Noninferiority Testing In Clinical Trials

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Noninferiority Testing in Clinical Trials

Author : Tie-Hua Ng
Publisher : CRC Press
ISBN 13 : 1466561491
Total Pages : 212 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Noninferiority Testing in Clinical Trials by : Tie-Hua Ng

Download or read book Noninferiority Testing in Clinical Trials written by Tie-Hua Ng and published by CRC Press. This book was released on 2014-12-01 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.

Clinical Trials in Neurology

Author : Bernard Ravina
Publisher : Cambridge University Press
ISBN 13 : 1107376572
Total Pages : 387 pages
Book Rating : 4.1/5 (73 download)

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Book Synopsis Clinical Trials in Neurology by : Bernard Ravina

Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.

Design and Analysis of Non-Inferiority Trials

Author : Mark D. Rothmann
Publisher : CRC Press
ISBN 13 : 1584888059
Total Pages : 451 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Design and Analysis of Non-Inferiority Trials by : Mark D. Rothmann

Download or read book Design and Analysis of Non-Inferiority Trials written by Mark D. Rothmann and published by CRC Press. This book was released on 2016-04-19 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Testing Statistical Hypotheses of Equivalence and Noninferiority

Author : Stefan Wellek
Publisher : CRC Press
ISBN 13 : 9781439808191
Total Pages : 431 pages
Book Rating : 4.8/5 (81 download)

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Book Synopsis Testing Statistical Hypotheses of Equivalence and Noninferiority by : Stefan Wellek

Download or read book Testing Statistical Hypotheses of Equivalence and Noninferiority written by Stefan Wellek and published by CRC Press. This book was released on 2010-06-24 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: While continuing to focus on methods of testing for two-sided equivalence, Testing Statistical Hypotheses of Equivalence and Noninferiority, Second Edition gives much more attention to noninferiority testing. It covers a spectrum of equivalence testing problems of both types, ranging from a one-sample problem with normally distributed observations

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309171148
Total Pages : 221 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727117
Total Pages : 954 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Testing Statistical Hypotheses of Equivalence

Author : Stefan Wellek
Publisher : CRC Press
ISBN 13 : 1420035967
Total Pages : 301 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Testing Statistical Hypotheses of Equivalence by : Stefan Wellek

Download or read book Testing Statistical Hypotheses of Equivalence written by Stefan Wellek and published by CRC Press. This book was released on 2002-11-12 with total page 301 pages. Available in PDF, EPUB and Kindle. Book excerpt: Equivalence testing has grown significantly in importance over the last two decades, especially as its relevance to a variety of applications has become understood. Yet published work on the general methodology remains scattered in specialists' journals, and for the most part, it focuses on the relatively narrow topic of bioequivalence assessment.

Strategy and Statistics in Clinical Trials

Author : Joseph Tal
Publisher : Academic Press
ISBN 13 : 0123869099
Total Pages : 279 pages
Book Rating : 4.1/5 (238 download)

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Book Synopsis Strategy and Statistics in Clinical Trials by : Joseph Tal

Download or read book Strategy and Statistics in Clinical Trials written by Joseph Tal and published by Academic Press. This book was released on 2011-07-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delineates the statistical building blocks and concepts of clinical trials.

Sample Sizes for Clinical Trials

Author : Steven A. Julious
Publisher : CRC Press
ISBN 13 : 1584887400
Total Pages : 330 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Sample Sizes for Clinical Trials by : Steven A. Julious

Download or read book Sample Sizes for Clinical Trials written by Steven A. Julious and published by CRC Press. This book was released on 2009-08-26 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including su

Statistics in Clinical and Observational Vaccine Studies

Author : Jozef Nauta
Publisher : Springer Nature
ISBN 13 : 3030376931
Total Pages : 234 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Statistics in Clinical and Observational Vaccine Studies by : Jozef Nauta

Download or read book Statistics in Clinical and Observational Vaccine Studies written by Jozef Nauta and published by Springer Nature. This book was released on 2020-03-14 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.

Multiple Testing Problems in Pharmaceutical Statistics

Author : Alex Dmitrienko
Publisher : CRC Press
ISBN 13 : 1584889853
Total Pages : 323 pages
Book Rating : 4.5/5 (848 download)

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Book Synopsis Multiple Testing Problems in Pharmaceutical Statistics by : Alex Dmitrienko

Download or read book Multiple Testing Problems in Pharmaceutical Statistics written by Alex Dmitrienko and published by CRC Press. This book was released on 2009-12-08 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c

Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials

Author : Meinhard Kieser
Publisher : Springer Nature
ISBN 13 : 3030495280
Total Pages : 391 pages
Book Rating : 4.0/5 (34 download)

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Book Synopsis Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials by : Meinhard Kieser

Download or read book Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials written by Meinhard Kieser and published by Springer Nature. This book was released on 2020-11-19 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an extensive overview of the principles and methods of sample size calculation and recalculation in clinical trials. Appropriate calculation of the required sample size is crucial for the success of clinical trials. At the same time, a sample size that is too small or too large is problematic due to ethical, scientific, and economic reasons. Therefore, state-of-the art methods are required when planning clinical trials. Part I describes a general framework for deriving sample size calculation procedures. This enables an understanding of the common principles underlying the numerous methods presented in the following chapters. Part II addresses the fixed sample size design, where the required sample size is determined in the planning stage and is not changed afterwards. It covers sample size calculation methods for superiority, non-inferiority, and equivalence trials, as well as comparisons between two and more than two groups. A wide range of further topics is discussed, including sample size calculation for multiple comparisons, safety assessment, and multi-regional trials. There is often some uncertainty about the assumptions to be made when calculating the sample size upfront. Part III presents methods that allow to modify the initially specified sample size based on new information that becomes available during the ongoing trial. Blinded sample size recalculation procedures for internal pilot study designs are considered, as well as methods for sample size reassessment in adaptive designs that use unblinded data from interim analyses. The application is illustrated using numerous clinical trial examples, and software code implementing the methods is provided. The book offers theoretical background and practical advice for biostatisticians and clinicians from the pharmaceutical industry and academia who are involved in clinical trials. Covering basic as well as more advanced and recently developed methods, it is suitable for beginners, experienced applied statisticians, and practitioners. To gain maximum benefit, readers should be familiar with introductory statistics. The content of this book has been successfully used for courses on the topic.

Statistical Thinking for Non-Statisticians in Drug Regulation

Author : Richard Kay
Publisher : John Wiley & Sons
ISBN 13 : 1119867401
Total Pages : 436 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis Statistical Thinking for Non-Statisticians in Drug Regulation by : Richard Kay

Download or read book Statistical Thinking for Non-Statisticians in Drug Regulation written by Richard Kay and published by John Wiley & Sons. This book was released on 2022-11-29 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Extending Medicare Reimbursement in Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309068886
Total Pages : 86 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Extending Medicare Reimbursement in Clinical Trials by : Institute of Medicine

Download or read book Extending Medicare Reimbursement in Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2000-03-17 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.

Clinical Trials Design in Operative and Non Operative Invasive Procedures

Author : Kamal M.F. Itani
Publisher : Springer
ISBN 13 : 3319538772
Total Pages : 495 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Clinical Trials Design in Operative and Non Operative Invasive Procedures by : Kamal M.F. Itani

Download or read book Clinical Trials Design in Operative and Non Operative Invasive Procedures written by Kamal M.F. Itani and published by Springer. This book was released on 2017-05-16 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Fundamentals of Clinical Trials

Author : Lawrence M. Friedman
Publisher : Springer Science & Business Media
ISBN 13 : 9780387985862
Total Pages : 384 pages
Book Rating : 4.9/5 (858 download)

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Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman

Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Critical Thinking in Clinical Research

Author : Felipe Fregni
Publisher : Oxford University Press
ISBN 13 : 0199324492
Total Pages : 537 pages
Book Rating : 4.1/5 (993 download)

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Book Synopsis Critical Thinking in Clinical Research by : Felipe Fregni

Download or read book Critical Thinking in Clinical Research written by Felipe Fregni and published by Oxford University Press. This book was released on 2018 with total page 537 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.