Sumario

Materias: Enlace del recurso

Materias:

“…Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. …”

Tabla de Contenidos: “…Intro -- FrontMatter -- Reviewers -- Acknowledgments -- Contents -- Boxes -- Abbreviations and Acronyms -- 1 Introduction -- 2 Effects of Evidence Gaps in Clinical Treatment for Pregnant and Lactating Persons -- 3 The Legal Landscape -- 4 Lessons Learned -- 5 Potential Practical Solutions for Including Pregnant and Lactating Persons in Clinical Trials -- 6 Promising Innovative Approaches to Evidence Generation -- 7 A Path Toward Inclusion -- Appendix A: References -- Appendix B: Workshop Agenda -- Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff…”

Tabla de Contenidos: “…Introduction to clinical trials / Brenda Wright -- Clinical trial phases / Brenda Wright -- Setting up of site, site assessment visits, and selection / Brenda Wright -- Regulatory requirements / Inge Vermeulen -- Contracts and agreements / Brenda Wright -- Protocol, informed consent documents, and investigator brochure / Brenda Wright -- Planning / Brenda Wright -- Recruitment and retention / Brenda Wright -- Training / Brenda Wright -- Data management / Annemie Stewart -- Investigational medicinal product (IMP) management / Wynand Smythe and Nicky Kramer -- Collecting, processing, and shipment of blood and urine samples / Brenda Wright -- Source document / Brenda Wright -- Screening, treatment, and safety follow-up visit / Brenda Wright -- Quality management / Brenda Wright -- Monitoring, close-out visits, and archiving / Brenda Wright -- Audits and inspections / Brenda Wright…”

Tabla de Contenidos: “…""Front Matter""; ""Acknowledgments""; ""Contents""; ""Glossary""; ""Summary""; ""1 Introduction and Background""; ""2 Trial Designs to Reduce the Frequency of Missing Data""; ""3 Trial Strategies to Reduce the Frequency of Missing Data""; ""4 Drawing Inferences from Incomplete Data""; ""5 Principles and Methods of Sensitivity Analyses""; ""6 Conclusions and Recommendations""; ""References""; ""Appendix A: Clinical Trials: Overview and Terminology""; ""Appendix B: Biographical Sketches of Panel Members and Staff""; ""Committee on National Statistics""…”

Tabla de Contenidos: “…""Front Matter""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes and Figure""; ""Discussion Framework for Clinical Trial Data Sharing""; ""References""; ""Appendix A: Statement of Task""; ""Appendix B: Committee Biographies""; ""Appendix C: Figure 1: Data Flow from Participant to Analyzed Data and Reporting""…”

Tabla de Contenidos: