A Managers Guide To The Design And Conduct Of Clinical Trials
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| Author | : Phillip I. Good |
| Publisher | : John Wiley & Sons |
| Total Pages | : 244 |
| Release | : 2003-05-14 |
| Genre | : Mathematics |
| ISBN | : 0471461148 |
This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e-submissions and use of computers for direct data acquisition Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls
| Author | : JoAnn Pfeiffer |
| Publisher | : CRC Press |
| Total Pages | : 292 |
| Release | : 2017-05-18 |
| Genre | : Mathematics |
| ISBN | : 1315299771 |
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
| Author | : Duolao Wang |
| Publisher | : Remedica |
| Total Pages | : 497 |
| Release | : 2006 |
| Genre | : Medical |
| ISBN | : 1901346722 |
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.
| Author | : Stephen B. Hulley |
| Publisher | : Lippincott Williams & Wilkins |
| Total Pages | : 388 |
| Release | : 2011-11-30 |
| Genre | : Medical |
| ISBN | : 1451165854 |
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
| Author | : Bernard Ravina |
| Publisher | : Cambridge University Press |
| Total Pages | : 387 |
| Release | : 2012-04-12 |
| Genre | : Medical |
| ISBN | : 1107376572 |
Translating laboratory discoveries into successful therapeutics can be difficult. Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases. It introduces the reader to the key concepts underpinning trials in the neurosciences. This volume tackles the challenges of developing therapies for neurologic disorders from measurement of agents in the nervous system to the progression of clinical signs and symptoms through illustrating specific study designs and their applications to different therapeutic areas. Clinical Trials in Neurology covers key issues in Phase I, II and III clinical trials, as well as post-marketing safety surveillance. Topics addressed include regulatory and implementation issues, outcome measures and common problems in drug development. Written by a multidisciplinary team, this comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.
| Author | : Curtis L. Meinert |
| Publisher | : OUP USA |
| Total Pages | : 702 |
| Release | : 2012-03-27 |
| Genre | : Medical |
| ISBN | : 0195387880 |
The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.
| Author | : Phillip I. Good |
| Publisher | : John Wiley & Sons |
| Total Pages | : 272 |
| Release | : 2006-04-28 |
| Genre | : Mathematics |
| ISBN | : 0471930873 |
This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-"Plan,""Do," and "Check"-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: ". . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .." -Statistics in Medicine "The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies."-Technometrics "This book is must-have reading for anyone in the business . .." -Clinical Chemistry
| Author | : Tom Brody |
| Publisher | : Academic Press |
| Total Pages | : 897 |
| Release | : 2016-02-19 |
| Genre | : 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 | : Richard Chin |
| Publisher | : Academic Press |
| Total Pages | : 537 |
| Release | : 2011-05-06 |
| Genre | : Science |
| ISBN | : 012381538X |
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. - Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries - Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting - Case studies outline successes, failures, lessons learned and prospects for future collaboration - Includes country-specific guidelines for the most utilized countries - Foreword by David Feigel, former Head of CDRH at FDA
| Author | : David Machin |
| Publisher | : John Wiley & Sons |
| Total Pages | : 375 |
| Release | : 2010-05-20 |
| Genre | : Medical |
| ISBN | : 0470319224 |
Using examples and case studies from industry, academia and research literature, Randomized Clinical Trials provides a detailed overview of the key issues involved in designing, conducting, analysing and reporting randomized clinical trials. It examines the methodology for conducting Phase III clinical trials, developing the protocols, the practice for capturing, measuring, and analysing the resulting clinical data and their subsequent reporting. Randomized clinical trials are the principal method for determining the relative efficacy and safety of alternative treatments, interventions or medical devices. They are conducted by groups comprising one or more of pharmaceutical and allied health-care organisations, academic institutions, and charity supported research groups. In many cases such trials provide the key evidence necessary for the regulatory approval of a new product for future patient use. Randomized Clinical Trials provides comprehensive coverage of such trials, ranging from elementary to advanced level. Written by authors with considerable experience of clinical trials, Randomized Clinical Trials is an authoritative guide for clinicians, nurses, data managers and medical statisticians involved in clinical trials research and for health care professionals directly involved in patient care in a clinical trial context.
