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Principles and Practice of Clinical Trials
Edited by Steven Piantadosi () and
Curtis L. Meinert ()
in Springer Books from Springer
Date: 2022
ISBN: 978-3-319-52636-2
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Chapters in this book: - Ch 1 Social and Scientific History of Randomized Controlled Trials
- Laura E. Bothwell, Wen-Hua Kuo, David S. Jones and Scott H. Podolsky
- Ch 2 Evolution of Clinical Trials Science
- Steven Piantadosi
- Ch 3 Terminology: Conventions and Recommendations
- Curtis L. Meinert
- Ch 4 Clinical Trials, Ethics, and Human Protections Policies
- Jonathan Kimmelman
- Ch 5 History of the Society for Clinical Trials
- O. Dale Williams and Barbara S. Hawkins
- Ch 6 Investigator Responsibilities
- Bruce J. Giantonio
- Ch 7 Centers Participating in Multicenter Trials
- Roberta W. Scherer and Barbara S. Hawkins
- Ch 8 Qualifications of the Research Staff
- Catherine A. Meldrum
- Ch 9 Multicenter and Network Trials
- Sheriza Baksh
- Ch 10 Principles of Protocol Development
- Bingshu E. Chen, Alison Urton, Anna Sadura and Wendy R. Parulekar
- Ch 11 Procurement and Distribution of Study Medicines
- Eric Hardter, Julia Collins, Dikla Shmueli-Blumberg and Gillian Armstrong
- Ch 12 Selection of Study Centers and Investigators
- Dikla Shmueli-Blumberg, Maria Figueroa and Carolyn Burke
- Ch 13 Design and Development of the Study Data System
- Steve Canham
- Ch 14 Implementing the Trial Protocol
- Jamie B. Oughton and Amanda Lilley-Kelly
- Ch 15 Participant Recruitment, Screening, and Enrollment
- Pascale Wermuth
- Ch 16 Administration of Study Treatments and Participant Follow-Up
- Jennifer J. Gassman
- Ch 17 Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials
- Kristin Knust, Lauren Yesko, Ashley Case and Kate Bickett
- Ch 18 End of Trial and Close Out of Data Collection
- Gillian Booth
- Ch 19 International Trials
- Lynette Blacher and Linda Marillo
- Ch 20 Documentation: Essential Documents and Standard Operating Procedures
- Eleanor McFadden, Julie Jackson and Jane Forrest
- Ch 21 Consent Forms and Procedures
- Ann-Margret Ervin and Joan B. Cobb Pettit
- Ch 22 Contracts and Budgets
- Eric Riley and Eleanor McFadden
- Ch 23 Long-Term Management of Data and Secondary Use
- Steve Canham
- Ch 24 Regulatory Requirements in Clinical Trials
- Michelle Pernice and Alan Colley
- Ch 25 ClinicalTrials.gov
- Gillian Gresham
- Ch 26 Funding Models and Proposals
- Matthew Westmore and Katie Meadmore
- Ch 27 Financial Compliance in Clinical Trials
- Barbara K. Martin
- Ch 28 Financial Conflicts of Interest in Clinical Trials
- Julie D. Gottlieb
- Ch 29 Trial Organization and Governance
- O. Dale Williams and Katrina Epnere
- Ch 30 Advocacy and Patient Involvement in Clinical Trials
- Ellen Sigal, Mark Stewart and Diana Merino
- Ch 31 Training the Investigatorship
- Claire Weber
- Ch 32 Responsibilities and Management of the Clinical Coordinating Center
- Trinidad Ajazi
- Ch 33 Efficient Management of a Publicly Funded Cancer Clinical Trials Portfolio
- Catherine Tangen and Michael LeBlanc
- Ch 34 Archiving Records and Materials
- Winifred Werther and Curtis L. Meinert
- Ch 35 Good Clinical Practice
- Claire Weber
- Ch 36 Institutional Review Boards and Ethics Committees
- Keren R. Dunn
- Ch 37 Data and Safety Monitoring and Reporting
- Sheriza Baksh and Lijuan Zeng
- Ch 38 Post-Approval Regulatory Requirements
- Winifred Werther and Anita M. Loughlin
- Ch 39 Controlling for Multiplicity, Eligibility, and Exclusions
- Amber Salter and J. Philip Miller
- Ch 40 Principles of Clinical Trials: Bias and Precision Control
- Fan-fan Yu
- Ch 41 Power and Sample Size
- Elizabeth Garrett-Mayer
- Ch 42 Controlling Bias in Randomized Clinical Trials
- Bruce A. Barton
- Ch 43 Masking of Trial Investigators
- George Howard and Jenifer H. Voeks
- Ch 44 Masking Study Participants
- Lea Drye
- Ch 45 Issues for Masked Data Monitoring
- O. Dale Williams and Katrina Epnere
- Ch 46 Variance Control Procedures
- Heidi L. Weiss, Jianrong Wu, Katrina Epnere and O. Dale Williams
- Ch 47 Ascertainment and Classification of Outcomes
- Wayne Rosamond and David Couper
- Ch 48 Bias Control in Randomized Controlled Clinical Trials
- Diane Uschner and William F. Rosenberger
- Ch 49 Use of Historical Data in Design
- Christopher Kim, Victoria Chia and Michael Kelsh
- Ch 50 Outcomes in Clinical Trials
- Justin M. Leach, Inmaculada Aban and Gary R. Cutter
- Ch 51 Patient-Reported Outcomes
- Gillian Gresham and Patricia A. Ganz
- Ch 52 Translational Clinical Trials
- Steven Piantadosi
- Ch 53 Dose-Finding and Dose-Ranging Studies
- Mark R. Conaway and Gina R. Petroni
- Ch 54 Inferential Frameworks for Clinical Trials
- James P. Long and J. Jack Lee
- Ch 55 Dose Finding for Drug Combinations
- Mourad Tighiouart
- Ch 56 Middle Development Trials
- Emine O. Bayman
- Ch 57 Randomized Selection Designs
- Shing M. Lee, Bruce Levin and Cheng-Shiun Leu
- Ch 58 Futility Designs
- Sharon D. Yeatts and Yuko Y. Palesch
- Ch 59 Interim Analysis in Clinical Trials
- John A. Kairalla, Rachel Zahigian and Samuel S. Wu
- Ch 60 Bayesian Adaptive Designs for Phase I Trials
- Michael J. Sweeting, Adrian P. Mander and Graham M. Wheeler
- Ch 61 Adaptive Phase II Trials
- Boris Freidlin and Edward L. Korn
- Ch 62 Biomarker-Guided Trials
- L. C. Brown, A. L. Jorgensen, M. Antoniou and J. Wason
- Ch 63 Diagnostic Trials
- Madhu Mazumdar, Xiaobo Zhong and Bart Ferket
- Ch 64 Designs to Detect Disease Modification
- Michael P. McDermott
- Ch 65 Screening Trials
- Philip C. Prorok
- Ch 66 Biosimilar Drug Development
- Johanna Mielke and Byron Jones
- Ch 67 Prevention Trials: Challenges in Design, Analysis, and Interpretation of Prevention Trials
- Shu Jiang and Graham A. Colditz
- Ch 68 N-of-1 Randomized Trials
- Reza D. Mirza, Sunita Vohra, Richard Kravitz and Gordon H. Guyatt
- Ch 69 Noninferiority Trials
- Patrick P. J. Phillips and David V. Glidden
- Ch 70 Cross-over Trials
- Byron Jones
- Ch 71 Factorial Trials
- Steven Piantadosi and Susan Halabi
- Ch 72 Within Person Randomized Trials
- Gui-Shuang Ying
- Ch 73 Device Trials
- Heng Li, Pamela E. Scott and Lilly Q. Yue
- Ch 74 Complex Intervention Trials
- Linda Sharples and Olympia Papachristofi
- Ch 75 Randomized Discontinuation Trials
- Valerii V. Fedorov
- Ch 76 Platform Trial Designs
- Oleksandr Sverdlov, Ekkehard Glimm and Peter Mesenbrink
- Ch 77 Cluster Randomized Trials
- Lawrence H. Moulton and Richard J. Hayes
- Ch 78 Multi-arm Multi-stage (MAMS) Platform Randomized Clinical Trials
- Babak Choodari-Oskooei, Matthew R. Sydes, Patrick Royston and Mahesh K. B. Parmar
- Ch 79 Sequential, Multiple Assignment, Randomized Trials (SMART)
- Nicholas J. Seewald, Olivia Hackworth and Daniel Almirall
- Ch 80 Monte Carlo Simulation for Trial Design Tool
- Suresh Ankolekar, Cyrus Mehta, Rajat Mukherjee, Sam Hsiao, Jennifer Smith and Tarek Haddad
- Ch 81 Preview of Counting and Analysis Principles
- Nancy L. Geller
- Ch 82 Intention to Treat and Alternative Approaches
- Judith D. Goldberg
- Ch 83 Estimation and Hypothesis Testing
- Pamela A. Shaw and Michael A. Proschan
- Ch 84 Estimands and Sensitivity Analyses
- Estelle Russek-Cohen and David Petullo
- Ch 85 Confident Statistical Inference with Multiple Outcomes, Subgroups, and Other Issues of Multiplicity
- Siyoen Kil, Eloise Kaizar, Szu-Yu Tang and Jason C. Hsu
- Ch 86 Missing Data
- Guangyu Tong, Fan Li and Andrew S. Allen
- Ch 87 Essential Statistical Tests
- Gregory R. Pond and Samantha-Jo Caetano
- Ch 88 Nonparametric Survival Analysis
- Yuliya Lokhnygina
- Ch 89 Survival Analysis II
- James J. Dignam
- Ch 90 Prognostic Factor Analyses
- Liang Li
- Ch 91 Logistic Regression and Related Methods
- Márcio A. Diniz and Tiago M. Magalhães
- Ch 92 Statistical Analysis of Patient-Reported Outcomes in Clinical Trials
- Gina L. Mazza and Amylou C. Dueck
- Ch 93 Adherence Adjusted Estimates in Randomized Clinical Trials
- Sreelatha Meleth
- Ch 94 Randomization and Permutation Tests
- Vance W. Berger, Patrick Onghena and J. Rosser Matthews
- Ch 95 Generalized Pairwise Comparisons for Prioritized Outcomes
- Marc Buyse and Julien Peron
- Ch 96 Use of Resampling Procedures to Investigate Issues of Model Building and Its Stability
- Willi Sauerbrei and Anne-Laure Boulesteix
- Ch 97 Joint Analysis of Longitudinal and Time-to-Event Data
- Zheng Lu, Emmanuel Chigutsa and Xiao Tong
- Ch 98 Pharmacokinetic and Pharmacodynamic Modeling
- Shamir N. Kalaria, Hechuan Wang and Jogarao V. Gobburu
- Ch 99 Safety and Risk Benefit Analyses
- Jeff Jianfei Guo
- Ch 100 Causal Inference: Efficacy and Mechanism Evaluation
- Sabine Landau and Richard Emsley
- Ch 101 Development and Validation of Risk Prediction Models
- Damien Drubay, Ben Van Calster and Stefan Michiels
- Ch 102 Paper Writing
- Curtis L. Meinert
- Ch 103 Reporting Biases
- S. Swaroop Vedula, Asbjørn Hróbjartsson and Matthew J. Page
- Ch 104 CONSORT and Its Extensions for Reporting Clinical Trials
- Sally Hopewell, Isabelle Boutron and David Moher
- Ch 105 Publications from Clinical Trials
- Barbara S. Hawkins
- Ch 106 Study Name, Authorship, Titling, and Credits
- Curtis L. Meinert
- Ch 107 De-identifying Clinical Trial Data
- Jimmy Le
- Ch 108 Data Sharing and Reuse
- Ida Sim
- Ch 109 Introduction to Systematic Reviews
- Tianjing Li, Ian J. Saldanha and Karen A. Robinson
- Ch 110 Introduction to Meta-Analysis
- Theodoros Evrenoglou, Silvia Metelli and Anna Chaimani
- Ch 111 Reading and Interpreting the Literature on Randomized Controlled Trials
- Janet Wittes
- Ch 112 Trials Can Inform or Misinform: “The Story of Vitamin A Deficiency and Childhood Mortality”
- Alfred Sommer
- Ch 113 Issues in Generalizing Results from Clinical Trials
- Steven Piantadosi
- Ch 114 Leveraging “Big Data” for the Design and Execution of Clinical Trials
- Stephen J. Greene, Marc D. Samsky and Adrian F. Hernandez
- Ch 115 Trials in Complementary and Integrative Health Interventions
- Catherine M. Meyers and Qilu Yu
- Ch 116 Orphan Drugs and Rare Diseases
- James E. Valentine and Frank J. Sasinowski
- Ch 117 Pragmatic Randomized Trials Using Claims or Electronic Health Record Data
- Frank W. Rockhold and Benjamin A. Goldstein
- Ch 118 Fraud in Clinical Trials
- Stephen L. George, Marc Buyse and Steven Piantadosi
- Ch 119 Clinical Trials on Trial: Lawsuits Stemming from Clinical Research
- John J. DeBoy and Annie X. Wang
- Ch 120 Biomarker-Driven Adaptive Phase III Clinical Trials
- Richard Simon
- Ch 121 Clinical Trials in Children
- Gail D. Pearson, Kristin M. Burns and Victoria L. Pemberton
- Ch 122 Trials in Older Adults
- Sergei Romashkan and Laurie Ryan
- Ch 123 Trials in Minority Populations
- Otis W. Brawley
- Ch 124 Expanded Access to Drug and Device Products for Clinical Treatment
- Tracy Ziolek, Jessica L. Yoos, Inna Strakovsky, Praharsh Shah and Emily Robison
- Ch 125 A Perspective on the Process of Designing and Conducting Clinical Trials
- Curtis L. Meinert and Steven Piantadosi
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http://www.springer.com/9783319526362 DOI: 10.1007/978-3-319-52636-2
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