Clinical Trials on Trial: Lawsuits Stemming from Clinical Research (English)
- New search for: DeBoy, John J.
- New search for: Wang, Annie X.
- New search for: Piantadosi, Steven
- New search for: Meinert, Curtis L.
- New search for: DeBoy, John J.
- New search for: Wang, Annie X.
- New search for: Friedman, Lawrence
- New search for: Geller, Nancy L
In:
Principles and Practice of Clinical Trials
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Chapter: 164
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2339-2366
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2022
- Article/Chapter (Book) / Electronic Resource
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Title:Clinical Trials on Trial: Lawsuits Stemming from Clinical Research
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Contributors:Piantadosi, Steven ( editor ) / Meinert, Curtis L. ( editor ) / DeBoy, John J. ( author ) / Wang, Annie X. ( author ) / Friedman, Lawrence / Geller, Nancy L
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Published in:Principles and Practice of Clinical Trials ; Chapter: 164 ; 2339-2366
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Publisher:
- New search for: Springer International Publishing
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Place of publication:Cham
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Publication date:2022-07-20
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Size:28 pages
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ISBN:
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DOI:
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Type of media:Article/Chapter (Book)
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Type of material:Electronic Resource
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Language:English
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Keywords:
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Source:
Table of contents eBook
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 196
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Social and Scientific History of Randomized Controlled TrialsBothwell, Laura E. / Kuo, Wen-Hua / Jones, David S. / Podolsky, Scott H. et al. | 2022
- 198
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Evolution of Clinical Trials SciencePiantadosi, Steven et al. | 2022
- 200
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Terminology: Conventions and RecommendationsMeinert, Curtis L. et al. | 2022
- 238
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Clinical Trials, Ethics, and Human Protections PoliciesKimmelman, Jonathan et al. | 2022
- 208
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History of the Society for Clinical TrialsWilliams, O. Dale / Hawkins, Barbara S. et al. | 2022
- 29
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Investigator ResponsibilitiesGiantonio, Bruce J. et al. | 2022
- 30
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Centers Participating in Multicenter TrialsScherer, Roberta W. / Hawkins, Barbara S. et al. | 2022
- 283
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Qualifications of the Research StaffMeldrum, Catherine A. et al. | 2022
- 282
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Multicenter and Network TrialsBaksh, Sheriza et al. | 2022
- 32
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Principles of Protocol DevelopmentChen, Bingshu E. / Urton, Alison / Sadura, Anna / Parulekar, Wendy R. et al. | 2022
- 34
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Procurement and Distribution of Study MedicinesHardter, Eric / Collins, Julia / Shmueli-Blumberg, Dikla / Armstrong, Gillian et al. | 2022
- 35
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Selection of Study Centers and InvestigatorsShmueli-Blumberg, Dikla / Figueroa, Maria / Burke, Carolyn et al. | 2022
- 36
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Design and Development of the Study Data SystemCanham, Steve et al. | 2022
- 37
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Implementing the Trial ProtocolOughton, Jamie B. / Lilley-Kelly, Amanda et al. | 2022
- 38
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Participant Recruitment, Screening, and EnrollmentWermuth, Pascale et al. | 2022
- 39
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Administration of Study Treatments and Participant Follow-UpGassman, Jennifer J. et al. | 2022
- 40
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Data Capture, Data Management, and Quality Control; Single Versus Multicenter TrialsKnust, Kristin / Yesko, Lauren / Case, Ashley / Bickett, Kate et al. | 2022
- 41
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End of Trial and Close Out of Data CollectionBooth, Gillian et al. | 2022
- 44
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International TrialsBlacher, Lynette / Marillo, Linda et al. | 2022
- 45
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Documentation: Essential Documents and Standard Operating ProceduresMcFadden, Eleanor / Jackson, Julie / Forrest, Jane et al. | 2022
- 46
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Consent Forms and ProceduresErvin, Ann-Margret / Cobb Pettit, Joan B. et al. | 2022
- 47
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Contracts and BudgetsRiley, Eric / McFadden, Eleanor et al. | 2022
- 286
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Long-Term Management of Data and Secondary UseCanham, Steve et al. | 2022
- 51
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Regulatory Requirements in Clinical TrialsPernice, Michelle / Colley, Alan et al. | 2022
- 266
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ClinicalTrials.govGresham, Gillian et al. | 2022
- 55
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Funding Models and ProposalsWestmore, Matthew / Meadmore, Katie et al. | 2022
- 267
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Financial Compliance in Clinical TrialsMartin, Barbara K. et al. | 2022
- 275
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Financial Conflicts of Interest in Clinical TrialsGottlieb, Julie D. et al. | 2022
- 56
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Trial Organization and GovernanceWilliams, O. Dale / Epnere, Katrina et al. | 2022
- 57
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Advocacy and Patient Involvement in Clinical TrialsSigal, Ellen / Stewart, Mark / Merino, Diana et al. | 2022
- 240
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Training the InvestigatorshipWeber, Claire et al. | 2022
- 274
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Responsibilities and Management of the Clinical Coordinating CenterAjazi, Trinidad et al. | 2022
- 61
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Efficient Management of a Publicly Funded Cancer Clinical Trials PortfolioTangen, Catherine / LeBlanc, Michael et al. | 2022
- 62
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Archiving Records and MaterialsWerther, Winifred / Meinert, Curtis L. et al. | 2022
- 64
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Good Clinical PracticeWeber, Claire et al. | 2022
- 65
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Institutional Review Boards and Ethics CommitteesDunn, Keren R. et al. | 2022
- 209
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Data and Safety Monitoring and ReportingBaksh, Sheriza / Zeng, Lijuan et al. | 2022
- 256
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Post-Approval Regulatory RequirementsWerther, Winifred / Loughlin, Anita M. et al. | 2022
- 210
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Controlling for Multiplicity, Eligibility, and ExclusionsSalter, Amber / Miller, J. Philip et al. | 2022
- 211
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Principles of Clinical Trials: Bias and Precision ControlYu, Fan-fan et al. | 2022
- 213
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Power and Sample SizeGarrett-Mayer, Elizabeth et al. | 2022
- 214
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Controlling Bias in Randomized Clinical TrialsBarton, Bruce A. et al. | 2022
- 215
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Masking of Trial InvestigatorsHoward, George / Voeks, Jenifer H. et al. | 2022
- 216
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Masking Study ParticipantsDrye, Lea et al. | 2022
- 217
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Issues for Masked Data MonitoringWilliams, O. Dale / Epnere, Katrina et al. | 2022
- 218
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Variance Control ProceduresWeiss, Heidi L. / Wu, Jianrong / Epnere, Katrina / Williams, O. Dale et al. | 2022
- 233
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Ascertainment and Classification of OutcomesRosamond, Wayne / Couper, David et al. | 2022
- 219
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Bias Control in Randomized Controlled Clinical TrialsUschner, Diane / Rosenberger, William F. et al. | 2022
- 69
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Use of Historical Data in DesignKim, Christopher / Chia, Victoria / Kelsh, Michael et al. | 2022
- 70
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Outcomes in Clinical TrialsLeach, Justin M. / Aban, Inmaculada / Cutter, Gary R. et al. | 2022
- 241
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Patient-Reported OutcomesGresham, Gillian / Ganz, Patricia A. et al. | 2022
- 76
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Translational Clinical TrialsPiantadosi, Steven et al. | 2022
- 77
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Dose-Finding and Dose-Ranging StudiesConaway, Mark R. / Petroni, Gina R. et al. | 2022
- 271
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Inferential Frameworks for Clinical TrialsLong, James P. / Lee, J. Jack et al. | 2022
- 80
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Dose Finding for Drug CombinationsTighiouart, Mourad et al. | 2022
- 81
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Middle Development TrialsBayman, Emine O. et al. | 2022
- 82
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Randomized Selection DesignsLee, Shing M. / Levin, Bruce / Leu, Cheng-Shiun et al. | 2022
- 83
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Futility DesignsYeatts, Sharon D. / Palesch, Yuko Y. et al. | 2022
- 84
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Interim Analysis in Clinical TrialsKairalla, John A. / Zahigian, Rachel / Wu, Samuel S. et al. | 2022
- 92
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Bayesian Adaptive Designs for Phase I TrialsSweeting, Michael J. / Mander, Adrian P. / Wheeler, Graham M. et al. | 2022
- 276
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Adaptive Phase II TrialsFreidlin, Boris / Korn, Edward L. et al. | 2022
- 168
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Biomarker-Guided TrialsBrown, L. C. / Jorgensen, A. L. / Antoniou, M. / Wason, J. et al. | 2022
- 281
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Diagnostic TrialsMazumdar, Madhu / Zhong, Xiaobo / Ferket, Bart et al. | 2022
- 93
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Designs to Detect Disease ModificationMcDermott, Michael P. et al. | 2022
- 95
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Screening TrialsProrok, Philip C. et al. | 2022
- 272
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Biosimilar Drug DevelopmentMielke, Johanna / Jones, Byron et al. | 2022
- 96
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Prevention Trials: Challenges in Design, Analysis, and Interpretation of Prevention TrialsJiang, Shu / Colditz, Graham A. et al. | 2022
- 97
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N-of-1 Randomized TrialsMirza, Reza D. / Vohra, Sunita / Kravitz, Richard / Guyatt, Gordon H. et al. | 2022
- 98
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Noninferiority TrialsPhillips, Patrick P. J. / Glidden, David V. et al. | 2022
- 243
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Cross-over TrialsJones, Byron et al. | 2022
- 100
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Factorial TrialsPiantadosi, Steven / Halabi, Susan et al. | 2022
- 101
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Within Person Randomized TrialsYing, Gui-Shuang et al. | 2022
- 102
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Device TrialsLi, Heng / Scott, Pamela E. / Yue, Lilly Q. et al. | 2022
- 245
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Complex Intervention TrialsSharples, Linda / Papachristofi, Olympia et al. | 2022
- 104
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Randomized Discontinuation TrialsFedorov, Valerii V. et al. | 2022
- 107
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Platform Trial DesignsSverdlov, Oleksandr / Glimm, Ekkehard / Mesenbrink, Peter et al. | 2022
- 108
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Cluster Randomized TrialsMoulton, Lawrence H. / Hayes, Richard J. et al. | 2022
- 110
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Multi-arm Multi-stage (MAMS) Platform Randomized Clinical TrialsChoodari-Oskooei, Babak / Sydes, Matthew R. / Royston, Patrick / Parmar, Mahesh K. B. et al. | 2022
- 280
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Sequential, Multiple Assignment, Randomized Trials (SMART)Seewald, Nicholas J. / Hackworth, Olivia / Almirall, Daniel et al. | 2022
- 251
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Monte Carlo Simulation for Trial Design ToolAnkolekar, Suresh / Mehta, Cyrus / Mukherjee, Rajat / Hsiao, Sam / Smith, Jennifer / Haddad, Tarek et al. | 2022
- 112
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Preview of Counting and Analysis PrinciplesGeller, Nancy L. et al. | 2022
- 113
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Intention to Treat and Alternative ApproachesGoldberg, Judith D. et al. | 2022
- 114
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Estimation and Hypothesis TestingShaw, Pamela A. / Proschan, Michael A. et al. | 2022
- 115
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Estimands and Sensitivity AnalysesRussek-Cohen, Estelle / Petullo, David et al. | 2022
- 116
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Confident Statistical Inference with Multiple Outcomes, Subgroups, and Other Issues of MultiplicityKil, Siyoen / Kaizar, Eloise / Tang, Szu-Yu / Hsu, Jason C. et al. | 2022
- 117
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Missing DataTong, Guangyu / Li, Fan / Allen, Andrew S. et al. | 2022
- 118
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Essential Statistical TestsPond, Gregory R. / Caetano, Samantha-Jo et al. | 2022
- 119
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Nonparametric Survival AnalysisLokhnygina, Yuliya et al. | 2022
- 120
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Survival Analysis IIDignam, James J. et al. | 2022
- 121
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Prognostic Factor AnalysesLi, Liang et al. | 2022
- 122
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Logistic Regression and Related MethodsDiniz, Márcio A. / Magalhães, Tiago M. et al. | 2022
- 123
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Statistical Analysis of Patient-Reported Outcomes in Clinical TrialsMazza, Gina L. / Dueck, Amylou C. et al. | 2022
- 124
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Adherence Adjusted Estimates in Randomized Clinical TrialsMeleth, Sreelatha et al. | 2022
- 129
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Randomization and Permutation TestsBerger, Vance W. / Onghena, Patrick / Matthews, J. Rosser et al. | 2022
- 277
-
Generalized Pairwise Comparisons for Prioritized OutcomesBuyse, Marc / Peron, Julien et al. | 2022
- 130
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Use of Resampling Procedures to Investigate Issues of Model Building and Its StabilitySauerbrei, Willi / Boulesteix, Anne-Laure et al. | 2022
- 131
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Joint Analysis of Longitudinal and Time-to-Event DataLu, Zheng / Chigutsa, Emmanuel / Tong, Xiao et al. | 2022
- 284
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Pharmacokinetic and Pharmacodynamic ModelingKalaria, Shamir N. / Wang, Hechuan / Gobburu, Jogarao V. et al. | 2022
- 136
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Safety and Risk Benefit AnalysesGuo, Jeff Jianfei et al. | 2022
- 137
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Causal Inference: Efficacy and Mechanism EvaluationLandau, Sabine / Emsley, Richard et al. | 2022
- 138
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Development and Validation of Risk Prediction ModelsDrubay, Damien / Van Calster, Ben / Michiels, Stefan et al. | 2022
- 182
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Paper WritingMeinert, Curtis L. et al. | 2022
- 183
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Reporting BiasesVedula, S. Swaroop / Hróbjartsson, Asbjørn / Page, Matthew J. et al. | 2022
- 188
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CONSORT and Its Extensions for Reporting Clinical TrialsHopewell, Sally / Boutron, Isabelle / Moher, David et al. | 2022
- 184
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Publications from Clinical TrialsHawkins, Barbara S. et al. | 2022
- 187
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Study Name, Authorship, Titling, and CreditsMeinert, Curtis L. et al. | 2022
- 191
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De-identifying Clinical Trial DataLe, Jimmy et al. | 2022
- 190
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Data Sharing and ReuseSim, Ida et al. | 2022
- 194
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Introduction to Systematic ReviewsLi, Tianjing / Saldanha, Ian J. / Robinson, Karen A. et al. | 2022
- 287
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Introduction to Meta-AnalysisEvrenoglou, Theodoros / Metelli, Silvia / Chaimani, Anna et al. | 2022
- 195
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Reading and Interpreting the Literature on Randomized Controlled TrialsWittes, Janet et al. | 2022
- 268
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Trials Can Inform or Misinform: “The Story of Vitamin A Deficiency and Childhood Mortality”Sommer, Alfred et al. | 2022
- 236
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Issues in Generalizing Results from Clinical TrialsPiantadosi, Steven et al. | 2022
- 161
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Leveraging “Big Data” for the Design and Execution of Clinical TrialsGreene, Stephen J. / Samsky, Marc D. / Hernandez, Adrian F. et al. | 2022
- 162
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Trials in Complementary and Integrative Health InterventionsMeyers, Catherine M. / Yu, Qilu et al. | 2022
- 253
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Orphan Drugs and Rare DiseasesValentine, James E. / Sasinowski, Frank J. et al. | 2022
- 270
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Pragmatic Randomized Trials Using Claims or Electronic Health Record DataRockhold, Frank W. / Goldstein, Benjamin A. et al. | 2022
- 163
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Fraud in Clinical TrialsGeorge, Stephen L. / Buyse, Marc / Piantadosi, Steven et al. | 2022
- 164
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Clinical Trials on Trial: Lawsuits Stemming from Clinical ResearchDeBoy, John J. / Wang, Annie X. et al. | 2022
- 279
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Biomarker-Driven Adaptive Phase III Clinical TrialsSimon, Richard et al. | 2022
- 259
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Clinical Trials in ChildrenPearson, Gail D. / Burns, Kristin M. / Pemberton, Victoria L. et al. | 2022
- 260
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Trials in Older AdultsRomashkan, Sergei / Ryan, Laurie et al. | 2022
- 171
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Trials in Minority PopulationsBrawley, Otis W. et al. | 2022
- 172
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Expanded Access to Drug and Device Products for Clinical TreatmentZiolek, Tracy / Yoos, Jessica L. / Strakovsky, Inna / Shah, Praharsh / Robison, Emily et al. | 2022
- 175
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A Perspective on the Process of Designing and Conducting Clinical TrialsMeinert, Curtis L. / Piantadosi, Steven et al. | 2022