Download or read book Platform Trial Designs in Drug Development written by Zoran Antonijevic and published by CRC Press. This book was released on 2018-12-07 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Development Economics on Trial written by Polly Hill and published by Cambridge University Press. This book was released on 1986-06-26 with total page 220 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the gulf that separates development economics from economic anthorpology.
Download or read book Randomized Control Trials in the Field of Development written by Florent Bédécarrats and published by Oxford University Press, USA. This book was released on 2020 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: In October 2019, Abhijit Banerjee, Esther Duflo, and Michael Kremer jointly won the 51st Sveriges Riksbank Prize in Economic Sciences in Memory of Alfred Nobel for their experimental approach to alleviating global poverty. But what is the exact scope of their experimental method, known as randomized control trials (RCTs)? Which sorts of questions are RCTs able to address and which do they fail to answer? The first of its kind, Randomized Control Trials in the Field of Development: A Critical Perspective provides answers to these questions, explaining how RCTs work, what they can achieve, why they sometimes fail, how they can be improved and why other methods are both useful and necessary. Bringing together leading specialists in the field from a range of backgrounds and disciplines (economics, econometrics, mathematics, statistics, political economy, socioeconomics, anthropology, philosophy, global health, epidemiology, and medicine), it presents a full and coherent picture of the main strengths and weaknesses of RCTs in the field of development. Looking beyond the epistemological, political, and ethical differences underlying many of the disagreements surrounding RCTs, it explores the implementation of RCTs on the ground, outside of their ideal theoretical conditions and reveals some unsuspected uses and effects, their disruptive potential, but also their political uses. The contributions uncover the implicit worldview that many RCTs draw on and disseminate, and probe the gap between the method's narrow scope and its success, while also proposing improvements and alternatives. Without disputing the contribution of RCTs to scientific knowledge, Randomized Control Trials in the Field of Development warns against the potential dangers of their excessive use, arguing that the best use for RCTs is not necessarily that which immediately springs to mind. Written in plain language, this book offers experts and laypeople alike a unique opportunity to come to an informed and reasoned judgement on RCTs and what they can bring to development.
Download or read book Football on Trial written by Eric Dunning and published by Routledge. This book was released on 2002-11-01 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the causes of football hooliganism as a world phenomenon, considering the links between player violence and crowd violence, and the role of the media. It looks ahead to the 1994 World Cup in Los Angeles and asks why soccer hooliganism has not been a problem in the USA.
Download or read book Youth on Trial written by Thomas Grisso and published by University of Chicago Press. This book was released on 2003 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt: Youths are on trial today in two ways. In the first sense, whereas youths once faced delinquency hearings in juvenile courts, now with increasing frequency they stand trial in criminal courts. In the second sense, recent reforms in juvenile justice have placed the notion of youth itself on trial. Society's trend toward responding to adolescent offenders as adults asks that we set aside traditional presumptions about adolescence as a condition of immaturity that warrants mitigation. The ensuing debate highlights the need for evidence to address whether youths' capacities are sufficiently different from adults to warrant different legal responses to their transgressions.
Download or read book Training on Trial written by James D. Kirkpatrick and published by HarperChristian + ORM. This book was released on 2022-03-29 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Using a courtroom trial as a metaphor, Training on Trial seeks to get to the truth about why training fails and puts the business partnership model to work for real. While upbeat lingo abounds about “complementing strategic objectives” and “driving productivity,” the fact is that most training does not make a significant enough impact on business results, and when it does, training professionals fail to make a convincing case about the value added to the bottom line. The vaunted “business partnership model” has yet to be realized?and in tough economic times, when the training budget is often the first to be cut, training is on trial for its very existence. Readers on both sides of the “courtroom” will learn how to: Build expertise and become genuinely involved in your company's or client's business Pledge to work together to positively impact a pressing business need or pivotal business opportunity Ask the jury their expectations and revise your own to be more realistic and mutually satisfying Develop a plan, targeting the key drivers of performance success after training has taken place Execute your initiative and deliver a stellar ROESM (Return on Expectations) A thought-provoking read for trainers and business unit leaders alike, Training on Trial provides a new application of the Kirkpatrick Four-Level Evaluation Model and a multitude of tips and techniques that allow lessons learned to be put into action now.
Download or read book Clinical Trials written by Steven Piantadosi and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. This book is accompanied by downloadable files available below under the DOWNLOADS tab. These files include: MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each. SAS PROGRAMS and DATA FILES used in the book. The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D: RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization. CRM – Implements the continual reassessment methods for dose finding clinical trials. OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method. POWER – This is a power and sample size program for clinical trials. Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.
Download or read book Construction Trial Deskbook written by Cathy Lilford Altman and published by American Bar Association. This book was released on 2022-05-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book serves as a resource for construction lawyers to prepare their cases for trial.
Download or read book Trial Justice written by Tim Allen and published by Zed Books Ltd.. This book was released on 2013-04-04 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Criminal Court (ICC) has run into serious problems with its first big case -- the situation in northern Uganda. There is no doubt that appalling crimes have occurred here. Over a million people have been forced to live in overcrowded displacement camps under the control of the Ugandan army. Joseph Kony's Lord's Resistance Army has abducted thousands, many of them children and has systematically tortured, raped, maimed and killed. Nevertheless, the ICC has confronted outright hostility from a wide range of groups, including traditional leaders, representatives of the Christian Churches and non-governmental organizations. Even the Ugandan government, which invited the court to become involved, has been expressing serious reservations. Tim Allen assesses the controversy. While recognizing the difficulties involved, he shows that much of the antipathy towards the ICC's intervention is misplaced. He also draws out important wider implications of what has happened. Criminal justice sets limits to compromise and undermines established procedures of negotiation with perpetrators of violence. Events in Uganda have far reaching implications for other war zones - and not only in Africa. Amnesties and peace talks may never be quite the same again.
Download or read book Learning Through Life s Trials written by Larry Richman and published by . This book was released on 2007-11-01 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: "You can choose to see a trial as a roadblock or an expressway. If you see it as a roadblock, it will obstruct your way. However, if you see it as an expressway, you can use it to learn and grow." "The gospel of Jesus Christ is the plan whereby we can become what God wants us to become. In fact, we become great people because of our trials, not in spite of them." This booklet reviews the nature, origins, and purposes of adversity and includes suggestions on how to patiently trust in the Lord and His eternal plan and how to use these trials to learn and grow stronger. You can benefit from your trials if you: Develop a relationship with God Let others help you Let God carry your burdens Trust that the Lord is in control and allow His will to be done Remember that everyone has challenges Let adversity make you a better person Live with integrity Be patient Make the best of your situation Serve others Keep a positive attitude Keep an eternal perspective
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.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book A Preliminary Treatise on Evidence at the Common Law written by James Bradley Thayer and published by . This book was released on 1898 with total page 682 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trial Simulations written by Holly H. C. Kimko and published by Springer Science & Business Media. This book was released on 2010-12-09 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.
Download or read book Clinical Trials written by Duolao Wang and published by Remedica. This book was released on 2006 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains statistics specifically for a medically literate audience. Readers gain not only an understanding of the basics of medical statistics, but also a critical insight into how to review and evaluate clinical trial evidence.
Download or read book Basic Trial Techniques written by Roberto A. Abad and published by . This book was released on 2018 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Practical Guide to Using Qualitative Research with Randomized Controlled Trials written by Alicia O'Cathain and published by Oxford University Press. This book was released on 2018-05-09 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers measure the effectiveness of new interventions using randomized controlled trials (RCTs). They are increasingly using qualitative research with these RCTs to explain the results of RCTs or facilitate the viability and efficiency of RCTs. A Practical Guide to Using Qualitative Research with Randomized Controlled Trials is a how-to book about the use of qualitative research with RCTs. Divided into three parts, this book covers the process of using qualitative research with RCTs from start to finish. Section one outlines overarching issues such as the many contributions qualitative research can make to generating evidence of effectiveness, section two provides practical guidance from writing a proposal through to publishing qualitative research undertaken with RCTs, and the final section guides the reader on how to engage with relevant stakeholders. Each chapter focuses on the key steps of undertaking qualitative research in RCTs, giving examples of how to write a proposal, select research questions, integrate qualitative and quantitative components, and much more. A Practical Guide to Using Qualitative Research with Randomized Controlled Trials is ideal for researchers who are leading, undertaking, or planning to use qualitative research with RCTs. With its detailed explanations and inspiring examples, this book is also useful for postgraduate students wishing to conduct qualitative research in the context of an RCT.
