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Author: Curtis L. Meinert
Publisher: Curtis L. Meinert
Published: 1996
Total Pages: 490
ISBN-13:
DOWNLOAD EBOOK →Explanatory notes - Usage practice, cautions, and recommendations - Glossary of abbreviations and designations - Listing of entries References - Index
Author: Curtis L. Meinert
Publisher: John Wiley & Sons
Published: 2012-08-15
Total Pages: 449
ISBN-13: 1118315286
DOWNLOAD EBOOK →A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.
Author: Simon Day
Publisher: John Wiley & Sons
Published: 2007-04-30
Total Pages: 262
ISBN-13: 047031916X
DOWNLOAD EBOOK →As a result of the expansion in the area of pharmaceutical medicine there is an ever-increasing need for educational resources. The Dictionary of Clinical Trials, Second Edition comprehensively explains the 3000 words and short phrases commonly used when designing, running, analysing and reporting clinical trials. This book is a quick, pocket reference tool to understand the common and less well-used terms within the discipline of clinical trials, and provides an alternative to the textbooks available. Terms are heavily cross-referenced, which helps the reader to understand how terms fit into the broad picture of clinical trials. Wide ranging, brief, pragmatic explanations of clinical trial terminology Scope includes medical, statistical, epidemiological, ethical, regulatory and data management terminology Thoroughly revised and expanded - increase of 280 terms from First Edition, reference to Cochrane included From the reviews of the First Edition: "This invaluable text explains the majority of clinical trial terms, in alphabetical order, that are likely to be found in clinical trial protocols, reports, regulatory guidelines, and published manuscripts... Fully comprehensive - provides definitions of clinical trial terms in one complete volume... Includes extensive use of graphs throughout." LA DOC STI "...covers a range of subject matter, with emphasis on medical, statistical, epidemiological and ethical terms... a useful adjunct to standard clinical trial texts... a reference source to keep within easy reach." TALANTA The Dictionary of Clinical Trials, Second Edition is a ‘must-have’ for all pharmaceutical companies who conduct a lot of clinical trials, in all or one therapeutic area. The book is also of interest for public health and health science workers, and for contract research organisations and departments of medicine, where medics are involved with 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.
Author: Gerhard Nahler
Publisher: Springer Science & Business Media
Published: 2013-06-29
Total Pages: 186
ISBN-13: 3709140161
DOWNLOAD EBOOK →This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
Author: Curtis L. Meinert
Publisher: OUP USA
Published: 2012-03-27
Total Pages: 702
ISBN-13: 0195387880
DOWNLOAD EBOOK →The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2004-07-09
Total Pages: 445
ISBN-13: 0309133386
DOWNLOAD EBOOK →In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Author: Sanjay Gupta
Publisher: Dna Press
Published: 2010
Total Pages: 1
ISBN-13: 8190827715
DOWNLOAD EBOOK →This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1999-07-27
Total Pages: 88
ISBN-13: 0309172802
DOWNLOAD EBOOK →In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author: Lawrence M. Friedman
Publisher: Springer Science & Business Media
Published: 1998
Total Pages: 384
ISBN-13: 9780387985862
DOWNLOAD EBOOK →This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.
