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Clinical Trials And Tribulations
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Book Synopsis Clinical Trials and Tribulations by : Gayathri De Lanerolle
Download or read book Clinical Trials and Tribulations written by Gayathri De Lanerolle and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials. Covers key topics across pre-clinical, clinical research and clinical practice. Highlights areas such as the socioeconomics of conducting research, capacity and capability, research quality and performance (including performance indicators, adaptive design and practical solutions); Provides lessons learned from breach of protocols, ethical breaches, SAE/SUSARs, aseptic pharmacy preparation issues, and instability within research structures ; Includes a focus on the UK clinical research system, offering key insights into working within the UK and collaborating with UK partners.
Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato
Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato
Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Book Synopsis Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition by : Allen Cato
Download or read book Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition written by Allen Cato and published by CRC Press. This book was released on 2002-03-26 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.
Book Synopsis Clinical Drug Trials and Tribulations by : Allen E. Cato
Download or read book Clinical Drug Trials and Tribulations written by Allen E. Cato and published by Marcel Dekker. This book was released on 1988 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: A reference for pharmacologists, pharmacists, clinical chemists, drug regulators, and bioethicists, and a text for medical or pharmacy courses on drug development. The contributors address such topics as clinical drug development planning, causality in single-event drug reactions, pediatric drug tri
Book Synopsis The Professional Guinea Pig by : Roberto Abadie
Download or read book The Professional Guinea Pig written by Roberto Abadie and published by Duke University Press Books. This book was released on 2010-07-30 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Professional Guinea Pig documents the emergence of the professional research subject in Phase I clinical trials testing the safety of drugs in development. Until the mid-1970s Phase I trials were conducted on prisoners. After that practice was outlawed, the pharmaceutical industry needed a replacement population and began to aggressively recruit healthy, paid subjects, some of whom came to depend on the income, earning their living by continuously taking part in these trials. Drawing on ethnographic research among self-identified “professional guinea pigs” in Philadelphia, Roberto Abadie examines their experiences and views on the conduct of the trials and the risks they assume by participating. Some of the research subjects he met had taken part in more than eighty Phase I trials. While the professional guinea pigs tended to believe that most clinical trials pose only a moderate health risk, Abadie contends that the hazards presented by continuous participation, such as exposure to potentially dangerous drug interactions, are discounted or ignored by research subjects in need of money. The risks to professional guinea pigs are also disregarded by the pharmaceutical industry, which has become dependent on the routine participation of experienced research subjects. Arguing that financial incentives compromise the ethical imperative for informed consent to be freely given by clinical-trials subjects, Abadie confirms the need to reform policies regulating the participation of paid subjects in Phase I clinical trials.
Book Synopsis Trials and Tribulations by : Scott D. Halpern
Download or read book Trials and Tribulations written by Scott D. Halpern and published by . This book was released on 2002 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Her-2 written by Robert Bazell and published by Random House. This book was released on 2011-04-27 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: Two years after she underwent a mastectomy and chemotherapy, Barbara Bradfield's aggressive breast cancer had recurred and spread to her lungs. The outlook was grim. Then she took part in Genentech's clinical trials for a new drug. Five years later she remains cancer-free. Her-2 is the biography of Herceptin, the drug that provoked dramatic responses in Barbara Bradfield and other women in the trials and that offers promise for hundreds of thousands of breast cancer patients. Unlike chemotherapy or radiation, Herceptin has no disabling side effects. It works by inactivating Her-2/neu--a protein that makes cancer cells grow especially quickly-- produced by a gene found in 25 to 30 percent of all breast tumors. Herceptin caused some patients' cancers to disappear completely; in others, it slowed the progression of the disease and gave the women months or years they wouldn't otherwise have had. Herceptin is the first treatment targeted at a gene defect that gives rise to cancer. It marks the beginning of a new era of treatment for all kinds of cancers. Robert Bazell presents a riveting account of how Herceptin was born. Her-2 is a story of dramatic discoveries and strong personalities, showing the combination of scientific investigation, money, politics, ego, corporate decisions, patient activism, and luck involved in moving this groundbreaking drug from the lab to a patient's bedside. Bazell's deft portraits introduce us to the remarkable people instrumental in Herceptin's history, including Dr. Dennis Slamon, the driven UCLA oncologist who played the primary role in developing the treatment; Lily Tartikoff, wife of television executive Brandon Tartikoff, who tapped into Hollywood money and glamour to help fund Slamon's research; and Marti Nelson, who inspired the activists who lobbied for a "compassionate use" program that would allow women outside the clinical trials to have access to the limited supplies of Herceptin prior to FDA approval of the drug. And throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. Meticulously researched, written with clarity and compassion, Her-2 is masterly reporting on cutting-edge science.
Book Synopsis Clinical Trials by : Timothy M. Pawlik
Download or read book Clinical Trials written by Timothy M. Pawlik and published by Springer Nature. This book was released on 2020-03-10 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Evidence-Based Orthopedics by : Mohit Bhandari
Download or read book Evidence-Based Orthopedics written by Mohit Bhandari and published by John Wiley & Sons. This book was released on 2021-07-13 with total page 1184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evidence-Based Orthopedics is an up-to-date review of the best evidence for the diagnosis, management, and treatment of orthopedic conditions. Covering orthopedic surgery as well as pre- and post-operative complications, this comprehensive guide provides recommendations for implementing evidence-based practice in the clinical setting. Chapters written by leading clinicians and researchers in the field are supported by tables of evidence that summarize systematic reviews and randomized controlled trials. In areas where evidence is insufficient to recommend a practice, summaries of the available research are provided to assist in decision-making. This fully revised new edition reflects the most recent evidence using the approved evidence-based medicine (EBM) guidelines and methodology. The text now places greater emphasis on GRADE—a transparent framework for developing and presenting summaries of evidence—to allow readers to easily evaluate the quality of evidence and the strength of recommendations. The second edition offers a streamlined presentation and an improved standardized format emphasizing how evidence in each chapter directly affects clinical decisions. Incorporating a vast amount of new evidence, Evidence-Based Orthopedics: Features thoroughly revised and updated content, including a new chapter on pediatric orthopedics and new X-ray images Provides the evidence base for orthopedic surgery as well as pediatric orthopedics and orthopedic conditions requiring medical treatment Covers the different methods for most orthopedic surgical procedures, such as hip replacements, arthroscopy, and knee replacements Helps surgeons and orthopedic specialists achieve a uniform optimum standard through a condition-based approach Aligns with internationally accepted guidelines and best health economic principles Evidence-Based Orthopedics is an invaluable resource for orthopedic specialists, surgeons, trauma surgeons, trainees, and medical students.
Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book 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.
Book Synopsis ClinicalTrials by : Curtis L. Meinert
Download or read book ClinicalTrials written by Curtis L. Meinert and published by OUP USA. This book was released on 2012-03-27 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.
Book Synopsis Clinical Trials in Neurology by : Bernard Ravina
Download or read book Clinical Trials in Neurology written by Bernard Ravina and published by Cambridge University Press. This book was released on 2012-04-12 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Vitamin C and Cancer by : Evelleen Richards
Download or read book Vitamin C and Cancer written by Evelleen Richards and published by Springer. This book was released on 1991-06-18 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: A study of the development and rejection of vitamin C as a treatment for cancer, this text also explores the evaluation process of such a contentious treatment. Based on social, economic and financial considerations, it sees these decisions as political rather than objective assessments.
Author :Lawrence M. Friedman Publisher :Springer Science & Business Media ISBN 13 :9780387985862 Total Pages :384 pages Book Rating :4.9/5 (858 download)
Book Synopsis Fundamentals of Clinical Trials by : Lawrence M. Friedman
Download or read book Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media. This book was released on 1998 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Clinical Trial Design by : Sue Fitzpatrick
Download or read book Clinical Trial Design written by Sue Fitzpatrick and published by Inst of Clinical Research. This book was released on 2006 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gives advice on how to design a clinical trial and compares the different designs.
Book Synopsis Clinical Trials in Psychiatry by : Brian S. Everitt
Download or read book Clinical Trials in Psychiatry written by Brian S. Everitt and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First Edition: “Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read...it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY "The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications... an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE
