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Biopharmaceutical applied statistics symposium. Volume 1, Design of clinical trials / Karl E. Peace, Ding-Geng Chen, Sandeep Menon, editors.

Singapore : Springer, [2018].

Online access

  • Title:
    Biopharmaceutical applied statistics symposium. Volume 1, Design of clinical trials / Karl E. Peace, Ding-Geng Chen, Sandeep Menon, editors.
  • Contributor: Karl E. Peace 1941- editor.;
    Ding-Geng Chen editor.;
    Sandeep M. Menon editor.
  • Other Titles: Variant Title: Design of clinical trials
  • Subjects: Statistics; Drugs -- Testing -- Statistical methods -- Congresses; Biopharmaceutics -- Congresses; MEDICAL / Surgery / General; Statistics; Statistics for Life Sciences, Medicine, Health Sciences; Biostatistics; Biopharmaceutics; Drugs -- Testing -- Statistical methods; Science -- Life Sciences -- General; Life sciences: general issues; Statistical methods; Medical -- Biostatistics; Probability & statistics; Electronic books; Conference papers and proceedings;
    Dewey: 617.040287
  • Rights: Terms governing use: Copyright.
    Access restrictions: NON_PRINT_LEGAL_DEPOSIT
  • Publication Details: Singapore : Springer, [2018].
  • Language: English
  • Description: Contents: Intro; Preface; Contents; Editors and Contributors; 1 A Statistical Approach to Clinical Trial Simulations; 1.1 Introduction; 1.2 Protocol Deviations; 1.2.1 Noncompliance; 1.2.2 Dropouts and Missing Data; 1.3 Methods; 1.4 The Clinical Trial Simulation System; 1.5 Some Published Clinical Trial Simulations; 1.6 Commercially Available Trial Design Software Packages; 1.7 Discussion; References; 2 Choosing the Function of Baseline Run-in Data for Use as a Covariate in the Analysis of Treatment Data from Phase III Clinical Trials in Hypertension; 2.1 Introduction; 2.2 Literature Review; 2.3 Theory
    Contents: 2.4 Patterns of Data2.4.1 Baseline Run-in, Pre-randomization Period; 2.4.2 Post Randomization Treatment Period; 2.5 Simulation; 2.5.1 Ranges and Size of the Cohort Over Baseline Run-in; 2.5.2 Baseline Run-in, Pre-randomization Period; 2.5.3 Post Randomization Treatment Period; 2.5.4 Data Simulation Process; 2.6 Statistical Assessment of Covariates; 2.6.1 Models Considered; 2.6.2 Analysis Strategy; 2.6.3 Analysis Results; 2.7 Conclusions; Appendix; References; 3 Adaptive Trial Design in Clinical Research; 3.1 Introduction; 3.2 What Is Adaptive Design?; 3.2.1 Adaptations
    Contents: 3.2.2 Type of Adaptive Designs3.2.3 Regulatory/Statistical Perspectives; 3.3 Impact of Protocol Amendments; 3.3.1 Moving Target Patient Population; 3.3.2 Statistical Inference with Covariate Adjustment; 3.3.3 Inference Based on Mixture Distribution; 3.4 Challenges in by Design Adaptations; 3.4.1 Adaptive Group Sequential Design; 3.4.2 Adaptive Dose Finding Design; 3.4.3 Adaptive Seamless Designs; 3.5 Obstacles of Retrospective Adaptations; 3.6 Concluding Remarks; References; 4 Best Practices in Clinical Trial Simulations for Adaptive Study Designs; 4.1 Introduction; 4.2 Motivation
    Contents: 4.3 Simulation Process4.3.1 Simulation Terminology; 4.3.2 Analysis Models and Assumptions; 4.3.3 Simulation Model; 4.3.4 Performance Metrics; 4.4 Scenario Planning; 4.5 Testing; 4.6 Benefits and Challenges; 4.7 Conclusions; References; 5 Designing and Analyzing Recurrent Event Data Trials; 5.1 Introduction; 5.2 Methods; 5.2.1 Time to First Event; 5.2.2 Multiple Events Per Subject; 5.2.3 Poisson Regression; 5.2.4 Negative Binomial Regression; 5.2.5 Extended Cox Models for Recurrent Events; 5.3 Illustrations; 5.3.1 Poisson Regression Data (N = 1000); 5.3.2 Poisson Regression Data (N = 25, 000)
    Contents: 5.3.3 Negative Binomial Regression (N = 25, 000)5.3.4 Comparing Estimates and Standard Errors; 5.3.5 Goodness of Fit; 5.3.6 Simulations; 5.4 Discussion; References; 6 Response-Adaptive Allocation for Binary Outcomes: Bayesian Methods from the BASS Conference; 6.1 Introduction; 6.2 Response-Adaptive Allocation; 6.2.1 Optimal Allocation; 6.2.2 Natural Lead-In; 6.3 General Bayesian Approach; 6.3.1 Posterior Estimates and Probabilities; 6.4 Example 1: The Decreasingly Informative Prior Approach; 6.4.1 Decreasingly-Informative Prior Model; 6.4.2 Simulation Study for DIP Model
  • Identifier: ISBN 9789811078293 (electronic bk.); ISBN 9811078297 (electronic bk.)
    10.1007/978-981-10-7829-3 doi; BNB GBB8J9114; System number: 019097422
  • Physical Description: 1 online resource.
  • Series: ICSA book series in statistics,
  • Shelfmark(s): General Reference Collection DRT ELD.DS.342789
  • UIN: BLL01019097422

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