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Statistics in Biopharmaceutical Research
Journal Prestige (SJR): 1.187  Citation Impact (citeScore): 1 Number of Followers: 15  Subscription journalISSN (Print) 1946-6315 Published by American Statistical Association  [5 journals]
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- Statistical Innovation in Healthcare: Celebrating the Past 40 Years and
Looking Toward the Future–Special Issue for the 2021 Regulatory-Industry
Statistics Workshop-
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Authors: Bo HuangGene Pennelloa Global Biometrics; Drug Administration, Silver Spring, MD
Pages: 457 - 457
Abstract: Volume 15, Issue 3, July-September 2023, Page 457-457
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-08-02T06:41:22Z
DOI: 10.1080/19466315.2023.2224136
Issue No: Vol. 15, No. 3 (2023)
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- The Role of Statistical Thinking in Biopharmaceutical Research
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Authors: Frank BretzJoel B. Greenhousea Analytics; Novartis Pharma AG, Basel, Switzerlandb Center for Medical Data Science, Institute for Medical Statistics, Medical University of Vienna, Vienna, Austriac Department of Statistics & Data Science, Carnegie Mellon University, Pittsburgh, PA
Pages: 458 - 467
Abstract: Volume 15, Issue 3, July-September 2023, Page 458-467
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-24T01:16:50Z
DOI: 10.1080/19466315.2023.2224259
Issue No: Vol. 15, No. 3 (2023)
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- Statistical Considerations and Challenges for Pivotal Clinical Studies of
Artificial Intelligence Medical Tests for Widespread Use: Opportunities
for Inter-Disciplinary Collaboration-
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Authors: Arkendra Dea Agilent Technologies; Carpinteria, CAb Moderna Therapeutics, Cambridge, MA
Pages: 476 - 490
Abstract: Volume 15, Issue 3, July-September 2023, Page 476-490
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-14T04:16:39Z
DOI: 10.1080/19466315.2023.2169752
Issue No: Vol. 15, No. 3 (2023)
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- Beyond the Cox Hazard Ratio: A Targeted Learning Approach to Survival
Analysis in a Cardiovascular Outcome Trial Application-
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Authors: David ChenMaya L. PetersenHelene Charlotte RytgaardRandi GrønTheis LangeSøren RasmussenRichard E. PratleySteven P. MarsoKajsa KvistJohn BuseMark J. van der Laana Division of Biostatistics; UC Berkeley School of Public Health, Berkeley, CAb Section of Biostatistics, University of Copenhagen, Copenhagen, Denmarkc Novo Nordisk A/S, Søborg, Denmarkd AdventHealth Translational Research Institute, Orlando, FLe Midwest Heart Metabolism, UNC School of Medicine, Chapel Hill, NC
Pages: 524 - 539
Abstract: Volume 15, Issue 3, July-September 2023, Page 524-539
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-03T01:00:21Z
DOI: 10.1080/19466315.2023.2173644
Issue No: Vol. 15, No. 3 (2023)
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- What Can Be Achieved with the Estimand Framework'
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Authors: Susan MayoYongman KimDivision III; Office of Biostatistics, Office of Translational Science, Center for Drug Evaluation, Food Drug Administration, Silver Spring, MD
Pages: 549 - 553
Abstract: Volume 15, Issue 3, July-September 2023, Page 549-553
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-02T01:48:23Z
DOI: 10.1080/19466315.2023.2173645
Issue No: Vol. 15, No. 3 (2023)
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- From Logic-Respecting Efficacy Estimands to Logic-Ensuring Analysis
Principle for Time-to-Event Endpoint in Randomized Clinical Trials with
Subgroups-
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Authors: Yi LiuMiao YangSiyoen KilJiang LiShoubhik MondalYue ShentuHong TianLiwei WangGodwin Yunga Nektar Therapeutics, San Francisco, CAb LSK Global Pharma Services Co, Seoul, Koreac BeiGene, Ridgefield Park, NJd AstraZeneca, Gaithersburg, MDe Daiichi Sankyo Inc; Basking Ridge, NJg Genmab US, Inc, Princeton, NJh Genentech, South San Francisco, CA
Pages: 560 - 573
Abstract: Volume 15, Issue 3, July-September 2023, Page 560-573
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-18T06:29:01Z
DOI: 10.1080/19466315.2023.2186945
Issue No: Vol. 15, No. 3 (2023)
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- Experience with Advisory Committee Meeting Preparation and Execution
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Authors: Christine GauseJing ZhaoMerck & Co; Inc, Kenilworth, NJ
Pages: 574 - 581
Abstract: Volume 15, Issue 3, July-September 2023, Page 574-581
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-26T06:07:37Z
DOI: 10.1080/19466315.2023.2210079
Issue No: Vol. 15, No. 3 (2023)
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- Designing Dose-Optimization Studies in Cancer Drug Development:
Discussions with Regulators-
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Authors: Olga MarchenkoRajeshwari SridharaQi JiangElizabeth BarksdaleYuki AndoDinesh De AlwisKatie BrownLaura FernandesMark T. J. van BusselQiuyi ChooMichael CooryElizabeth Garrett-MayerThomas GwiseLorenzo HessRong LiuSumithra MandrekarDaniele OuelletJosé PinheiroMartin PoschNam Atiqur RahmanKhadija Rerhou RantellAndrew RavenSarem SaremSuman SenMirat ShahYuan Li ShenRichard SimonMarc TheoretYing YuanRichard Pazdura Bayer; Whippany, NJb Oncology Center of Excellence, US FDA, Silver Spring, MDc Seagen, Bothell, WAd LUNGevity Foundation, Chicago, ILe PMDA, Tokyo, Japanf Generate Biomedicines, Somerville, MAg Office of Biostatistics, Cder US Fda, Silver Spring, MDh Medicines Evaluation Board (MEB), Utrecht, The Netherlandsi HSA, Singapore, Singaporej Department of Health, Perth, Australiak American Society of Clinical Oncology (ASCO), Alexandria, VAl SMC, Bern, Switzerlandm Bristol Myers Squibb, Berkeley Heights, NJn Mayo Clinic, Rochester, MNo Janssen, Raritan, NJp Institute for Medical Statistics at the Medical University of Vienna, Vienna, Austriaq Office of Clinical Pharmacology, US Fda, Silver Spring, MDr Medicines Healthcare Products Regulatory Agency London, UKs Health Canada, Ottawa, Ontario, Canadat Novartis, East Hanover, NJu Office of Oncologic Diseases, Cder, US Fda, Silver Spring, MDv Simon Consulting, Seattle, WAw MD Anderson Cancer Center, Houston, TX
Pages: 697 - 703
Abstract: Volume 15, Issue 3, July-September 2023, Page 697-703
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Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-14T04:16:29Z
DOI: 10.1080/19466315.2023.2166099
Issue No: Vol. 15, No. 3 (2023)
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- Modified Robust Meta-Analytic-Predictive Priors for Incorporating
Historical Controls in Clinical Trials-
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Authors: Qiang ZhaoHaijun Maa Gilead Sciences Inc; Foster City, CAb Exelixis Inc, Alameda, CA
Pages: 1 - 7
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-09-15T07:38:36Z
DOI: 10.1080/19466315.2023.2241405
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- Enhancement of Basket Trial Designs with Incorporation of a Bayesian
Three-Outcome Decision-Making Framework-
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Authors: Gu MiYue YangZhumengmeng JinJi LinChristelle Lorenzatoa Biostatistics; Programming, Sanofi R&D, Vitry-sur-Seine, France
Pages: 1 - 12
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-09-13T07:32:41Z
DOI: 10.1080/19466315.2023.2241399
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- A Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design
with Efficacy Interim Analysis When Slope Is the Primary Endpoint-
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Authors: Qi ZhangYuqian ShenHui QuanPascal MininiLin Wanga Biostatistics; Programming, Sanofi, Bridgewater, NJb Biometrics, Insmed Incorporated, Bridgewater, NJ
Pages: 1 - 11
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-09-13T01:23:03Z
DOI: 10.1080/19466315.2023.2241398
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- A Comparison of Randomization Methods for Multi-Arm Clinical Trials
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Authors: Ruqayya A. AzherJames M. S. WasonMichael J. Graylinga Population Health Sciences Institute; Newcastle University, Newcastle upon Tyne, UKb Community Medicine Department, Umm Al-Qura University, Mecca, Saudi Arabia
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-08-29T01:02:56Z
DOI: 10.1080/19466315.2023.2238645
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- Statistical Inference for Vaccine Efficacy: A Re-Randomization Procedure
to Analyse Poisson Outcomes under Covariate-Adaptive Randomization-
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Authors: Leroy Jide OvbudeLuca GrassanoBrigitte CheuvartFrancesca Solmia GSK; Wavre, Belgiumb GSK, Siena, Italy
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-08-24T08:16:12Z
DOI: 10.1080/19466315.2023.2252150
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- Regulatory Guidance on Randomization and the Use of Randomization Tests in
Clinical Trials: A Systematic Review-
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Authors: Kerstine CarterAnnika L. ScheffoldJone RenteriaVance W. BergerYuqun Abigail LuoJonathan J. ChipmanOleksandr Sverdlova Therapeutic Area; Drug Administration, Silver Spring, MDf Huntsman Cancer Institute, University of Utah, University of Utah Health, Salt Lake City, UTg Early Development Analytics, Novartis Pharmaceuticals Corporation, East Hanover, NJ
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-08-15T06:32:20Z
DOI: 10.1080/19466315.2023.2239521
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- A Note on Stratification Errors in the Analysis of Clinical Trials
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Authors: Neal ThomasPfizer; Madison, CT
Pages: 1 - 9
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-27T07:15:17Z
DOI: 10.1080/19466315.2023.2241415
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- Statistical Considerations in Pediatric Cancer Trials: Report of American
Statistical Association Biopharmaceutical Section Open Forum Discussions-
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Authors: Rajeshwari SridharaOlga MarchenkoQi JiangElizabeth BarksdaleTodd A. AlonzoAnup AmatyaDavid AronsAlex BliuQiuyi ChooMichael CooryMartha DonoghueLori EhrlichLeonardo Fabio Costa FilhoElizabeth FoxBoris FreidlinNancy GoodmanDouglas S. HawkinsDieter A. HäringDominik KarresE. Anders KolbHelen MaoPallavi S. Mishra KalyaniArlene NaranjoAlberto PappoMartin PoschKaren PriceAndrew RavenKhadija Rerhou RantellLindsay RenfroDonna R. RiveraPourab RoyMinghua ShanRichard SimonSonia SinghMalcolm SmithMarc TheoretMarius ThomasZachary ThomasAndrew ThompsonHong TianYevgen TymofyeyevJonathon VallejoKyle WathenJingjing YeRichard PazdurGregory Reamana Oncology Center of Excellence US FDA; Silver Spring, MDb Bayer, Leverkusen, Germanyc Seagen, Bothell, WAd LUNGevity Foundation, Chicago, ILe Children’s Oncology Group (COG), Monrovia, CAf CDER US FDA, Silver Spring, MDg National Brain Tumor Society, Newton, MAh HC, Ottawa, Canadai HSA, Singapore, Singaporej TGA, Woden, Australiak ANVISA, Brasilia, Brazill St. Jude Children’s Hospital, Memphis, TNm NCI, NIH, Bethesda, MDn Kids V Cancer, Washington, DCo Novartis, Basel, Switzerlandp EMA, Amsterdam, Netherlandsq DuPont Hospital for Children, Wilmington, DEr University of Florida, Gainesville, FLs Institute for Medical Statistics at the Medical University of Vienna, Vienna, Austriat Eli Lilly, Indianapolis, INu MHRA, London, UKv Simon Consulting, Phoenix, AZw Beigene, Beijing, Chinax J&J, Titusville, NJy Cytel, Waltham, MA
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-25T12:21:10Z
DOI: 10.1080/19466315.2023.2238650
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- Which Randomization Methods Are Used Most Frequently in Clinical Trials'
Results of a Survey by the Randomization Working Group-
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Authors: Oleksandr SverdlovKerstine CarterRalf-Dieter HilgersColin C. EverettVance W. BergerYuqun Abigail LuoJonathan J. ChipmanYevgen RyeznikJennifer RossRuth KnightKazumi Yamadaa Early Development Analytics; Novartis Pharmaceuticals Corporation, East Hanover, NJ;b Therapeutic Area Drug Administration, Silver Spring, MD;g Huntsman Cancer Institute, University of Utah, University of Utah Health, Salt Lake City, UT;h AstraZeneca, Mölndal, Sweden;i Almac Group Ltd, Souderton, PA;j Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, Merseyside, UK;k Boehringer Ingelheim Corp USA, Ridgefield, CT
Pages: 1 - 15
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-11T02:10:46Z
DOI: 10.1080/19466315.2023.2225451
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- Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing
Average Bioequivalence-
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Authors: Marie Louise ØsterdalKyle RaymondChristian Bressen Pippera Department of Biostatistics; Leo Pharma A/S, Ballerup, Denmark;b Biostatistics OSCD & Outcomes 1, Novo Nordisk A/S, Soeborg, Denmark;c Department of Public Health, University of Southern Denmark, Odense, Denmark
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-11T02:07:27Z
DOI: 10.1080/19466315.2023.2223561
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- A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior
Borrowing-
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Authors: Jixian WangHongtao ZhangRam Tiwaria Bristol Myers Squibb; Boudry, Switzerland;b Biostatistics Research Decision Sciences, Merck & Co., Inc., North Wales, PA;c Bristol Myers Squibb, Berkeley Heights, NJ
Pages: 1 - 10
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-07-11T02:01:05Z
DOI: 10.1080/19466315.2023.2223533
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- A Novel Approach for Modeling Biphasic Dose–Response Curves
-
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Authors: Ya-Ching M. HsiehLeon ChangAlfred M. Barrona Pfizer Inc; La Jolla, CAb Janssen Research & Development, LLC, La Jolla, CA/Raritan, NJ
Pages: 1 - 11
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-06-30T01:53:43Z
DOI: 10.1080/19466315.2023.2207487
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- Vaccine Development during a Pandemic: General Lessons for Clinical Trial
Design-
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Authors: Benjamin HofnerElina AsikaniusWolfgang JacquetTheodor FramkeKatrien Oude RengerinkLukas Aguirre DávilaMaria GrünewaldFlorian KlinglmüllerMartin PoschFinbarr P. LeacyThomas LangArmin KochJörg ZinserlingKit Roesextraa Paul-Ehrlich-Institut; Langen, Germanyb Institute of Medical Informatics, Biometry, Medical Devices, Bonn, Germany n Radboud University Medical Center, Nijmegen, The Netherlands
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-06-28T12:44:20Z
DOI: 10.1080/19466315.2023.2211538
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- A Bayesian Adaptive Umbrella Trial Design with Robust Information
Borrowing for Screening Multiple Combination Therapies-
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Authors: Qing LiuWenxi YuLeiwen GaoXun JiangMichael WolfMay Moa Center for Design; Analysis, Amgen Inc., Thousand Oaks, CAb Department of Biostatistics, University of California, Los Angeles, CA
Pages: 1 - 11
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-06-26T07:18:27Z
DOI: 10.1080/19466315.2023.2215735
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- Coping with Information Loss and the Use of Auxiliary Sources of Data: A
Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial
Disruptions-
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Authors: Silvia CalderazzoSergey TarimaCarissa ReidNancy FlournoyTim FriedeNancy GellerJames L RosenbergerNigel StallardMoreno UrsinoMarc VandemeulebroeckeKelly Van LanckerSarah Zohara Division of Biostatistics; DKFZ (German Cancer Research Center), Heidelberg, Germanyb Division of Biostatistics, Medical College of Wisconsin, Wauwatosa, WIc University of Missouri, Columbia, MOd Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germanye DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germanyf National Heart, Lung, Statistics, Ghent University, Ghent, Belgium
Pages: 1 - 17
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-06-26T06:58:42Z
DOI: 10.1080/19466315.2023.2211023
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- Minimizing Selection Bias Under the Blackwell and Hodges Model with an
Equal Allocation Procedure in a Symmetric Allocation Space-
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Authors: Olga M. KuznetsovaLate Development Statistics, Merck & Co; Inc, Rahway, NJ
Pages: 1 - 8
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-06-02T07:05:50Z
DOI: 10.1080/19466315.2023.2208061
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- Application of Group Sequential Methods to the 2-in-1 Design and Its
Extensions for Interim Monitoring-
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Authors: Xuekui ZhangHaijun JiaLi XingCong Chena Department of Mathematics; Research Decision Sciences, Merck & Co., Inc., Rahway, NJ
Pages: 1 - 10
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-18T06:37:21Z
DOI: 10.1080/19466315.2023.2197402
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- Multiply Robust Weighted Generalized Estimating Equations for Incomplete
Longitudinal Binary Data Using Empirical Likelihood-
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Authors: Hiroshi KomazakiMasaaki DoiNaohiro YonemotoTosiya Satoa Department of Biostatistics; Kyoto University School of Public Health, Kyoto, Japanb Clinical Development Department, Maruho Co., Ltd, Kyoto, Japanc Data Science, Ono Pharmaceutical Co., Ltd., Osaka, Japand Department of Neuropsychopharmacology, National Center of Neurology Psychiatry, Tokyo, Japane Department of Public Health, Juntendo University School of Medicine, Bunkyo, Tokyo, Japan
Pages: 1 - 14
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-18T06:32:12Z
DOI: 10.1080/19466315.2023.2191990
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- Some Multiplicity Adjustment Procedures for Clinical Trials with
Sequential Design and Multiple Endpoints-
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Authors: Xiaodong LuoHui QuanBiostatistics; Programming, Sanofi US, Bridgewater, NJ
Pages: 1 - 12
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-14T12:35:04Z
DOI: 10.1080/19466315.2023.2191989
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- Copula-Based Model for Incorporating Single-Agent Historical Data into
Dual-Agent Phase I Cancer Trials-
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Authors: Koichi HashizumeJun TsuchidaTakashi Sozua Department of Information; Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan
Pages: 1 - 18
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-14T12:33:07Z
DOI: 10.1080/19466315.2023.2190932
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- Bayesian Borrowing Methods for Count Data: Analysis of Incontinence
Episodes in Patients with Overactive Bladder-
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Authors: Akalu BanbetaEmmanuel LesaffreReynaldo MartinaJoost van Rosmalena I-Biostat; UHasselt, Hasselt, Belgiumb Department of Statistics, Jimma University, Jimma, Ethiopiac I-Biostat, KU Leuven, Leuven, Belgiumd Faculty of Science, Technology, Engineering Mathematics, Open University, Milton Keynes, UKe Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlandsf Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands
Pages: 1 - 15
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-13T01:34:01Z
DOI: 10.1080/19466315.2023.2190933
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- Combining the Target Trial and Estimand Frameworks to Define the Causal
Estimand: An Application Using Real-World Data to Contextualize a
Single-Arm Trial-
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Authors: Lisa V. HampsonJufen ChuAiesha ZiaJie ZhangWei-Chun HsuCraig S. ParzynskiYanni HaoEvgeny Degtyareva Novartis Pharma AG; Basel, Switzerlandb Novartis Pharmaceuticals Corporation, East Hanover, NJc Genesis Research, Hoboken, NJ
Pages: 1 - 10
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-13T01:29:35Z
DOI: 10.1080/19466315.2023.2190931
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- A Test of the Dependence Assumptions for the Simes-Test-based Multiple
Test Procedures-
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Authors: Jiangtao GouDepartment of Mathematics; Statistics, Villanova University, Villanova, PA
Pages: 1 - 7
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-13T01:25:42Z
DOI: 10.1080/19466315.2023.2190930
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- Adaptive Endpoints Selection with Application in Rare Disease
-
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Authors: Heng XuYi LiuRobert A. Beckmana Nektar Therapeutics; San Francisco, CAb Departments of Oncology Innovation Center for Biomedical Informatics, Georgetown University Medical Center, Washington, DC
Pages: 1 - 9
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-04-07T07:48:40Z
DOI: 10.1080/19466315.2023.2183252
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- Examples of Applying RWE Causal-Inference Roadmap to Clinical Studies
-
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Authors: Martin HoSusan GruberYixin FangDouglas E. FarisPallavi Mishra-KalyaniDavid BenkeserMark van der Laana Google; LLC, Mountain View, CAb Putnam Data Sciences, LLC, Boston, MAc AbbVie, North Chicago, ILd Eli Lilly Company, Indianapolis, INe FDA CDER, Silver Spring, MDf Biostatistics, Emory University, Atlanta, GAg Biostatistics, University of California, Berkeley, CA
Pages: 1 - 14
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-21T12:32:34Z
DOI: 10.1080/19466315.2023.2177333
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- Targeted Learning: Toward a Future Informed by Real-World Evidence
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Authors: Susan GruberRachael V. PhillipsHana LeeMartin HoJohn ConcatoMark J. van der Laana Putnam Data Sciences; LLC, Cambridge, MAb Department of Biostatistics, School of Public Health, University of California at Berkeley, Berkeley, CAc Office of Biostatistics, Center for Drug Evaluation Drug Administration, Silver Spring, MD
Pages: 1 - 15
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-15T01:31:34Z
DOI: 10.1080/19466315.2023.2182356
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- Methods for Informative Censoring in Time-to-Event Data Analysis
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Authors: Man JinYixin FangData; Statistical Sciences, AbbVie Inc., North Chicago, IL
Pages: 1 - 8
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-15T01:25:29Z
DOI: 10.1080/19466315.2023.2182355
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- Joint Analysis of Longitudinal Data and Zero-Inflated Recurrent Events
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Authors: Chenchen MaKimberly CriminStatistics; Data Company, Indianapolis, IN
Pages: 1 - 7
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-10T07:08:05Z
DOI: 10.1080/19466315.2023.2177726
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- Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in
Oncology—Dynamic Monitoring and More Flexibility-
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Authors: Weichung Joe ShihYunqi ZhaoTai Xiea Department of Biostatistics; Quantitative Sciences, Takeda Pharmaceuticals, Cambridge, MAc CIMS Global, Somerset, NJ
Pages: 1 - 7
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-03-10T07:07:06Z
DOI: 10.1080/19466315.2023.2177332
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- An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response
Adaptive, Randomized Trial-
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Authors: Jonathan BeallJordan ElmJames ChamberlainEric RosenthalJaideep KapurValerie Durkalski-Mauldina Department of Public Health Sciences; Medical University of South Carolina, Charleston, SCb Division of Emergency Medicine, Children’s National Hospital, Washington, DCc Department of Neurology, Massachusetts General Hospital, Boston, MAd Department of Neurology, UVA Health, Charlottesville, VA
Pages: 1 - 6
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-24T08:24:32Z
DOI: 10.1080/19466315.2023.2169344
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- Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types
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Authors: Tuo WangRachel ZilinskasYing LiYongming Qua Department of Biostatistics; Company, Indianapolis, IN
Pages: 1 - 12
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-14T04:28:49Z
DOI: 10.1080/19466315.2023.2169753
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- Assessing the Commonly Used Assumptions in Estimating the Principal Causal
Effect in Clinical Trials-
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Authors: Yongming QuIlya LipkovichStephen J. Ruberga Department of Global Statistical Sciences; Eli Lilly Company, Indianapolis, IN; b Analytix Thinking, LCC, Indianapolis, IN
Pages: 1 - 18
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-14T04:16:36Z
DOI: 10.1080/19466315.2023.2166097
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- A Flexible Analytical Framework for Reference-Based Imputation, Delta
Adjustment and Tipping-Point Stress-Testing-
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Authors: Alberto García-HernandezTeresa PérezMaría del Carmen PardoDimitris Rizopoulosa Facultad de Estudios Estadísticos; Univ. Complutense, Madrid, Spainb Facultad de Ciencias Matemáticas, Univ. Complutense, Madrid, Spainc Erasmus Medical Center, Rotterdam, The Netherlands
Pages: 1 - 13
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-02T07:42:44Z
DOI: 10.1080/19466315.2022.2151506
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- A Closer Look at the Kernels Generated by the Decision and Regression Tree
Ensembles-
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Authors: Dai FengRichard Baumgartnera Data; Statistical Sciences, AbbVie Inc., North Chicago, ILb Biometrics Research, Merck & Co., Inc., Kenilworth, NJ
Pages: 1 - 16
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-02-02T07:22:39Z
DOI: 10.1080/19466315.2022.2150680
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- A Modification of Location Commensurate Power Prior in Clinical Trials
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Authors: Hong TranMAS/TMEDS; Janssen Pharmaceuticals, Spring House, PA
Pages: 1 - 8
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-01-06T03:19:22Z
DOI: 10.1080/19466315.2022.2152485
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- The Targeted Virtual Control Approach for Single-Arm Clinical Trials with
External Controls-
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Authors: Yixin FangSheng ZhongDepartment of Data; Statistical Sciences, AbbVie Inc., North Chicago, IL
Pages: 1 - 10
Abstract: .
Citation: Statistics in Biopharmaceutical Research
PubDate: 2023-01-05T01:42:22Z
DOI: 10.1080/19466315.2022.2154260
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