Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine

Author: Richard Yoonsik Chin

Publisher: Academic Press

ISBN: 0123736951

Category: Medical

Page: 547

View: 590

A concise overview of the essential aspects of clinical research and trial design. Presents the principles and practical details needed to design, conduct, and interpret the results on clinical trials, as well as how to take a drug from initial development to approval stage.

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine

Author: Richard Chin

Publisher: Elsevier

ISBN: 0080557937

Category: Medical

Page: 560

View: 722

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials

Author: Steven Piantadosi

Publisher: Springer Nature

ISBN: 9783319526362

Category: Mathematics

Page: 2573

View: 724

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.

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine

Author: Lionel D. Edwards

Publisher: John Wiley & Sons

ISBN: 0470093145

Category: Medical

Page: 780

View: 691

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Global Clinical Trials Playbook

Global Clinical Trials Playbook

Author: Menghis Bairu

Publisher: Academic Press

ISBN: 9780124158603

Category: Medical

Page: 320

View: 410

Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research

Author: John I. Gallin

Publisher: Elsevier

ISBN: 0080489567

Category: Medical

Page: 448

View: 909

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government

Success in Academic Surgery: Clinical Trials

Success in Academic Surgery: Clinical Trials

Author: Timothy M. Pawlik

Publisher: Springer Science & Business Media

ISBN: 9781447146797

Category: Medical

Page: 183

View: 505

Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.

Principles and Practice of Multi-Agent Systems

Principles and Practice of Multi-Agent Systems

Author: Nirmit Desai

Publisher: Springer Science & Business Media

ISBN: 9783642259197

Category: Computers

Page: 665

View: 349

This book constitutes the thoroughly refereed post-conference proceedings of the 13th International Conference on Principles and Practice of Multi-Agent Systems, PRIMA 2010, held in Kolkata, India, in November 2010. The 18 full papers presented together with 15 early innovation papers were carefully reviewed and selected from over 63 submissions. They focus on practical aspects of multiagent systems and cover topics such as agent communication, agent cooperation and negotiation, agent reasoning, agent-based simulation, mobile and semantic agents, agent technologies for service computing, agent-based system development, ServAgents workshop, IAHC workshop, and PRACSYS workshop.

Clinical Trials

Clinical Trials

Author: Timothy M. Pawlik

Publisher: Springer Nature

ISBN: 9783030354886

Category: Medical

Page: 258

View: 149

This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.

Cancer Research and Clinical Trials in Developing Countries

Cancer Research and Clinical Trials in Developing Countries

Author: Daniela Cristina Stefan

Publisher: Springer

ISBN: 9783319184432

Category: Medical

Page: 218

View: 879

This book describes the principles around which cancer research and clinical trials can be developed. Additionally, by describing the particularities of planning and implementing cancer research in developing countries, this book provides valuable practical information for researchers in resource-rich countries who contemplate cooperating with scientists from limited-resource countries in performing research.Written and edited by leaders in the field who work in these developing countries, Cancer Research and Clinical Trials in Developing Countries: A Practical Guide will appeal to a wide range of researchers, students, and physicians who are engaging in cancer research and clinical trials. It focuses on methodology and statistics while structured around the needs of cancer research. It provides valuable information regarding international collaboration, funding mechanisms as well as publishing and dissemination of research findings.

Clinical Trials in Older Adults

Clinical Trials in Older Adults

Author: Antonio Cherubini

Publisher: John Wiley & Sons

ISBN: 9781118323472

Category: Medical

Page: 280

View: 643

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer’s dementia, depression, low muscle mass, cancer

Adaptive and Flexible Clinical Trials

Adaptive and Flexible Clinical Trials

Author: Richard Chin

Publisher: CRC Press

ISBN: 9781439838334

Category: Mathematics

Page: 198

View: 537

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.