The Role of Statistics in Regulatory Decision Making

Type: Article

Publication Date: 2013-12-30

Citations: 20

DOI: https://doi.org/10.1177/2168479013514418

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Locations

  • Therapeutic Innovation & Regulatory Science - View
  • PubMed - View

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+ Making what’s advanced today routine tomorrow 2015 Stephen J. Ruberg
+ PDF Chat Estimation of treatment effects in short‐term depression studies. An evaluation based on the <scp>ICH E9</scp>(<scp>R1</scp>) estimands framework 2022 Marian Mitroiu
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+ Methods for efficacy evaluations of antibacterial treatments in multiple body-site infection trials 2016 Mohammad F. Huque
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+ Authors' response to comments 2016 PĂ©ter Bauer
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+ Properties of adaptive clinical trial signature design in the presence of gene and gene-treatment interaction 2017 A. Cambon
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+ Biostatistics in Clinical Trials 2020 Olga Marchenko
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+ PDF Chat The Role of Expert Judgment in Statistical Inference and Evidence-Based Decision-Making 2019 Naomi C. Brownstein
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+ Discussion on “Improving precision and power in randomized trials for COVID‐19 treatments using covariate adjustment, for binary, ordinal, and time‐to‐event outcomes” by David Benkeser, Ivan Diaz, Alex Luedtke, Jodi Segal, Daniel Scharfstein, and Michael Rosenblum 2021 Lisa M. LaVange
+ Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance 2014 Mohammad F. Huque
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+ Commentary on “Statistics at FDA: Reflections on the Past Six Years” 2019 Olga Marchenko
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+ Consistency ensured test strategies for supportive evidence of treatment efficacy in noninferiority clinical trials 2017 Mohammad F. Huque
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Citing (15)

Action Title Year Authors
+ Encyclopedia of Biopharmaceutical Statistics 2010 Shein‐Chung Chow
+ BIOPHARMACEUTICAL STATISTICS IN A PHARMACEUTICAL REGULATED ENVIRONMENT: PAST, PRESENT, AND FUTURE 2001 Anthony C. Segreti
Hoi M. Leung
Gary G. Koch
Robert L. Davis
Noel R. Mohberg
Karl E. Peace
+ Similarities and Differences of Bayesian Designs and Adaptive Designs for Medical Devices: A Regulatory View 2013 Gregory Campbell
+ PDF Chat Adaptive adjustment of the randomization ratio using historical control data 2013 Brian P. Hobbs
Bradley P. Carlin
Daniel J. Sargent
+ PDF Chat The Prevention and Treatment of Missing Data in Clinical Trials 2012 Roderick J. A. Little
Ralph B. D’Agostino
Michael L. Cohen
Kay Dickersin
Scott S. Emerson
John T. Farrar
Constantine Frangakis
Joseph W. Hogan
Geert Molenberghs
Susan A. Murphy
+ PDF Chat Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies 2010 Christy Chuang‐Stein
Mohan Beltangady
+ Bayesian approach to the design and analysis of non‐inferiority trials for anti‐infective products 2013 Meg A. Gamalo
Ram C. Tiwari
Lisa M. LaVange
+ Bayesian Statistics in Medical Devices: Innovation Sparked by the FDA 2011 Gregory Campbell
+ Bayesian Approach for Clinical Trial Safety Data Using an Ising Prior 2013 Bradley McEvoy
Rajesh Nandy
Ram C. Tiwari
+ Multiplicity in Regulatory Statistical Review 2013 Thomas Permutt
+ A statistical approach to central monitoring of data quality in clinical trials 2012 David Venet
Erik Doffagne
Tomasz Burzykowski
F. Beckers
Yves Tellier
Eric Genevois-Marlin
Ursula Becker
Valerie BĂ©e
VĂ©ronique Wilson
Catherine Legrand
+ PDF Chat The Prevention and Treatment of Missing Data in Clinical Trials 2010 National Research Council
+ P-Values, Evidence, and Multiplicity Considerations for Controlled Clinical Trials 2010 Mohammad F. Huque
Mohamed Alosh
Satya D. Dubey
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+ Career success training for statisticians: a progress update 2012 Robert M. Rodriguez
+ P-Values, Evidence and Multiplicity Considerations for Controlled Clinical Trials 2003 Mohammad F. Huque
Mohamed Alosh
S. D. Dubey