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Principles and Practice of Clinical Trials
Editor
Listed:
- Steven Piantadosi(Brigham and Women’s Hospital, Harvard Medical School, Department of Surgery, Division of Surgical Oncology)Curtis L. Meinert(Johns Hopkins University, Department of Epidemiology, School of Public Health)
Abstract
No abstract is available for this item.
Individual chapters are listed in the "Chapters" tab
Suggested Citation
DOI: 10.1007/978-3-319-52636-2
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Book Chapters
The following chapters of this book are listed in IDEAS- Bruce J. Giantonio, 2022. "Investigator Responsibilities," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 6, pages 85-95, Springer.
- Roberta W. Scherer & Barbara S. Hawkins, 2022. "Centers Participating in Multicenter Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 7, pages 97-121, Springer.
- Bingshu E. Chen & Alison Urton & Anna Sadura & Wendy R. Parulekar, 2022. "Principles of Protocol Development," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 10, pages 151-168, Springer.
- Eric Hardter & Julia Collins & Dikla Shmueli-Blumberg & Gillian Armstrong, 2022. "Procurement and Distribution of Study Medicines," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 11, pages 169-189, Springer.
- Dikla Shmueli-Blumberg & Maria Figueroa & Carolyn Burke, 2022. "Selection of Study Centers and Investigators," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 12, pages 191-207, Springer.
- Steve Canham, 2022. "Design and Development of the Study Data System," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 13, pages 209-237, Springer.
- Jamie B. Oughton & Amanda Lilley-Kelly, 2022. "Implementing the Trial Protocol," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 14, pages 239-255, Springer.
- Pascale Wermuth, 2022. "Participant Recruitment, Screening, and Enrollment," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 15, pages 257-278, Springer.
- Jennifer J. Gassman, 2022. "Administration of Study Treatments and Participant Follow-Up," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 16, pages 279-302, Springer.
- Kristin Knust & Lauren Yesko & Ashley Case & Kate Bickett, 2022. "Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 17, pages 303-320, Springer.
- Gillian Booth, 2022. "End of Trial and Close Out of Data Collection," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 18, pages 321-346, Springer.
- Lynette Blacher & Linda Marillo, 2022. "International Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 19, pages 347-368, Springer.
- Eleanor McFadden & Julie Jackson & Jane Forrest, 2022. "Documentation: Essential Documents and Standard Operating Procedures," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 20, pages 369-387, Springer.
- Ann-Margret Ervin & Joan B. Cobb Pettit, 2022. "Consent Forms and Procedures," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 21, pages 389-410, Springer.
- Eric Riley & Eleanor McFadden, 2022. "Contracts and Budgets," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 22, pages 411-425, Springer.
- Michelle Pernice & Alan Colley, 2022. "Regulatory Requirements in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 24, pages 459-478, Springer.
- Matthew Westmore & Katie Meadmore, 2022. "Funding Models and Proposals," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 26, pages 497-519, Springer.
- O. Dale Williams & Katrina Epnere, 2022. "Trial Organization and Governance," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 29, pages 559-568, Springer.
- Ellen Sigal & Mark Stewart & Diana Merino, 2022. "Advocacy and Patient Involvement in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 30, pages 569-581, Springer.
- Catherine Tangen & Michael LeBlanc, 2022. "Efficient Management of a Publicly Funded Cancer Clinical Trials Portfolio," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 33, pages 615-636, Springer.
- Winifred Werther & Curtis L. Meinert, 2022. "Archiving Records and Materials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 34, pages 637-648, Springer.
- Claire Weber, 2022. "Good Clinical Practice," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 35, pages 649-656, Springer.
- Keren R. Dunn, 2022. "Institutional Review Boards and Ethics Committees," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 36, pages 657-678, Springer.
- Christopher Kim & Victoria Chia & Michael Kelsh, 2022. "Use of Historical Data in Design," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 49, pages 877-890, Springer.
- Justin M. Leach & Inmaculada Aban & Gary R. Cutter, 2022. "Outcomes in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 50, pages 891-914, Springer.
- Steven Piantadosi, 2022. "Translational Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 52, pages 939-950, Springer.
- Mark R. Conaway & Gina R. Petroni, 2022. "Dose-Finding and Dose-Ranging Studies," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 53, pages 951-971, Springer.
- Mourad Tighiouart, 2022. "Dose Finding for Drug Combinations," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 55, pages 1003-1030, Springer.
- Emine O. Bayman, 2022. "Middle Development Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 56, pages 1031-1045, Springer.
- Shing M. Lee & Bruce Levin & Cheng-Shiun Leu, 2022. "Randomized Selection Designs," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 57, pages 1047-1066, Springer.
- Sharon D. Yeatts & Yuko Y. Palesch, 2022. "Futility Designs," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 58, pages 1067-1082, Springer.
- John A. Kairalla & Rachel Zahigian & Samuel S. Wu, 2022. "Interim Analysis in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 59, pages 1083-1102, Springer.
- Michael J. Sweeting & Adrian P. Mander & Graham M. Wheeler, 2022. "Bayesian Adaptive Designs for Phase I Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 60, pages 1105-1131, Springer.
- Michael P. McDermott, 2022. "Designs to Detect Disease Modification," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 64, pages 1199-1218, Springer.
- Philip C. Prorok, 2022. "Screening Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 65, pages 1219-1236, Springer.
- Shu Jiang & Graham A. Colditz, 2022. "Prevention Trials: Challenges in Design, Analysis, and Interpretation of Prevention Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 67, pages 1261-1277, Springer.
- Reza D. Mirza & Sunita Vohra & Richard Kravitz & Gordon H. Guyatt, 2022. "N-of-1 Randomized Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 68, pages 1279-1296, Springer.
- Patrick P. J. Phillips & David V. Glidden, 2022. "Noninferiority Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 69, pages 1297-1323, Springer.
- Steven Piantadosi & Susan Halabi, 2022. "Factorial Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 71, pages 1353-1376, Springer.
- Gui-Shuang Ying, 2022. "Within Person Randomized Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 72, pages 1377-1397, Springer.
- Heng Li & Pamela E. Scott & Lilly Q. Yue, 2022. "Device Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 73, pages 1399-1416, Springer.
- Valerii V. Fedorov, 2022. "Randomized Discontinuation Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 75, pages 1439-1453, Springer.
- Oleksandr Sverdlov & Ekkehard Glimm & Peter Mesenbrink, 2022. "Platform Trial Designs," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 76, pages 1455-1485, Springer.
- Lawrence H. Moulton & Richard J. Hayes, 2022. "Cluster Randomized Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 77, pages 1487-1505, Springer.
- Babak Choodari-Oskooei & Matthew R. Sydes & Patrick Royston & Mahesh K. B. Parmar, 2022. "Multi-arm Multi-stage (MAMS) Platform Randomized Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 78, pages 1507-1542, Springer.
- Nancy L. Geller, 2022. "Preview of Counting and Analysis Principles," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 81, pages 1589-1596, Springer.
- Judith D. Goldberg, 2022. "Intention to Treat and Alternative Approaches," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 82, pages 1597-1614, Springer.
- Pamela A. Shaw & Michael A. Proschan, 2022. "Estimation and Hypothesis Testing," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 83, pages 1615-1630, Springer.
- Estelle Russek-Cohen & David Petullo, 2022. "Estimands and Sensitivity Analyses," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 84, pages 1631-1657, Springer.
- Siyoen Kil & Eloise Kaizar & Szu-Yu Tang & Jason C. Hsu, 2022. "Confident Statistical Inference with Multiple Outcomes, Subgroups, and Other Issues of Multiplicity," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 85, pages 1659-1679, Springer.
- Guangyu Tong & Fan Li & Andrew S. Allen, 2022. "Missing Data," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 86, pages 1681-1701, Springer.
- Gregory R. Pond & Samantha-Jo Caetano, 2022. "Essential Statistical Tests," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 87, pages 1703-1716, Springer.
- Yuliya Lokhnygina, 2022. "Nonparametric Survival Analysis," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 88, pages 1717-1742, Springer.
- James J. Dignam, 2022. "Survival Analysis II," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 89, pages 1743-1770, Springer.
- Liang Li, 2022. "Prognostic Factor Analyses," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 90, pages 1771-1787, Springer.
- Márcio A. Diniz & Tiago M. Magalhães, 2022. "Logistic Regression and Related Methods," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 91, pages 1789-1811, Springer.
- Gina L. Mazza & Amylou C. Dueck, 2022. "Statistical Analysis of Patient-Reported Outcomes in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 92, pages 1813-1832, Springer.
- Sreelatha Meleth, 2022. "Adherence Adjusted Estimates in Randomized Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 93, pages 1833-1850, Springer.
- Vance W. Berger & Patrick Onghena & J. Rosser Matthews, 2022. "Randomization and Permutation Tests," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 94, pages 1851-1867, Springer.
- Willi Sauerbrei & Anne-Laure Boulesteix, 2022. "Use of Resampling Procedures to Investigate Issues of Model Building and Its Stability," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 96, pages 1895-1918, Springer.
- Zheng Lu & Emmanuel Chigutsa & Xiao Tong, 2022. "Joint Analysis of Longitudinal and Time-to-Event Data," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 97, pages 1919-1935, Springer.
- Jeff Jianfei Guo, 2022. "Safety and Risk Benefit Analyses," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 99, pages 1961-1980, Springer.
- Sabine Landau & Richard Emsley, 2022. "Causal Inference: Efficacy and Mechanism Evaluation," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 100, pages 1981-2002, Springer.
- Damien Drubay & Ben Van Calster & Stefan Michiels, 2022. "Development and Validation of Risk Prediction Models," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 101, pages 2003-2024, Springer.
- Stephen J. Greene & Marc D. Samsky & Adrian F. Hernandez, 2022. "Leveraging “Big Data” for the Design and Execution of Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 114, pages 2241-2262, Springer.
- Catherine M. Meyers & Qilu Yu, 2022. "Trials in Complementary and Integrative Health Interventions," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 115, pages 2263-2287, Springer.
- Stephen L. George & Marc Buyse & Steven Piantadosi, 2022. "Fraud in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 118, pages 2319-2337, Springer.
- John J. DeBoy & Annie X. Wang, 2022. "Clinical Trials on Trial: Lawsuits Stemming from Clinical Research," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 119, pages 2339-2366, Springer.
- L. C. Brown & A. L. Jorgensen & M. Antoniou & J. Wason, 2022. "Biomarker-Guided Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 62, pages 1145-1170, Springer.
- Otis W. Brawley, 2022. "Trials in Minority Populations," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 123, pages 2417-2429, Springer.
- Tracy Ziolek & Jessica L. Yoos & Inna Strakovsky & Praharsh Shah & Emily Robison, 2022. "Expanded Access to Drug and Device Products for Clinical Treatment," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 124, pages 2431-2451, Springer.
- Curtis L. Meinert & Steven Piantadosi, 2022. "A Perspective on the Process of Designing and Conducting Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 125, pages 2453-2473, Springer.
- Curtis L. Meinert, 2022. "Paper Writing," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 102, pages 2027-2043, Springer.
- S. Swaroop Vedula & Asbjørn Hróbjartsson & Matthew J. Page, 2022. "Reporting Biases," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 103, pages 2045-2071, Springer.
- Barbara S. Hawkins, 2022. "Publications from Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 105, pages 2089-2102, Springer.
- Curtis L. Meinert, 2022. "Study Name, Authorship, Titling, and Credits," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 106, pages 2103-2113, Springer.
- Sally Hopewell & Isabelle Boutron & David Moher, 2022. "CONSORT and Its Extensions for Reporting Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 104, pages 2073-2087, Springer.
- Ida Sim, 2022. "Data Sharing and Reuse," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 108, pages 2137-2158, Springer.
- Jimmy Le, 2022. "De-identifying Clinical Trial Data," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 107, pages 2115-2136, Springer.
- Tianjing Li & Ian J. Saldanha & Karen A. Robinson, 2022. "Introduction to Systematic Reviews," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 109, pages 2159-2177, Springer.
- Janet Wittes, 2022. "Reading and Interpreting the Literature on Randomized Controlled Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 111, pages 2197-2208, Springer.
- Laura E. Bothwell & Wen-Hua Kuo & David S. Jones & Scott H. Podolsky, 2022. "Social and Scientific History of Randomized Controlled Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 1, pages 3-19, Springer.
- Steven Piantadosi, 2022. "Evolution of Clinical Trials Science," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 2, pages 21-33, Springer.
- Curtis L. Meinert, 2022. "Terminology: Conventions and Recommendations," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 3, pages 35-54, Springer.
- O. Dale Williams & Barbara S. Hawkins, 2022. "History of the Society for Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 5, pages 73-81, Springer.
- Sheriza Baksh & Lijuan Zeng, 2022. "Data and Safety Monitoring and Reporting," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 37, pages 679-697, Springer.
- Amber Salter & J. Philip Miller, 2022. "Controlling for Multiplicity, Eligibility, and Exclusions," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 39, pages 729-737, Springer.
- Fan-fan Yu, 2022. "Principles of Clinical Trials: Bias and Precision Control," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 40, pages 739-765, Springer.
- Elizabeth Garrett-Mayer, 2022. "Power and Sample Size," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 41, pages 767-785, Springer.
- Bruce A. Barton, 2022. "Controlling Bias in Randomized Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 42, pages 787-803, Springer.
- George Howard & Jenifer H. Voeks, 2022. "Masking of Trial Investigators," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 43, pages 805-814, Springer.
- Lea Drye, 2022. "Masking Study Participants," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 44, pages 815-821, Springer.
- O. Dale Williams & Katrina Epnere, 2022. "Issues for Masked Data Monitoring," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 45, pages 823-832, Springer.
- Heidi L. Weiss & Jianrong Wu & Katrina Epnere & O. Dale Williams, 2022. "Variance Control Procedures," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 46, pages 833-841, Springer.
- Diane Uschner & William F. Rosenberger, 2022. "Bias Control in Randomized Controlled Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 48, pages 855-874, Springer.
- Wayne Rosamond & David Couper, 2022. "Ascertainment and Classification of Outcomes," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 47, pages 843-854, Springer.
- Steven Piantadosi, 2022. "Issues in Generalizing Results from Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 113, pages 2227-2240, Springer.
- Jonathan Kimmelman, 2022. "Clinical Trials, Ethics, and Human Protections Policies," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 4, pages 55-72, Springer.
- Claire Weber, 2022. "Training the Investigatorship," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 31, pages 583-591, Springer.
- Gillian Gresham & Patricia A. Ganz, 2022. "Patient-Reported Outcomes," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 51, pages 915-937, Springer.
- Byron Jones, 2022. "Cross-over Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 70, pages 1325-1351, Springer.
- Linda Sharples & Olympia Papachristofi, 2022. "Complex Intervention Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 74, pages 1417-1438, Springer.
- Suresh Ankolekar & Cyrus Mehta & Rajat Mukherjee & Sam Hsiao & Jennifer Smith & Tarek Haddad, 2022. "Monte Carlo Simulation for Trial Design Tool," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 80, pages 1563-1585, Springer.
- James E. Valentine & Frank J. Sasinowski, 2022. "Orphan Drugs and Rare Diseases," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 116, pages 2289-2306, Springer.
- Winifred Werther & Anita M. Loughlin, 2022. "Post-Approval Regulatory Requirements," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 38, pages 699-725, Springer.
- Gail D. Pearson & Kristin M. Burns & Victoria L. Pemberton, 2022. "Clinical Trials in Children," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 121, pages 2379-2395, Springer.
- Sergei Romashkan & Laurie Ryan, 2022. "Trials in Older Adults," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 122, pages 2397-2415, Springer.
- Gillian Gresham, 2022. "ClinicalTrials.gov," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 25, pages 479-495, Springer.
- Barbara K. Martin, 2022. "Financial Compliance in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 27, pages 521-539, Springer.
- Alfred Sommer, 2022. "Trials Can Inform or Misinform: “The Story of Vitamin A Deficiency and Childhood Mortality”," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 112, pages 2209-2224, Springer.
- Frank W. Rockhold & Benjamin A. Goldstein, 2022. "Pragmatic Randomized Trials Using Claims or Electronic Health Record Data," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 117, pages 2307-2317, Springer.
- James P. Long & J. Jack Lee, 2022. "Inferential Frameworks for Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 54, pages 973-1002, Springer.
- Johanna Mielke & Byron Jones, 2022. "Biosimilar Drug Development," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 66, pages 1237-1260, Springer.
- Trinidad Ajazi, 2022. "Responsibilities and Management of the Clinical Coordinating Center," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 32, pages 593-614, Springer.
- Julie D. Gottlieb, 2022. "Financial Conflicts of Interest in Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 28, pages 541-557, Springer.
- Boris Freidlin & Edward L. Korn, 2022. "Adaptive Phase II Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 61, pages 1133-1144, Springer.
- Marc Buyse & Julien Peron, 2022. "Generalized Pairwise Comparisons for Prioritized Outcomes," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 95, pages 1869-1893, Springer.
- Richard Simon, 2022. "Biomarker-Driven Adaptive Phase III Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 120, pages 2367-2378, Springer.
- Nicholas J. Seewald & Olivia Hackworth & Daniel Almirall, 2022. "Sequential, Multiple Assignment, Randomized Trials (SMART)," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 79, pages 1543-1561, Springer.
- Madhu Mazumdar & Xiaobo Zhong & Bart Ferket, 2022. "Diagnostic Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 63, pages 1171-1197, Springer.
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