This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.
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
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.
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
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.
Now totally revised and rewritten for today’s female pelvic medicine and reconstructive surgery practice, Ostergard’s Textbook of Urogynecology: Female Pelvic Medicine & Reconstructive Surgery, 7th Edition, offers comprehensive guidance on all aspects of this complex field. Drs. Ali Azadi, Jeffrey L. Cornella, Peter L. Dwyer, and Felicia L. Lane bring you up to date with current diagnosis and treatment of all female pelvic floor dysfunctions, including urinary incontinence and other lower urinary tract conditions, disorders of the anus and rectum, and disorders of pelvic support. Thorough updates include revised and rewritten content throughout, new full-color illustrations, new surgical videos, new chapters on current clinical topics, and much more.
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.
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
With its expansion into the global marketplace, the pharmaceutical industry of today is uniquely positioned to improve the global health standards of society by saving lives and improving the quality of lives around the world. Modern Pharmaceutical Industry: A Primer comprehensively explains the broad range of divisions in this complex industry. Experts actively involved in each division discuss their own contribution to a pharmaceutical company's work and success. Divisions include regulatory affairs, research and development, intellectual property, pricing, marketing, generics, OTC, and more
Clinical Research in Oral Health surveys the essentials of clinical research in oral health, anchoring these principles within the specific context of the oral health arena. Addressing research questions exclusively applicable to dentistry and oral health, the book thoroughly illustrates the principles and practice of oral health clinical research. Clinical Research in Oral Health also clarifies the framework of regulatory issues and presents emerging concepts in clinical translation, relating the research principles to clinical improvement.
What is the best way to plan surgical research? What problems are most often encountered in clinical research? How should a research report be presented at a scientific meeting? These questions and more are all answered in Principles and Practice of Research.The second edition has added new sections on animal research models, the molecular and cellular dimension of surgical research, and practical guidelines for obtaining government and third-party funding. Other improvements include a friendlier discussion of statistics and updated material about on-line computer literature searches. This book provides every clinical researcher with a roadmap around the pitfalls of poorly designed studies, through the jungle of incomprehensible statistics, and over the hurdles of research reporting to a successful study from start to finish. From the reviews of the first edition: "For me, it is a bible and a must for every Ph.D. or M.D. involved in clinical research, especially in the field of surgery. It should be on the table - not on the book shelf - of both the young as well as the experienced investigator as a readily accessible source of information to avoid the trial-and-error approach to problems in surgical research." #World Journal of Surgery#1 "...a carefully conceived, concise blend of factual theory and principles, practical guidelines, and philosophical perspective... ...I have found it hard to identify any omission (even a selected bibliography on laboratory animals, their care, handling, and anatomy is included) and impossible to single out any individual contribution: each is a treasure - well written, concise, and complete." #The Lancet#2 "The feature of the book is that, despite attention to detail, it maintains a clear and practical approach to the whole field, beginning with the reasons for carrying out research, the types of research, and above all the reporting of research... ...Almost all aspects of research are covered, from small retrospective studies to departmental, institutional, national and international projects... ...The chapter on writing for publication should be compulsory reading for all budding authors." #Journal of Bone and Joint Surgery#3