Design On Trial
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| Author | : Kathryn H. Anthony |
| Publisher | : |
| Total Pages | : 282 |
| Release | : 2012-04-01 |
| Genre | : |
| ISBN | : 9780974845012 |
20th anniversary of this award-winning classic. Design Juries on Trial goes hand in hand with 2 apps for iPhone iPodTouch and iPad: 1) Design Student Survival Guide and 2) Student Survival Guide. Both available from Apple iTunes store. Keep this guide at your side! Learn how to survive and thrive in design studios--and how to prepare, present and evaluate design projects in innovative, more effective ways. Empower yourself with this book to navigate your way through design school. Learn how to manage your time, research your project, communicate effectively, produce winning graphic presentations, master technology, handle design studio stress, work with teams...and much more. Schedule your project, achieve work/life balance, and avoid last-minute panic and disaster before design studio deadlines. Brings you unique insights into the jury process, with the most exhaustive analysis of the jury system undertaken to date. Reveals the hidden processes that jurors use to evaluate design work. Directs you to key research resources. Provides a historical and comparative overview of design juries. Advocates an array of refreshing reforms of the jury system to share with design instructors. Features interviews with luminaries in architecture, landscape architecture and interior design including Peter Eisenman, Michael Graves, Richard Meier, Cesar Pelli, Robert A. M. Stern, and others. Based on extensive research with over 900 individuals including systematic observations and videos of juries, diaries of design students, and interviews and surveys of students, faculty, and practitioners conducted over a seven-year period. More successful work habits more effective interactions with clients, healthier relationships with co-workers and a more favorable public image are the rewards of the approach presented in Design Juries on Trial. By applying these principles, students can more successfully make the leap from school into practice, and practitioners can develop more productive relations with all involved in the design and approval process. Shattering myths, challenging traditional assumptions, and calling for sweeping changes in design education and practice, Design Juries on Trial unlocks the door to the mysterious design jury system--exposing its hidden agendas and helping you overcome intimidation, confrontation, and frustration. It explains how to improve the success rate of submissions to juries--whether in the academic setting, for competitions and awards programs, or for professional accounts--and how to reconstruct the jury system in both design education and professional practice. Architects, landscape architects, planners, and interior, industrial, and graphic designers--as well as others who shape design decisions--are sure to benefit from this resource. Developed by award-winning faculty at the University of Illinois at Urbana-Champaign based on years of experience learning things the hard way...but you don't have to...
| Author | : Michael Denton |
| Publisher | : Simon and Schuster |
| Total Pages | : 482 |
| Release | : 2002-02 |
| Genre | : Science |
| ISBN | : 0743237625 |
A leading evolutionary thinker, biologist, and medical researcher asks the question: "Could life elsewhere be substantially different from life on Earth?"--and builds a step-by-step argument for human inevitability. 65 illustrations and photos.
| Author | : Guosheng Yin |
| Publisher | : John Wiley & Sons |
| Total Pages | : 368 |
| Release | : 2013-06-07 |
| Genre | : Medical |
| ISBN | : 1118183320 |
A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials. However, for phase III trials, frequentist methods still play a dominant role through controlling type I and type II errors in the hypothesis testing framework. From practical perspectives, Clinical Trial Design: Bayesian and Frequentist Adaptive Methods provides comprehensive coverage of both Bayesian and frequentist approaches to all phases of clinical trial design. Before underpinning various adaptive methods, the book establishes an overview of the fundamentals of clinical trials as well as a comparison of Bayesian and frequentist statistics. Recognizing that clinical trial design is one of the most important and useful skills in the pharmaceutical industry, this book provides detailed discussions on a variety of statistical designs, their properties, and operating characteristics for phase I, II, and III clinical trials as well as an introduction to phase IV trials. Many practical issues and challenges arising in clinical trials are addressed. Additional topics of coverage include: Risk and benefit analysis for toxicity and efficacy trade-offs Bayesian predictive probability trial monitoring Bayesian adaptive randomization Late onset toxicity and response Dose finding in drug combination trials Targeted therapy designs The author utilizes cutting-edge clinical trial designs and statistical methods that have been employed at the world's leading medical centers as well as in the pharmaceutical industry. The software used throughout the book is freely available on the book's related website, equipping readers with the necessary tools for designing clinical trials. Clinical Trial Design is an excellent book for courses on the topic at the graduate level. The book also serves as a valuable reference for statisticians and biostatisticians in the pharmaceutical industry as well as for researchers and practitioners who design, conduct, and monitor clinical trials in their everyday work.
| Author | : Mark Chang |
| Publisher | : John Wiley & Sons |
| Total Pages | : 284 |
| Release | : 2010-06-15 |
| Genre | : Medical |
| ISBN | : 0470438568 |
ExpDesign Studio facilitates more efficient clinical trial design This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: Covers both classical and adaptive clinical trial designs, monitoring, and analyses Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples Emphasizes applications, yet covers key mathematical formulations Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials. ERRATUM Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio By Mark Chang The license for the ExpDesign Studio software on the CD included with this book is good for one-year after installation of the software. Prior to the expiration of this period, the software will generate a reminder about renewal for the license. The user should contact CTriSoft International (the owners of ExpDesign Studio) at www.CTriSoft.net or by email at [email protected], about renewal for the license. This should have been made clear in the first printing of this book. We apologize for this error.
| Author | : David K. DeWolf |
| Publisher | : Discovery Institute |
| Total Pages | : 126 |
| Release | : 2006 |
| Genre | : Law |
| ISBN | : |
This book is is a legal critique of of the factual and legal flaws in Judge John E. Jones III's Kitzmiller et al. v. Dover Area School Board (2005), a controversial district court decision about the teaching of intelligent design in public schools. - Publisher.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 221 |
| Release | : 2001-01-01 |
| Genre | : Medical |
| ISBN | : 0309171148 |
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.
| Author | : D. Torgerson |
| Publisher | : Springer |
| Total Pages | : 226 |
| Release | : 2008-03-13 |
| Genre | : Social Science |
| ISBN | : 0230583997 |
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.
| Author | : Peter F. Thall |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 263 |
| Release | : 2012-12-06 |
| Genre | : Medical |
| ISBN | : 1461520096 |
Clinical trials have two purposes -- to treat the patients in the trial, and to obtain information which increases our understanding of the disease and especially how patients respond to treatment. Statistical design provides a means to achieve both these aims, while statistical data analysis provides methods for extracting useful information from the trial data. Recent advances in statistical computing have enabled statisticians to implement very rapidly a broad array of methods which previously were either impractical or impossible. Biostatisticians are now able to provide much greater support to medical researchers working in both clinical and laboratory settings. As our collective toolkit of techniques for analyzing data has grown, it has become increasingly difficult for biostatisticians to keep up with all the developments in our own field. Recent Advances in Clinical Trial Design and Analysis brings together biostatisticians doing cutting-edge research and explains some of the more recent developments in biostatistics to clinicians and scientists who work in clinical trials.
| Author | : Peter G. Smith |
| Publisher | : |
| Total Pages | : 479 |
| Release | : 2015 |
| Genre | : Health & Fitness |
| ISBN | : 0198732864 |
This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.
| Author | : Weili He |
| Publisher | : Springer |
| Total Pages | : 420 |
| Release | : 2014-10-15 |
| Genre | : Medical |
| ISBN | : 1493911007 |
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
