Phase Ii
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Phase Ii Clinical Development Of New Drugs
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Author : Naitee Ting
language : en
Publisher: Springer
Release Date : 2017-04-08
Phase Ii Clinical Development Of New Drugs written by Naitee Ting and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-04-08 with Medical categories.
This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.
A Practical Guide To Designing Phase Ii Trials In Oncology
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Author : Sarah R. Brown
language : en
Publisher: John Wiley & Sons
Release Date : 2014-05-12
A Practical Guide To Designing Phase Ii Trials In Oncology written by Sarah R. Brown 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 2014-05-12 with Medical categories.
How to identify optimal phase II trial designs Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, A Practical Guide to Designing Phase II Trials in Oncology sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization, and considering both academic and industry perspectives. A comprehensive and systematic library of available phase II trial designs is included, saving time otherwise spent considering multiple manuscripts, and real-life practical examples of using this approach to design phase II trials in cancer are given. A Practical Guide to Designing Phase II Trials in Oncology: Offers a structured and practical approach to phase II trial design Considers trial design from both an academic and industry perspective Includes a structured library of available phase II trial designs Is relevant to both clinical and statistical researchers at all levels Includes real life examples of applying this approach For those new to trial design, A Practical Guide to Designing Phase II Trials in Oncology will be a unique and practical learning tool, providing an introduction to the concepts behind informed decision making in phase II trials. For more experienced practitioners, the book will offer an overview of new, less familiar approaches to phase II trial design, providing alternative options to those which they may have previously used.
Evaluation Of Strategies For The Phase Ii To Phase Iii Progression In Treatment Discovery
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Author : Brittany J. Sanchez
language : en
Publisher:
Release Date : 2014
Evaluation Of Strategies For The Phase Ii To Phase Iii Progression In Treatment Discovery written by Brittany J. Sanchez and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with categories.
The goal of clinical research is to improve the health of the population through the prevention, diagnosis, and treatment of disease. Clinical trials are essential for reliably evaluating a proposed treatment to determine whether it should be adopted into clinical practice. Current standards involve the evaluation of a new treatment through several phases of investigation. After preliminary evaluations of the safety and ethics of further study, promising treatments are studied in preliminary screening trials and then ultimately large, confirmatory trials. Although well developed, the "treatment discovery process" is lengthy, expensive, and has low success rates for treatments even at confirmatory phases of the investigation. Improvements to trial design and implementation are necessary for better achieving the goals of clinical research. In this research, we consider the progression of studies for investigating a new treatment, and discuss strategies in a framework that encompasses the period from the start of preliminary Phase II studies to the completion of the confirmatory Phase III studies. Using a general notational framework for evaluating new treatments, we examine optimality criteria for a strategy that best addresses the often competing goals of science, ethics, and efficiency. These optimality criteria include not only the standard frequentest operating characteristics of type I error and power and the standard Bayesian criteria of positive and negative predictive values, but also the efficiency considerations of the number of new treatments identified in a setting with limited resources. We parameterize the Phase II and Phase III designs using frequentest type I error and power in such a way as to attain high Bayesian positive predictive value (PPV). We then explore the impact specific choices of those design parameters have on the number of effective and ineffective treatments identified with constrained resources. We illustrate how allowing for early trial termination for efficacy or futility with a group sequential design (GSD) within Phase II and/or Phase III improves efficiency in terms of the number of subjects used on average for identifying effective therapies. Other methods for improving efficiency by eliminating the time spent between Phase II and Phase III have been proposed. A "seamless" Phase II/III trial design is one that combines the Phase II screening stage with the Phase III confirmatory stage. We consider how a single sequential design differs from the optimal approach of independent stages. We then explore how the traditional approach of adapting hypotheses at the end of Phase II fits in with the newer adaptive methods. We discuss how powering of Phase III based on Phase II results mimics adaptive sample size re-estimation / re-powering of study and does not offer improvement beyond that of GSDs. Bias in the estimate of the treatment effect is a result of the lack of precision of small samples inherent in Phase II studies and at early interim analyses. We investigate how such bias can be addressed with adjustment methods. We then examine differences between conducting subgroup analyses when there exist homogeneous versus heterogeneous effects and how inflation of the type I error can be controlled in this setting and in the setting of considering multiple summary measures. In our research, we thus demonstrate that the optimal Phase II to Phase III progression defined by an acceptable PPV and a maximal number of effective treatments can be identified for an anticipated prevalence and hypothesized resources by a parameterization of type I error and power at Phase II. We recognize that several approaches lead to the same optimality criteria, and that the chosen strategy will depend on individual objectives of clinical researchers, trial sponsors, regulatory agencies, patients on study, and those who might benefit from new knowledge about treatments being studied.
Single Arm Phase Ii Survival Trial Design
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Author : Jianrong Wu
language : en
Publisher: CRC Press
Release Date : 2021-07-19
Single Arm Phase Ii Survival Trial Design written by Jianrong Wu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-07-19 with Mathematics categories.
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.
Handbook Of Phase Ii Clinical Trial Design
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Author : Yu Shyr
language : en
Publisher: CRC Press
Release Date : 2012
Handbook Of Phase Ii Clinical Trial Design written by Yu Shyr and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with Mathematics categories.
In the past, pharmaceutical companies have quickly jumped to Phase III without completion and full analysis of Phase II, which consequently led to failure. In the future, more emphasis needs to be placed on quality designed, conducted, and analyzed Phase II clinical trials. Focusing on Phase II clinical trials conducted in a sequential manner, this handbook presents modern techniques of clinical trial design, describes many Phase II designs, and discusses the software used for sample size and power analysis. It also provides sample size tables for those without the appropriate software to calculate sample size and power and includes numerous real-world examples of trial designs in use.
Research Safety Vehicle Program Phase Ii
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Author : Roy F. Macuga
language : en
Publisher:
Release Date : 1977
Research Safety Vehicle Program Phase Ii written by Roy F. Macuga and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with Automobile industry and trade categories.
Randomized Phase Ii Cancer Clinical Trials
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Author : Sin-Ho Jung
language : en
Publisher: CRC Press
Release Date : 2013-05-02
Randomized Phase Ii Cancer Clinical Trials written by Sin-Ho Jung and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-02 with Mathematics categories.
In cancer research, a traditional phase II trial is designed as a single-arm trial that compares the experimental therapy to a historical control. This simple trial design has led to several adverse issues, including increased false positivity of phase II trial results and negative phase III trials. To rectify these problems, oncologists and biosta
Phase Ii Final Report Nato Ccms Pilot Study
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Author :
language : en
Publisher: DIANE Publishing
Release Date : 1998
Phase Ii Final Report Nato Ccms Pilot Study written by and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Groundwater categories.
Bayesian Designs For Phase I Ii Clinical Trials
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Author : Ying Yuan
language : en
Publisher: CRC Press
Release Date : 2017-12-19
Bayesian Designs For Phase I Ii Clinical Trials written by Ying Yuan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-19 with Mathematics categories.
Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.
Single Arm Phase Ii Survival Trial Design
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Author : JIANRONG. WU
language : en
Publisher: CRC Press
Release Date : 2021-07-30
Single Arm Phase Ii Survival Trial Design written by JIANRONG. WU and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-07-30 with categories.
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software. Key Features: Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion. Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint. Illustrates trial designs by real clinical trial examples Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.
