Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition

Author: Allen Cato

Publisher: CRC Press

Published: 2002-03-26

Total Pages: 451

ISBN-13: 0824744802

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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.


Novel Therapies in Head and Neck Cancer: Beyond the Horizon

Novel Therapies in Head and Neck Cancer: Beyond the Horizon

Author: Maie A. St. John

Publisher: Academic Press

Published: 2020-06-29

Total Pages: 266

ISBN-13: 0128206799

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Novel Therapies in Head and Neck Cancer: Beyond the Horizon, Volume Twelve, provides a high-level synthesis of the latest treatments and outcomes relating to head and neck cancer. Chemotherapy and immunotherapy for those cancer types are rapidly evolving, and an updated source based on the expertise of internationally renowned researchers is necessary. This book discusses the outcome of recent trials using chemotherapy, novel approaches for HPV+ SCCA, cases in which immunotherapy is more likely to be successful, and precision medicine based on target therapies. Additionally, new approaches for rare diseases in head and neck and novel drug delivery platforms are presented. This book will be a very useful source so that students, scientists and clinicians who can be facile with the data, build on what is known, and continue to offer cutting-edge, validated therapies to all patients.


Clinical Drug Trials and Tribulations

Clinical Drug Trials and Tribulations

Author: Allen E. Cato

Publisher: Marcel Dekker

Published: 1988

Total Pages: 440

ISBN-13:

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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


Evidence-Based Orthopedics

Evidence-Based Orthopedics

Author: Mohit Bhandari

Publisher: John Wiley & Sons

Published: 2021-07-13

Total Pages: 1184

ISBN-13: 111941394X

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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.


ClinicalTrials

ClinicalTrials

Author: Curtis L. Meinert

Publisher: OUP USA

Published: 2012-03-27

Total Pages: 702

ISBN-13: 0195387880

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The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.


Her-2

Her-2

Author: Robert Bazell

Publisher: Random House

Published: 2011-04-27

Total Pages: 241

ISBN-13: 0307764982

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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.


The Professional Guinea Pig

The Professional Guinea Pig

Author: Roberto Abadie

Publisher: Duke University Press Books

Published: 2010-07-30

Total Pages: 0

ISBN-13: 9780822348146

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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.


Principles and Practice of Clinical Trials

Principles and Practice of Clinical Trials

Author: Steven Piantadosi

Publisher: Springer Nature

Published: 2022-07-19

Total Pages: 2573

ISBN-13: 3319526367

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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 in Neurology

Clinical Trials in Neurology

Author: Bernard Ravina

Publisher: Cambridge University Press

Published: 2012-04-12

Total Pages: 387

ISBN-13: 1107376572

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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.


Fundamentals of Clinical Trials

Fundamentals of Clinical Trials

Author: Lawrence M. Friedman

Publisher: Springer Science & Business Media

Published: 1998

Total Pages: 384

ISBN-13: 9780387985862

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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.