed ; United States ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs.
    Autorzy:
    Golish SR; Department of Surgery, Jupiter Medical Center, 1210 S. Old Dixie Hwy, Jupiter, Palm Beach, FL, 33458, USA. .
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    Źródło:
    Trials [Trials] 2017 Jul 24; Vol. 18 (1), pp. 348. Date of Electronic Publication: 2017 Jul 24.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Device Approval*
    Equivalence Trials as Topic*
    Orthotic Devices*
    Research Design*
    United States Food and Drug Administration*
    Randomized Controlled Trials as Topic/*methods
    Equipment Design ; Humans ; Medical Device Recalls ; Time Factors ; Treatment Outcome ; United States
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Association of the FDA Amendment Act with trial registration, publication, and outcome reporting.
    Autorzy:
    Phillips AT; Division of Cardiovascular Medicine, Department of Internal Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA. .
    Desai NR; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
    Krumholz HM; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.; Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.
    Zou CX; Yale School of Medicine, New Haven, CT, USA.
    Miller JE; Division of Medical Ethics, Department of Population Health, NYU School of Medicine, Bioethics International, New York, NY, USA.
    Ross JS; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .; Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA. .; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. .; Section of General Medicine, Department of Internal Medicine, Yale School of Medicine, P.O. Box 208093, New Haven, CT, 06520-8093, USA. .
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    Źródło:
    Trials [Trials] 2017 Jul 18; Vol. 18 (1), pp. 333. Date of Electronic Publication: 2017 Jul 18.
    Typ publikacji:
    Journal Article; Review
    MeSH Terms:
    Access to Information/*legislation & jurisprudence
    Cardiovascular Agents/*therapeutic use
    Clinical Trials as Topic/*legislation & jurisprudence
    Drug Approval/*legislation & jurisprudence
    Hypoglycemic Agents/*therapeutic use
    Outcome Assessment, Health Care/*legislation & jurisprudence
    Research Design/*legislation & jurisprudence
    United States Food and Drug Administration/*legislation & jurisprudence
    Cardiovascular Agents/adverse effects ; Clinical Trials as Topic/standards ; Government Regulation ; Humans ; Hypoglycemic Agents/adverse effects ; Outcome Assessment, Health Care/standards ; Registries ; Research Design/standards ; Treatment Outcome ; United States ; United States Food and Drug Administration/standards
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    The role of machine learning in clinical research: transforming the future of evidence generation.
    Autorzy:
    Weissler EH; Duke Clinical Research Institute, Duke University School of Medicine, Box 2834, Durham, NC, 27701, USA. .
    Naumann T; Microsoft Research, Cambridge, MA, USA.
    Andersson T; AstraZeneca, Gothenburg, Sweden.
    Ranganath R; Courant Institute of Mathematical Science, New York University, New York, NY, USA.
    Elemento O; Englander Institute for Precision Medicine, Weill Cornell Medical College, New York, NY, USA.
    Luo Y; Northwestern University Clinical and Translational Sciences Institute, Northwestern University, Chicago, IL, USA.
    Freitag DF; Division Pharmaceuticals, Open Innovation and Digital Technologies, Bayer AG, Wuppertal, Germany.
    Benoit J; University of Alberta, Edmonton, Alberta, Canada.
    Hughes MC; Department of Computer Science, Tufts University, Medford, MA, USA.
    Khan F; AstraZeneca, Gothenburg, Sweden.
    Slater P; Billion Minds, Inc., Seattle, WA, USA.
    Shameer K; AstraZeneca, Gothenburg, Sweden.
    Roe M; Verana Health, San Francisco, CA, USA.
    Hutchison E; AstraZeneca, Gothenburg, Sweden.
    Kollins SH; Duke Clinical Research Institute, Duke University School of Medicine, Box 2834, Durham, NC, 27701, USA.
    Broedl U; Boehringer-Ingelheim, Burlington, Canada.
    Meng Z; Sanofi, Cambridge, MA, USA.
    Wong JL; Sanofi, Washington, DC, USA.
    Curtis L; Duke Clinical Research Institute, Duke University School of Medicine, Box 2834, Durham, NC, 27701, USA.
    Huang E; Duke Clinical Research Institute, Duke University School of Medicine, Box 2834, Durham, NC, 27701, USA.; Duke Forge, Durham, NC, USA.
    Ghassemi M; Vector Institute, University of Toronto, Toronto, Ontario, Canada.; Department of Electrical Engineering and Computer Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, USA.; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, 02139, USA.; CIFAR AI Chair, Vector Institute, Toronto, Ontario, Canada.
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    Źródło:
    Trials [Trials] 2021 Aug 16; Vol. 22 (1), pp. 537. Date of Electronic Publication: 2021 Aug 16.
    Typ publikacji:
    Letter; Review
    MeSH Terms:
    Artificial Intelligence*
    Machine Learning*
    Humans ; United States ; United States Food and Drug Administration
    Recenzja
    Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
    Tytuł:
    Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov-evaluation of a new tracking tool for the US clinical trial registry.
    Autorzy:
    Keestra SM; Department of Global Health & Development, London School of Hygiene and Tropical Medicine, London, UK.; Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
    Rodgers F; School of Medicine, Imperial College London, London, UK. .
    Lenz D; Department of Science, Technology and Society, University of Vienna, Vienna, Austria.
    Osborne R; School of Clinical Medicine, University of Cambridge, Cambridge, UK.
    Bruckner T; BIH QUEST Center, Berlin, Germany.; TranspariMED, Bristol, UK.
    Lee S; Market Securities LLP, London, UK.
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    Źródło:
    Trials [Trials] 2021 Jun 01; Vol. 22 (1), pp. 375. Date of Electronic Publication: 2021 Jun 01.
    Typ publikacji:
    Letter
    MeSH Terms:
    Research Report*
    Universities*
    Humans ; Registries ; United Kingdom ; United States ; United States Food and Drug Administration
    Opinia redakcyjna
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Participation of the elderly, women, and minorities in pivotal trials supporting 2011-2013 U.S. Food and Drug Administration approvals.
    Autorzy:
    Downing NS; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
    Shah ND; Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA.
    Neiman JH; University of Nevada School of Medicine, Reno, NV, USA.
    Aminawung JA; Section of General Internal Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.
    Krumholz HM; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.; Section of Cardiovascular Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA.
    Ross JS; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .; Department of Health Policy and Management, Yale University School of Public Health, New Haven, CT, USA. .; Section of General Internal Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA. .
    Pokaż więcej
    Źródło:
    Trials [Trials] 2016 Apr 14; Vol. 17, pp. 199. Date of Electronic Publication: 2016 Apr 14.
    Typ publikacji:
    Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
    MeSH Terms:
    Drug Approval*
    Minority Groups*
    Patient Selection*
    United States Food and Drug Administration*
    Clinical Trials as Topic/*methods
    Adult ; Age Factors ; Aged ; Cross-Sectional Studies ; Databases, Factual ; Ethnicity ; Female ; Health Status Disparities ; Healthcare Disparities ; Humans ; Male ; Middle Aged ; Sex Factors ; Time Factors ; United States
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA.
    Autorzy:
    Talebi R; Section of Cardiovascular Medicine, Department of Medicine, University of California at San Francisco School of Medicine, San Francisco, CA, USA.
    Redberg RF; Section of Cardiovascular Medicine, Department of Medicine, University of California at San Francisco School of Medicine, San Francisco, CA, USA.
    Ross JS; Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA. .; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA. .; Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA. .
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    Źródło:
    Trials [Trials] 2020 Jul 23; Vol. 21 (1), pp. 675. Date of Electronic Publication: 2020 Jul 23.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Registries*
    Research Design*
    Clinical Trials, Phase III as Topic/*standards
    Research Report/*standards
    Cross-Sectional Studies ; Humans ; United States ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
    Tytuł:
    The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.
    Autorzy:
    Ladanie A; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.; Swiss Tropical and Public Health Institute (Swiss TPH), Socinstrasse 57, Basel, 4002, Switzerland.
    Speich B; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
    Naudet F; Univ Rennes, CHU Rennes, Inserm, CIC 1414 [(Centre d'Investigation Clinique de Rennes)], 22 rue Henri Le Guilloux, 35000, Rennes, France.
    Agarwal A; Department of Medicine, University of Toronto, 1 King's College Circle, Toronto, M5S 1A8, ON, Canada.; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4K1, ON, Canada.
    Pereira TV; Health Technology Assessment Unit, Institute of Education and Health Sciences, Oswaldo Cruz German Hospital, Rua João Julião, 245 1º andar, Bloco D, São Paulo, 01323-040, Brazil.
    Sclafani F; Department of Medicine, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, SM2 5PT, Surrey, UK.
    Martin-Liberal J; Catalan Institute of Oncology (ICO) Hospitalet, Melanoma, Sarcoma and GU Tumors Unit, Av Gran Via de L'Hospitalet 199-203, Barcelona, 08908, Spain.; Vall d'Hebron Institute of Oncology (VHIO), Early Drug Development Unit (UITM), Pg Vall d'Hebron, 119-129, Barcelona, 08035, Spain.
    Schmid T; St. Clara Hospital, Kleinriehenstrasse 30, Basel, 4058, Switzerland.
    Ewald H; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.; Swiss Tropical and Public Health Institute (Swiss TPH), Socinstrasse 57, Basel, 4002, Switzerland.; University Medical Library, University of Basel, Schönbeinstrasse 18-20, Basel, 4056, Switzerland.
    Ioannidis JPA; Meta-Research Innovation Center at Stanford (METRICS), Stanford University, 1265 Welch Road, Stanford, 94305, CA, USA.; Department of Medicine, Stanford University School of Medicine, 1265 Welch Road, Stanford, 94305, CA, USA.; Department of Health Research and Policy, Stanford University School of Medicine, 1265 Welch Road, Stanford, 94305, CA, USA.; Department of Biomedical Data Science, Stanford University School of Medicine, 1265 Welch Road, Stanford, 94305, CA, USA.; Department of Statistics, Stanford University School of Humanities and Sciences, 1265 Welch Road, Stanford, 94305, CA, USA.
    Bucher HC; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.
    Kasenda B; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland.; Medical Oncology, University Hospital and University of Basel, Petersgraben 4, Basel, 4031, Switzerland.
    Hemkens LG; Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital and University of Basel, Spitalstrasse 12, 4031, Basel, Switzerland. .
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    Źródło:
    Trials [Trials] 2018 Sep 19; Vol. 19 (1), pp. 505. Date of Electronic Publication: 2018 Sep 19.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Databases, Factual*
    Research Design*
    Antineoplastic Agents/*therapeutic use
    Biological Products/*therapeutic use
    Comparative Effectiveness Research/*methods
    Data Collection/*methods
    Drugs, Investigational/*therapeutic use
    Neoplasms/*drug therapy
    Antineoplastic Agents/adverse effects ; Biological Products/adverse effects ; Drug Approval ; Drugs, Investigational/adverse effects ; Humans ; Neoplasms/diagnosis ; Neoplasms/epidemiology ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; United States/epidemiology ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
    Tytuł:
    Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project.
    Autorzy:
    Meurer WJ; Department of Emergency Medicine, University of Michigan, TC B1-354 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA. .; Department of Neurology, University of Michigan, TC B1-354 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA. .
    Legocki L; Department of Family Medicine, University of Michigan, Ann Arbor, MI, 48109, USA.
    Mawocha S; Department of Emergency Medicine, University of Michigan, TC B1-354 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.
    Frederiksen SM; Department of Emergency Medicine, University of Michigan, TC B1-354 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.
    Guetterman TC; Department of Family Medicine, University of Michigan, Ann Arbor, MI, 48109, USA.
    Barsan W; Department of Emergency Medicine, University of Michigan, TC B1-354 1500 E. Medical Center Drive, Ann Arbor, MI, 48109, USA.
    Lewis R; Harbor-UCLA Medical Center, Torrance, CA, 90502, USA.
    Berry D; University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.
    Fetters M; Department of Family Medicine, University of Michigan, Ann Arbor, MI, 48109, USA.
    Pokaż więcej
    Źródło:
    Trials [Trials] 2016 Jul 29; Vol. 17, pp. 373. Date of Electronic Publication: 2016 Jul 29.
    Typ publikacji:
    Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.
    MeSH Terms:
    Clinical Trials as Topic*
    Research Design*
    Adult ; Attitude ; Culture ; Female ; Focus Groups ; Humans ; Male ; Middle Aged ; United States ; United States Food and Drug Administration ; Visual Analog Scale
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Improving the operational efficiency of Phase 2 and 3 trials.
    Autorzy:
    Ganju J; Global Blood Therapeutics, South San Francisco, CA, 94080, USA. .
    Pokaż więcej
    Źródło:
    Trials [Trials] 2016 Jul 20; Vol. 17 (1), pp. 332. Date of Electronic Publication: 2016 Jul 20.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Clinical Trials, Phase II as Topic*
    Clinical Trials, Phase III as Topic*
    Humans ; United States ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Expanded Access Programme: looking for a common definition.
    Autorzy:
    Iudicello A; Pharmaceutical Department, Azienda USL of Modena, Policlinico Hospital, Modena, Italy. .
    Alberghini L; Pharmaceutical Department, Azienda USL of Bologna, Maggiore Hospital, Largo B. Nigrisoli 2, 40133, Bologna, Italy. .
    Benini G; Pharmaceutical Department, Azienda USL of Bologna, Maggiore Hospital, Largo B. Nigrisoli 2, 40133, Bologna, Italy. .
    Mosconi P; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy. .
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    Źródło:
    Trials [Trials] 2016 Jan 12; Vol. 17, pp. 21. Date of Electronic Publication: 2016 Jan 12.
    Typ publikacji:
    Journal Article
    MeSH Terms:
    Clinical Trials as Topic*
    Compassionate Use Trials*
    Off-Label Use*
    Europe ; Humans ; Italy ; United States ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
    Autorzy:
    Matthew J. Swanson
    James L. Johnston
    Joseph S. Ross
    Pokaż więcej
    Temat:
    Clinical trials
    Publications
    Device approval
    United States Food and Drug Administration
    Medicine (General)
    R5-920
    Źródło:
    Trials, Vol 22, Iss 1, Pp 1-10 (2021)
    Opis pliku:
    electronic resource
    Relacje:
    https://doaj.org/toc/1745-6215
    Dostęp URL:
    https://doaj.org/article/71c1373a0d574587b16ff51186dbd5f8  Link otwiera się w nowym oknie
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Through the looking glass: understanding non-inferiority.
    Autorzy:
    Schumi J; Statistics Collaborative, Inc, Washington DC 20036, USA. />Wittes JT
    Pokaż więcej
    Źródło:
    Trials [Trials] 2011 May 03; Vol. 12, pp. 106. Date of Electronic Publication: 2011 May 03.
    Typ publikacji:
    Journal Article; Review
    MeSH Terms:
    Research Design*/legislation & jurisprudence
    Clinical Trials as Topic/*methods
    Evidence-Based Medicine/*methods
    Animals ; Clinical Trials as Topic/legislation & jurisprudence ; Device Approval ; Drug Approval ; Endpoint Determination ; Europe ; Evidence-Based Medicine/legislation & jurisprudence ; Government Regulation ; Humans ; Risk Assessment ; Sample Size ; Therapeutic Equivalency ; Treatment Outcome ; United States ; United States Food and Drug Administration
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
    Tytuł:
    Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs
    Autorzy:
    S. Raymond Golish
    Pokaż więcej
    Temat:
    Orthopedic surgery
    Medical devices
    Orthopedic surgical devices
    Spinal devices
    United States Food and Drug Administration
    Randomized clinical trials
    Medicine (General)
    R5-920
    Źródło:
    Trials, Vol 18, Iss 1, Pp 1-8 (2017)
    Opis pliku:
    electronic resource
    Relacje:
    http://link.springer.com/article/10.1186/s13063-017-2032-2; https://doaj.org/toc/1745-6215
    Dostęp URL:
    https://doaj.org/article/2f0bbff559d04649a2224f08e189cdea  Link otwiera się w nowym oknie
    Czasopismo naukowe
    Pełny tekst  Link otwiera się w nowym oknieSzczegóły
      Wyświetlanie 1-16 z 16

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