Author : Geert Molenberghs
Publisher : Springer Science & Business Media
Page : 440 pages
File Size : 45,20 MB
Release : 2005-02-28
Category : Mathematics
ISBN : 9780387202778
Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.
Author : Stephanie Green
Publisher : CRC Press
Page : 266 pages
File Size : 29,51 MB
Release : 2012-05-09
Category : Mathematics
ISBN : 1439814481
The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.
Author : Vinayak K. Prasad
Publisher : Johns Hopkins University Press
Page : 276 pages
File Size : 18,12 MB
Release : 2019-05-14
Category : Medical
ISBN : 1421429047
Why medicine adopts ineffective or harmful medical practices only to abandon them—sometimes too late. Medications such as Vioxx and procedures such as vertebroplasty for back pain are among the medical "advances" that turned out to be dangerous or useless. What Dr. Vinayak K. Prasad and Dr. Adam S. Cifu call medical reversal happens when doctors start using a medication, procedure, or diagnostic tool without a robust evidence base—and then stop using it when it is found not to help, or even to harm, patients. In Ending Medical Reversal, Drs. Prasad and Cifu narrate fascinating stories from every corner of medicine to explore why medical reversals occur, how they are harmful, and what can be done to avoid them. They explore the difference between medical innovations that improve care and those that only appear to be promising. They also outline a comprehensive plan to reform medical education, research funding and protocols, and the process for approving new drugs that will ensure that more of what gets done in doctors' offices and hospitals is truly effective.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 335 pages
File Size : 44,34 MB
Release : 2010-06-25
Category : Medical
ISBN : 0309157277
Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.
Author : Steven Piantadosi
Publisher : Springer Nature
Page : 2573 pages
File Size : 38,56 MB
Release : 2022-07-19
Category : Medical
ISBN : 3319526367
This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 236 pages
File Size : 28,5 MB
Release : 2015-04-20
Category : Medical
ISBN : 0309316324
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.
Author : Takeshi Emura
Publisher : Springer
Page : 94 pages
File Size : 50,33 MB
Release : 2018-04-05
Category : Medical
ISBN : 9811071640
This book introduces readers to copula-based statistical methods for analyzing survival data involving dependent censoring. Primarily focusing on likelihood-based methods performed under copula models, it is the first book solely devoted to the problem of dependent censoring. The book demonstrates the advantages of the copula-based methods in the context of medical research, especially with regard to cancer patients’ survival data. Needless to say, the statistical methods presented here can also be applied to many other branches of science, especially in reliability, where survival analysis plays an important role. The book can be used as a textbook for graduate coursework or a short course aimed at (bio-) statisticians. To deepen readers’ understanding of copula-based approaches, the book provides an accessible introduction to basic survival analysis and explains the mathematical foundations of copula-based survival models.
Author : National Research Council
Publisher : National Academies Press
Page : 163 pages
File Size : 27,66 MB
Release : 2010-12-21
Category : Medical
ISBN : 030918651X
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Author : Tom Brody
Publisher : Academic Press
Page : 897 pages
File Size : 35,55 MB
Release : 2016-02-19
Category : Medical
ISBN : 0128042583
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
Author : David Machin
Publisher : John Wiley & Sons
Page : 278 pages
File Size : 42,57 MB
Release : 2006-03-30
Category : Medical
ISBN : 0470870419
Well received in its first edition, Survival Analysis: A Practical Approach is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments. Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models. During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.
