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Wyszukujesz frazę ""CLINICAL trials"" wg kryterium: Temat


Tytuł:
Optimal adaptive single-arm phase II trials under quantified uncertainty.
Autorzy:
Kunzmann K; Institute of Biometry and Medical Informatics, University of Heidelberg, Heidelberg, Germany.
Kieser M; Institute of Biometry and Medical Informatics, University of Heidelberg, Heidelberg, Germany.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020; Vol. 30 (1), pp. 89-103. Date of Electronic Publication: 2019 Apr 25.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Adaptive Clinical Trials as Topic/*statistics & numerical data
Clinical Trials, Phase II as Topic/*statistics & numerical data
Research Design/*statistics & numerical data
Bayes Theorem ; Data Interpretation, Statistical ; Early Termination of Clinical Trials/statistics & numerical data ; Humans ; Time Factors ; Treatment Outcome ; Uncertainty
Czasopismo naukowe
Tytuł:
Optimal sample size determination for single-arm trials in pediatric and rare populations with Bayesian borrowing.
Autorzy:
Ji Z; Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, United States.
Lin J; Statistical and Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, Massachusetts, United States.
Lin J; Statistical and Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, Massachusetts, United States.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2022 Jul 04; Vol. 32 (4), pp. 529-546. Date of Electronic Publication: 2022 May 23.
Typ publikacji:
Journal Article
MeSH Terms:
Clinical Trials as Topic*/methods
Research Design*
Bayes Theorem ; Child ; Computer Simulation ; Humans ; Neoplasms/therapy ; Rare Diseases/therapy ; Sample Size
Czasopismo naukowe
Tytuł:
A simulation study of approaches for handling disease progression in dose-finding clinical trials.
Autorzy:
Biard L; Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.; INSERM U1153 team ECSTRRA, Université de Paris, Paris, France.
Cheng B; Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
Manji GA; Division of Medical Oncology, Columbia University Irving Medical Center, and New York Presbyterian Hospital, Herbert Irving Pavilion, New York, NY, USA.
Lee SM; Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2021 Mar; Vol. 31 (2), pp. 156-167. Date of Electronic Publication: 2020 Sep 15.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Clinical Trials as Topic*
Research Design*
Computer Simulation ; Disease Progression ; Humans
Czasopismo naukowe
Tytuł:
A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research.
Autorzy:
Seifu Y; Amgen, Inc., One, Thousand Oaks, California, USA.
Gamalo-Siebers M; Pfizer, Collegeville, Pennsylvania, USA.
Lin J; Takeda Pharmaceutical Co. Limited, Cambridge, Massachusetts, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2021 Mar; Vol. 31 (2), pp. 113-116. Date of Electronic Publication: 2021 Mar 07.
Typ publikacji:
Introductory Journal Article
MeSH Terms:
Clinical Trials as Topic*
Research Design*
Forecasting ; Humans
Czasopismo naukowe
Tytuł:
Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment.
Autorzy:
Wang T; Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Wang X; Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
George SL; Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Zhou H; Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1060-1076. Date of Electronic Publication: 2020 Nov 11.
Typ publikacji:
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms:
Clinical Trials as Topic*
Research Design*
Biomarkers ; Humans ; Probability
Czasopismo naukowe
Tytuł:
Risk difference, relative risk, and odds ratio for non-inferiority clinical trials with risk rate endpoint.
Autorzy:
Ni, Senmiao (AUTHOR)
Yu, Quanji (AUTHOR)
Zhong, Zihang (AUTHOR)
Yang, Min (AUTHOR)
Zhao, Yang (AUTHOR)
Wu, Jingwei (AUTHOR)
Bai, Jianling (AUTHOR)
Yu, Hao (AUTHOR)
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Źródło:
Journal of Biopharmaceutical Statistics. 2023, Vol. 33 Issue 1, p15-30. 16p. 4 Charts, 6 Graphs.
Czasopismo naukowe
Tytuł:
Statistical and practical considerations in designing of immuno-oncology trials.
Autorzy:
Mukhopadhyay P; Oncology Biometrics, AstraZeneca, Gaithersburg, USA.
Huang W; Biostatistics, Moderna, Cambridge, USA.
Metcalfe P; Oncology Biometrics, AstraZeneca, Melbourn, UK.
Öhrn F; Early Biometrics and Statistical Innovation, AstraZeneca, Mölndal, Sweden.
Jenner M; Qi Statistics, Kent, West Malling, UK.
Stone A; Stone Biostatistics Limited, Cranage, Crewe, UK.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1130-1146. Date of Electronic Publication: 2020 Sep 10.
Typ publikacji:
Journal Article
MeSH Terms:
Clinical Trials as Topic*
Neoplasms*/therapy
Research Design*
Humans ; Immunotherapy ; Probability ; Proportional Hazards Models ; Sample Size
Czasopismo naukowe
Tytuł:
Continual reassessment method with regularization in phase I clinical trials.
Autorzy:
Li X; Statistics and Decision Sciences, Janssen Research & Development, LLC, Raritan, NJ, USA.
Ivanova A; Department of Biostatistics, University of North Carolina at Chapel Hill, NC, USA.
Tian H; Statistics and Decision Sciences, Janssen Research & Development, LLC, Raritan, NJ, USA.
Lim P; Statistics and Decision Sciences, Janssen Research & Development, LLC, Titusville, NJ, USA.
Liu K; Biostatistics, Genmab, Princeton, NJ, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 964-978. Date of Electronic Publication: 2020 Sep 14.
Typ publikacji:
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms:
Clinical Trials, Phase I as Topic*
Research Design*
Computer Simulation ; Dose-Response Relationship, Drug ; Humans ; Maximum Tolerated Dose ; Probability
Czasopismo naukowe
Tytuł:
Futility stopping in clinical trials, optimality and practical considerations.
Autorzy:
Chang Y; Department of Biostatistics, The University of North Carolina, Chapel Hill, North Carolina, USA.
Song T; Department of Biostatistics, The University of North Carolina, Chapel Hill, North Carolina, USA.
Monaco J; Department of Biostatistics, The University of North Carolina, Chapel Hill, North Carolina, USA.
Ivanova A; Department of Biostatistics, The University of North Carolina, Chapel Hill, North Carolina, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1050-1059. Date of Electronic Publication: 2020 Sep 14.
Typ publikacji:
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms:
Clinical Trials as Topic*
Medical Futility*
Research Design*
Humans ; Neoplasms/therapy ; Probability ; Uncertainty
Czasopismo naukowe
Tytuł:
Multi-stage adaptive enrichment trial design with subgroup estimation.
Autorzy:
Joshi N; Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Nguyen C; Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Ivanova A; Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1038-1049. Date of Electronic Publication: 2020 Oct 18.
Typ publikacji:
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms:
Clinical Trials as Topic*
Research Design*
Humans ; Sample Size
Czasopismo naukowe
Tytuł:
Enhancing clarity of clinical trial safety reports for data monitoring committees.
Autorzy:
Thomas SM; Division of Biostatistics and Epidemiology, RTI International, Research Triangle Park, NC, USA.
Jung K; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Sun H; Division of Biometrics IV, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Psioda MA; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Quibrera PM; Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Strakowski SM; Department of Psychiatry, Dell Medical School, University of Texas, Austin, TX, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1147-1161. Date of Electronic Publication: 2020 Sep 08.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Clinical Trials Data Monitoring Committees*
Humans
Czasopismo naukowe
Tytuł:
A BAYESIAN ADAPTIVE TWO-STAGE DESIGN FOR PEDIATRIC CLINICAL TRIALS.
Autorzy:
Psioda MA; Department of Biostatistics, University of North Carolina, Chapel Hill, NC, USA.
Xue X; Center for Statistics of Drug Development, Data Science Safety and Regulatory, IQVIA Inc., Durham, NC, USA.
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2020 Nov 01; Vol. 30 (6), pp. 1091-1108. Date of Electronic Publication: 2020 Oct 05.
Typ publikacji:
Journal Article
MeSH Terms:
Clinical Trials as Topic*
Research Design*
Bayes Theorem ; Child ; Humans ; Sample Size
Czasopismo naukowe
Tytuł:
Optimal timing for interim analyses in clinical trials.
Autorzy:
Togo K; Clinical Statistics, Pfizer Japan, Inc., Tokyo, Japan. />Iwasaki M
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2013; Vol. 23 (5), pp. 1067-80.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Clinical Trials as Topic*/methods
Clinical Trials as Topic*/statistics & numerical data
Data Interpretation, Statistical*
Models, Statistical*
Endpoint Determination/*methods
Research Design/*statistics & numerical data
Early Termination of Clinical Trials ; Endpoint Determination/statistics & numerical data ; Humans ; Patient Selection ; Research Design/standards ; Sample Size ; Time Factors
Czasopismo naukowe
Tytuł:
Evaluation of early efficacy endpoints for proof-of-concept trials.
Autorzy:
Chen C; Merck & Co., Inc. , North Wales, PA 19454–1019, USA. Cong_ />Sun L
Li CL
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Źródło:
Journal of biopharmaceutical statistics [J Biopharm Stat] 2013 Mar 11; Vol. 23 (2), pp. 413-24.
Typ publikacji:
Journal Article
MeSH Terms:
Clinical Trials as Topic*
Drug Discovery*
Endpoint Determination*
Clinical Trials, Phase III as Topic ; Cost-Benefit Analysis ; Humans ; Neoplasms/drug therapy
Czasopismo naukowe

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