Design Juries on Trial. 20th Anniversary Edition

Design Juries on Trial. 20th Anniversary Edition

Author: Kathryn H. Anthony

Publisher:

Published: 2012-04-01

Total Pages: 282

ISBN-13: 9780974845012

DOWNLOAD EBOOK

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...


Nature's Destiny

Nature's Destiny

Author: Michael Denton

Publisher: Simon and Schuster

Published: 2002-02

Total Pages: 482

ISBN-13: 0743237625

DOWNLOAD EBOOK

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.


Platform Trial Designs in Drug Development

Platform Trial Designs in Drug Development

Author: Zoran Antonijevic

Publisher: CRC Press

Published: 2018-12-07

Total Pages: 286

ISBN-13: 1351683926

DOWNLOAD EBOOK

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.


Clinical Trial Design

Clinical Trial Design

Author: Guosheng Yin

Publisher: John Wiley & Sons

Published: 2013-06-07

Total Pages: 368

ISBN-13: 1118183320

DOWNLOAD EBOOK

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.


Small Clinical Trials

Small Clinical Trials

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2001-01-01

Total Pages: 221

ISBN-13: 0309171148

DOWNLOAD EBOOK

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.


Recent Advances in Clinical Trial Design and Analysis

Recent Advances in Clinical Trial Design and Analysis

Author: Peter F. Thall

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 263

ISBN-13: 1461520096

DOWNLOAD EBOOK

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.


Designing Randomised Trials in Health, Education and the Social Sciences

Designing Randomised Trials in Health, Education and the Social Sciences

Author: D. Torgerson

Publisher: Springer

Published: 2008-03-13

Total Pages: 226

ISBN-13: 0230583997

DOWNLOAD EBOOK

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.


Practical Considerations for Adaptive Trial Design and Implementation

Practical Considerations for Adaptive Trial Design and Implementation

Author: Weili He

Publisher: Springer

Published: 2014-10-15

Total Pages: 420

ISBN-13: 1493911007

DOWNLOAD EBOOK

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.


Clinical Trials

Clinical Trials

Author: Tom Brody

Publisher: Academic Press

Published: 2016-02-19

Total Pages: 897

ISBN-13: 0128042583

DOWNLOAD EBOOK

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the "study schema" and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers


Art on Trial

Art on Trial

Author: David Gussak

Publisher: Columbia University Press

Published: 2013

Total Pages: 248

ISBN-13: 0231162502

DOWNLOAD EBOOK

Describing an outstanding example of the use of forensic art therapy in a criminal case, David Gussak, contracted by the defence to analyse the evidence in this instance, recounts his findings and presentation in court, as well as the future implications of his work for criminal proceedings.