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Design and Analysis of Non-Inferiority Trials

Design and Analysis of Non-Inferiority Trials PDF Author: Mark D. Rothmann
Publisher: CRC Press
ISBN: 1584888059
Category : Mathematics
Languages : en
Pages : 451

Book Description
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority tr

Design and Analysis of Non-Inferiority Trials

Design and Analysis of Non-Inferiority Trials PDF Author: Mark D. Rothmann
Publisher: CRC Press
ISBN: 1584888059
Category : Mathematics
Languages : en
Pages : 451

Book Description
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority tr

Inferiority by Design

Inferiority by Design PDF Author: Joseph R Gibson
Publisher:
ISBN:
Category :
Languages : en
Pages : 676

Book Description
Frances Cress Welsing defined inferiorization as "the conscious, deliberate and systematic process utilized specifically by a racist (white supremacist) social system, as conducted through all of its major and minor institutions...to mold specific peoples within that system (namely, all peoples classified by the racist system as non-white) into 'functional inferiors, ' in spite of their true genetic potential for functioning. Under the white supremacy system, the more melanin pigmentation present in the skin and thus the darker the individual, the greater the 'inferiorization' pressure imposed by the racist system. Thus, amongst all non-white peoples, Blacks are most victimized by this process." The brilliance of inferiorization is that it could make overt racism (White supremacy) obsolete, while simultaneously normalizing White supremacy in America. According to Bakari Kitwana, "Welsing argued that soon white supremacists wouldn't have to worry about making Blacks seem inferior they'd just need to keep providing them with inferior education, housing, health care, child care, and the like, and in a generation or two they would be." It is almost undeniable and most certainly observable that at this point in African-American history, institutionalized inferiorization, not simply racism (White supremacy), is by far our most dangerous enemy, yet it is the least constructively discussed or reacted to. In the 21st century, Black people's main problem is no longer some vaguely understood color line, but rather, according to Steve Biko, an "attitude of inferiority," which can also be defined as internalized racism (White supremacy). Internalized racism is characterized by the stigmatized race's acceptance of negative messages about their abilities and intrinsic worth. As a result, self-devaluation occurs. Suzanne Lipsky claimed that "internalized racism...has made us think of ourselves or each other as stupid, lazy, unimportant, or inferior." Na'im Akbar wrote that once you begin to believe "that you are not as good as other people, your actions follow your mind. The stage is now set for the cycle of a self-fulfilling prophecy: you believe they are superior and that you are inferior, and sure enough you will start acting inferior."

Sample Size Calculations in Clinical Research, Second Edition

Sample Size Calculations in Clinical Research, Second Edition PDF Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439870934
Category : Mathematics
Languages : en
Pages : 481

Book Description
Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Clinical Trials Design in Operative and Non Operative Invasive Procedures

Clinical Trials Design in Operative and Non Operative Invasive Procedures PDF Author: Kamal M.F. Itani
Publisher: Springer
ISBN: 3319538772
Category : Medical
Languages : en
Pages : 485

Book Description
The aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists

Elements of Clinical Study Design, Biostatistics & Research

Elements of Clinical Study Design, Biostatistics & Research PDF Author: S.S. Patel
Publisher: Bentham Science Publishers
ISBN: 9815123807
Category : Science
Languages : en
Pages : 152

Book Description
Frontiers in Clinical Drug Research – Diabetes and Obesity is a book series that brings updated reviews to readers interested in advances in the development of pharmaceutical agents for the treatment of two metabolic diseases – diabetes and obesity. The scope of the series covers a range of topics including the medicinal chemistry, pharmacology, molecular biology and biochemistry of natural and synthetic drugs affecting endocrine and metabolic processes linked with diabetes and obesity. Reviews in this series also include research on specific receptor targets and preclinical / clinical findings on novel pharmaceutical agents. Frontiers in Clinical Drug Research – Diabetes and Obesity is a valuable resource for pharmaceutical scientists and postgraduate students seeking updated and critically important information for developing clinical trials and devising research plans in the field of diabetes and obesity research. The sixth volume of this series features 6 reviews which are informative guides to therapy and drug administration in diabetes and metabolic syndrome, for both the medical specialist and the pharmacologist. The failing heart in diabetes with special emphasis on prevention Flavonoids as prominent antidiabetic agents Chemosensor in glucose monitoring, advances and challenges Synergistic drugs and polyherbal formulations for obesity: current status and future prospectives Urge for herbal antidiabetic medicines towards clinical and therapeutic implications Curcuma longa as a dietary supplement and medication for diabetes mellitus: evidence from experimental studies

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research PDF Author: Felipe Fregni
Publisher: Oxford University Press
ISBN: 0199324492
Category : Medical
Languages : en
Pages : 537

Book Description
Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Proceedings of the Section of Sciences

Proceedings of the Section of Sciences PDF Author: Koninklijke Nederlandse Akademie van Wetenschappen. Afdeling Natuurkunde
Publisher:
ISBN:
Category : Science
Languages : en
Pages : 786

Book Description


Teaching Evidence-Based Medicine

Teaching Evidence-Based Medicine PDF Author: Daniella A. Zipkin
Publisher: Springer Nature
ISBN: 3031111745
Category : Medical
Languages : en
Pages : 199

Book Description
Practicing evidence-based medicine is widely regarded both as best clinical practice, and as the cornerstone of meeting the ACGME competencies in Practice-Based Learning and Improvement. Training programs recognize the need to teach the skills of EBM and yet struggle with readily available content and guidance on putting together a curriculum. Time frames for delivering curricula in residency can be very tight, often restricted to scattered one hour conferences. This book provides a modular curriculum structure for instructors, with each topic area taking up one section, or one hour of instructional time. Developed over the past 14 years as an introductory course for interns in the internal medicine residency program at Duke, the curriculum will cover core content areas in evidence-based medicine and best teaching practices for them and skills such as literature searching and applying evidence to patients. Most importantly, it will center on actual patient questions and use current literature as examples that instructors can use as teaching exercises. There will also be ample diagrams that have been shown to be effective with learners and each module will include a video tutorial of a sample teaching session, including visual aids and small group teaching techniques. The curriculum can be implemented in any time frame necessary, compressed or longitudinal, to a variety of learners. This is an ideal guide for residency program directors and core faculty, either within internal medicine or more broadly in family medicine, pediatrics, surgery, OB-gyn, as well as medical school faculty for use with students.

Applied Statistics in Biomedicine and Clinical Trials Design

Applied Statistics in Biomedicine and Clinical Trials Design PDF Author: Zhen Chen
Publisher: Springer
ISBN: 3319126946
Category : Medical
Languages : en
Pages : 550

Book Description
This volume is a unique combination of papers that cover critical topics in biostatistics from academic, government, and industry perspectives. The 6 sections cover Bayesian methods in biomedical research; Diagnostic medicine and classification; Innovative Clinical Trials Design; Modelling and Data Analysis; Personalized Medicine; and Statistical Genomics. The real world applications are in clinical trials, diagnostic medicine and genetics. The peer-reviewed contributions were solicited and selected from some 400 presentations at the annual meeting of the International Chinese Statistical Association (ICSA), held with the International Society for Biopharmaceutical Statistics (ISBS). The conference was held in Bethesda in June 2013, and the material has been subsequently edited and expanded to cover the most recent developments.

Pragmatic Randomized Clinical Trials

Pragmatic Randomized Clinical Trials PDF Author: Cynthia J. Girman
Publisher: Academic Press
ISBN: 0128176644
Category : Science
Languages : en
Pages : 500

Book Description
Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed.This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. - Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) - Encompasses analytic aspects of such trials - Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records