Principles and Practice of Clinical Trial Medicine Book

Principles and Practice of Clinical Trial Medicine


  • Author : Richard Yoonsik Chin
  • Publisher : Academic Press
  • Release Date : 2008
  • Genre: Medical
  • Pages : 547
  • ISBN 10 : 0123736951

DOWNLOAD BOOK
Principles and Practice of Clinical Trial Medicine Excerpt :

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 Research Book
Score: 4
From 3 Ratings

Principles and Practice of Clinical Research


  • Author : John I. Gallin
  • Publisher : Elsevier
  • Release Date : 2011-04-28
  • Genre: Medical
  • Pages : 448
  • ISBN 10 : 0080489567

DOWNLOAD BOOK
Principles and Practice of Clinical Research Excerpt :

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

Principles and Practice of Clinical Trials Book

Principles and Practice of Clinical Trials


  • Author : Steven Piantadosi
  • Publisher : Springer
  • Release Date : 2022-09-21
  • Genre: Medical
  • Pages : 0
  • ISBN 10 : 3319526359

DOWNLOAD BOOK
Principles and Practice of Clinical Trials Excerpt :

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 Clinical Trial Medicine Book
Score: 4.5
From 2 Ratings

Principles and Practice of Clinical Trial Medicine


  • Author : Richard Chin
  • Publisher : Elsevier
  • Release Date : 2008-07-25
  • Genre: Medical
  • Pages : 560
  • ISBN 10 : 0080557937

DOWNLOAD BOOK
Principles and Practice of Clinical Trial Medicine Excerpt :

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

Clinical Trials in Cancer Book

Clinical Trials in Cancer


  • Author : David J. Girling
  • Publisher : Oxford University Press, USA
  • Release Date : 2003
  • Genre: Medical
  • Pages : 367
  • ISBN 10 : 019262959X

DOWNLOAD BOOK
Clinical Trials in Cancer Excerpt :

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. DEGREESNL This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

Principles and Practice of Pharmaceutical Medicine Book
Score: 4.5
From 2 Ratings

Principles and Practice of Pharmaceutical Medicine


  • Author : Lionel D. Edwards
  • Publisher : John Wiley & Sons
  • Release Date : 2007-04-30
  • Genre: Medical
  • Pages : 780
  • ISBN 10 : 0470093145

DOWNLOAD BOOK
Principles and Practice of Pharmaceutical Medicine Excerpt :

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

Clinical Trials Book

Clinical Trials


  • Author : Stuart J. Pocock
  • Publisher : John Wiley & Sons
  • Release Date : 2013-07-17
  • Genre: Medical
  • Pages : 288
  • ISBN 10 : 9781118794104

DOWNLOAD BOOK
Clinical Trials Excerpt :

This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Principles of Good Clinical Practice Book

Principles of Good Clinical Practice


  • Author : Michael J. McGraw
  • Publisher : Pharmaceutical Press
  • Release Date : 2010
  • Genre: Medical
  • Pages : 256
  • ISBN 10 : 9780853697909

DOWNLOAD BOOK
Principles of Good Clinical Practice Excerpt :

This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and dependent ethics committees; clinical trial registration and reporting; quality assurance; and future implications for good clinical practices. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries

Sharing Clinical Trial Data Book

Sharing Clinical Trial Data


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2015-04-20
  • Genre: Medical
  • Pages : 304
  • ISBN 10 : 9780309316323

DOWNLOAD BOOK
Sharing Clinical Trial Data 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.

Principles and Practice of Clinical Research Book

Principles and Practice of Clinical Research


  • Author : John I. Gallin
  • Publisher : Academic Press
  • Release Date : 2017-11-17
  • Genre: Science
  • Pages : 824
  • ISBN 10 : 9780128499047

DOWNLOAD BOOK
Principles and Practice of Clinical Research Excerpt :

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Critical Thinking in Clinical Research Book
Score: 5
From 1 Ratings

Critical Thinking in Clinical Research


  • Author : Felipe Fregni
  • Publisher : Oxford University Press
  • Release Date : 2018
  • Genre: HEALTH & FITNESS
  • Pages : 518
  • ISBN 10 : 9780199324491

DOWNLOAD BOOK
Critical Thinking in Clinical Research Excerpt :

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Global Clinical Trials Book

Global Clinical Trials


  • Author : Richard Chin
  • Publisher : Academic Press
  • Release Date : 2011-05-06
  • Genre: Science
  • Pages : 522
  • ISBN 10 : 012381538X

DOWNLOAD BOOK
Global Clinical Trials Excerpt :

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

Principles and Practice of Phytotherapy   E Book Book
Score: 4
From 3 Ratings

Principles and Practice of Phytotherapy E Book


  • Author : Kerry Bone
  • Publisher : Elsevier Health Sciences
  • Release Date : 2013-01-08
  • Genre: Medical
  • Pages : 1056
  • ISBN 10 : 9780702052972

DOWNLOAD BOOK
Principles and Practice of Phytotherapy E Book Excerpt :

The authoritative and comprehensive modern textbook on western herbal medicine - now in its second edition This long-awaited second edition of Principles and Practice of Phytotherapy covers all major aspects of herbal medicine from fundamental concepts, traditional use and scientific research through to safety, effective dosage and clinical applications. Written by herbal practitioners with active experience in clinical practice, education, manufacturing and research, the textbook is both practical and evidence based. The focus, always, is on the importance of tailoring the treatment to the individual case. New insights are given into the herbal management of approxiately 100 modern ailments, including some of the most challenging medical conditions, such as asthma, inflammatory bowel disease and other complex autoimmune and inflammatory conditions, and there is vibrant discussion around the contribution of phytotherapy in general to modern health issues, including health ageing. Fully referenced throughout, with more than 10, 000 citations, the book is a core resource for students and practitioners of phytotherapy and naturopathy and will be of value to all healthcare professionals - pharmacists, doctors, nurses - with an interest in herbal therapeutics. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interaction chart. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interac

Quick Guide to Good Clinical Practice Book

Quick Guide to Good Clinical Practice


  • Author : Cemal Cingi
  • Publisher : Springer
  • Release Date : 2016-11-15
  • Genre: Medical
  • Pages : 237
  • ISBN 10 : 9783319443447

DOWNLOAD BOOK
Quick Guide to Good Clinical Practice Excerpt :

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Principles of Clinical Cancer Research Book

Principles of Clinical Cancer Research


  • Author : Loren K. Mell, MD
  • Publisher : Springer Publishing Company
  • Release Date : 2018-11-28
  • Genre: Medical
  • Pages : 576
  • ISBN 10 : 9781617052392

DOWNLOAD BOOK
Principles of Clinical Cancer Research Excerpt :

Principles of Clinical Cancer Research provides comprehensive coverage of the fundamentals of clinical cancer research, including the full spectrum of methodologies used in the field. For those involved in research or considering research careers, this book offers a mix of practical advice and analytical tools for effective training in theoretical principles as well as specific, usable teaching examples. The clinical oncologist or trainee will find a high-yield, practical guide to the interpretation of the oncology literature and the application of data to real-world settings. Valuable for both researchers and clinicians who wish to sharpen their skills, this book contains all of the cornerstones and explanations needed to produce and recognize quality clinical science in oncology. Written from the physician-scientist’s perspective, the book lays a strong foundation in preclinical sciences that is highly relevant to careers in translational oncology research along with coverage of population and outcomes research and clinical trials. It brings together fundamental principles in oncology with the statistical concepts one needs to know to design and interpret studies successfully. With each chapter including perspectives of both clinicians and scientists or biostatisticians, Principles of Clinical Cancer Research provides balanced, instructive, and high-quality topic overviews and applications that are accessible and thorough for anyone in the field. KEY FEATURES: Gives real-world examples and rationales behind which research methods to use when and why Includes numerous tables featuring key statistical methods and programming commands used in everyday clinical research Contains illustrative practical examples and figures in each chapter to help the reader master concepts Provides tips and pointers for structuring a career, avoiding pitfalls, and achieving success in the field of clinical cancer research Access to fully downloadable eBook