Introduction To Adaptive Trial Designs And Master Protocols
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Introduction To Adaptive Trial Designs And Master Protocols
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Author : Jay J. H. Park
language : en
Publisher: Cambridge University Press
Release Date : 2023-04-06
Introduction To Adaptive Trial Designs And Master Protocols written by Jay J. H. Park and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-06 with Medical categories.
A unique and practical high-level introductory guide to the emerging field of adaptive trial designs, platform trials, and master protocols.
Innovative Methods For Rare Disease Drug Development
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Author : Shein-Chung Chow
language : en
Publisher: Chapman & Hall/CRC Biostatistics Series
Release Date : 2022-05
Innovative Methods For Rare Disease Drug Development written by Shein-Chung Chow and has been published by Chapman & Hall/CRC Biostatistics Series this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05 with Drug development categories.
Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives.
Precision Medicine In Neurodegenerative Disorders
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Author :
language : en
Publisher: Elsevier
Release Date : 2023-02-16
Precision Medicine In Neurodegenerative Disorders written by and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-02-16 with Medical categories.
Precision Medicine in Neurodegenerative Disorders, Part Two, Volume 193 in the Handbook of Clinical Neurology deals with the "How" in the reconfiguration of our approach to slow accelerated brain aging. The book rethinks animal models on which therapies are tested, outlines the progress and expected changes in biological subtyping efforts using lysosomal, endosomal, mitochondrial, immune dysregulation, and inflammatory mechanisms of disease pathophysiology, and the growing role of microbiome in shaping disease. The volume separates the potentially disease-modifying neurorescue and neurorestoration, (e.g., gene therapy and cell replacement therapy) from true precision "medicine"–matching biology with the mechanism of intervention of interest. Specific chapters are dedicated to the promise and challenges of extracellular vesicles for both diagnosis and treatment, the growing application of digital measures and other evaluations of clinical response, the nuts and bolts of novel adaptive clinical trial designs, and the regulatory changes needed to facilitate drug development for disease-modification purposes. - Summarizes theory and research on precision medicine in neurodegenerative disorders - Covers basic biology, clinical trials and therapeutics - Includes disease mechanisms, genetic subtypes, and more
Supply Chain Planning For Clinical Trials
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Author : Ryan Mills
language : en
Publisher: John Wiley & Sons
Release Date : 2024-08-13
Supply Chain Planning For Clinical Trials written by Ryan Mills and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-08-13 with Science categories.
Ensure your clinical trial supply chain is running smoothly with this practical guide Clinical trials are a critical part of the pharmaceutical development process. These trials cannot proceed without timely and regular receipt of the drugs being tested, which can prove a challenge for drug manufacturers who have not yet established the structures required to produce quality-controlled specimens of the drug at scale. Managing supply chains of pre-production drugs for clinical trials is therefore an essential component of drug development. Supply Chain Planning for Clinical Trials offers a practical introduction to this process for researchers and industry professionals. Beginning with the basics of clinical trial supply chain management, it proceeds step by step through all aspects of demand and supply planning for clinical trials. The result is a thorough overview that also offers practical examples of how to plan supply for clinical trials. Supply Chain Planning for Clinical Trials readers will also find: Tools for minimizing risk and expense by optimizing the relationship between supply and demand Detailed discussion of topics including quality and regulatory considerations and the business processes that support clinical trial supply chain management Spreadsheet-based models to illustrate key concepts, adaptable to the readers’ specific scenarios Supply Chain Planning for Clinical Trails is ideal for pharmaceutical industry professionals involved in clinical trial supply planning, as well as academics and researchers interested in the pharmaceutical industry and its logistics.
Cancer Clinical Trials
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Author : Stephen L. George
language : en
Publisher: CRC Press
Release Date : 2016-08-19
Cancer Clinical Trials written by Stephen L. George and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-19 with Mathematics categories.
Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.
Innovative Methods For Rare Disease Drug Development
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2020-11-11
Innovative Methods For Rare Disease Drug Development written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-11 with Mathematics categories.
In the United States, a rare disease is defined by the Orphan Drug Act as a disorder or condition that affects fewer than 200,000 persons. For the approval of "orphan" drug products for rare diseases, the traditional approach of power analysis for sample size calculation is not feasible because there are only limited number of subjects available for clinical trials. In this case, innovative approaches are needed for providing substantial evidence meeting the same standards for statistical assurance as drugs used to treat common conditions. Innovative Methods for Rare Disease Drug Development focuses on biostatistical applications in terms of design and analysis in pharmaceutical research and development from both regulatory and scientific (statistical) perspectives. Key Features: Reviews critical issues (e.g., endpoint/margin selection, sample size requirements, and complex innovative design). Provides better understanding of statistical concepts and methods which may be used in regulatory review and approval. Clarifies controversial statistical issues in regulatory review and approval accurately and reliably. Makes recommendations to evaluate rare diseases regulatory submissions. Proposes innovative study designs and statistical methods for rare diseases drug development, including n-of-1 trial design, adaptive trial design, and master protocols like platform trials. Provides insight regarding current regulatory guidance on rare diseases drug development like gene therapy.
Platform Trial Designs In Drug Development
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Author : Zoran Antonijevic
language : en
Publisher: CRC Press
Release Date : 2018-12-07
Platform Trial Designs In Drug Development written by Zoran Antonijevic and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-07 with Mathematics categories.
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
Designing Randomised Trials In Health Education And The Social Sciences
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Author : D. Torgerson
language : en
Publisher: Springer
Release Date : 2008-03-13
Designing Randomised Trials In Health Education And The Social Sciences written by D. Torgerson and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-13 with Social Science categories.
The book focuses on the design of rigorous trials rather than their statistical underpinnings, with chapters on: pragmatic designs; placebo designs; preference approaches; unequal allocation; economics; analytical approaches; randomization methods. It also includes a detailed description of randomization procedures and different trial designs.
Advanced Statistics In Regulatory Critical Clinical Initiatives
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Author : Wei Zhang
language : en
Publisher: CRC Press
Release Date : 2022-05-25
Advanced Statistics In Regulatory Critical Clinical Initiatives written by Wei Zhang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05-25 with Mathematics categories.
Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
Group Sequential Methods With Applications To Clinical Trials
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Author : Christopher Jennison
language : en
Publisher: CRC Press
Release Date : 1999-09-15
Group Sequential Methods With Applications To Clinical Trials written by Christopher Jennison and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1999-09-15 with Mathematics categories.
Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.