Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition


  • Author : Allen Cato
  • Publisher : CRC Press
  • Release Date : 2002-03-26
  • Genre: Medical
  • Pages : 368
  • ISBN 10 : 0824703146

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Clinical Drug Trials and Tribulations Revised and Expanded Second Edition 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.

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition


  • Author : Allen Cato
  • Publisher : CRC Press
  • Release Date : 2002-03-26
  • Genre: Medical
  • Pages : 368
  • ISBN 10 : 9780824744809

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Clinical Drug Trials and Tribulations Revised and Expanded Second Edition 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.

The Professional Guinea Pig Book

The Professional Guinea Pig


  • Author : Roberto Abadie
  • Publisher : Duke University Press
  • Release Date : 2010-07-30
  • Genre: Social Science
  • Pages : 197
  • ISBN 10 : 9780822393245

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The Professional Guinea Pig 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.

Clinical Drug Trials and Tribulations Book

Clinical Drug Trials and Tribulations


  • Author : Allen E. Cato
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1988
  • Genre: Medical
  • Pages : 413
  • ISBN 10 : UOM:39015013228658

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Clinical Drug Trials and Tribulations 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

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition


  • Author : Allen Cato
  • Publisher : CRC Press
  • Release Date : 2002-03-26
  • Genre: Medical
  • Pages : 368
  • ISBN 10 : 1135556733

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Clinical Drug Trials and Tribulations Revised and Expanded Second Edition 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.

Trials and Tribulations Book

Trials and Tribulations


  • Author : Scott D. Halpern
  • Publisher : Unknown
  • Release Date : 2002
  • Genre: Uncategoriezed
  • Pages : 182
  • ISBN 10 : OCLC:244972852

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Trials and Tribulations Excerpt :

Her 2 Book

Her 2


  • Author : Robert Bazell
  • Publisher : Random House
  • Release Date : 2011-04-27
  • Genre: Health & Fitness
  • Pages : 240
  • ISBN 10 : 9780307764980

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Her 2 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 throughou

Novel Therapies in Head and Neck Cancer  Beyond the Horizon Book

Novel Therapies in Head and Neck Cancer Beyond the Horizon


  • Author : Maie A. St. John
  • Publisher : Academic Press
  • Release Date : 2020-06-29
  • Genre: Science
  • Pages : 266
  • ISBN 10 : 9780128209295

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Novel Therapies in Head and Neck Cancer Beyond the Horizon Excerpt :

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. Covers new chemotherapy trials, specifically on HPV and non-HPV related cancer types Discusses the application of immunotherapy to treat rare types of head and neck cancer Presents updated information on targeted therapies, specifically focusing on skin cancer in the region

Oncology Clinical Trials Book

Oncology Clinical Trials


  • Author : Susan Halabi, PhD
  • Publisher : Demos Medical Publishing
  • Release Date : 2009-12-22
  • Genre: Medical
  • Pages : 168
  • ISBN 10 : 1935281763

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Oncology Clinical Trials Excerpt :

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of ge

Clinical Trials in Psychiatry Book

Clinical Trials in Psychiatry


  • Author : Brian S. Everitt
  • Publisher : John Wiley & Sons
  • Release Date : 2008-04-15
  • Genre: Medical
  • Pages : 248
  • ISBN 10 : 047072384X

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Clinical Trials in Psychiatry 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

Palliative Care  Trials and COVID 19 Tribulations Book

Palliative Care Trials and COVID 19 Tribulations


  • Author : Cheng Hoon Chew
  • Publisher : Institute for Clinical Research, NIH, Malaysia
  • Release Date : 2021-09-09
  • Genre: Medical
  • Pages : 41
  • ISBN 10 : 978186723xxxx

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Palliative Care Trials and COVID 19 Tribulations Excerpt :

The COVID-19 pandemic started more than a year ago, but until today, we did not have a definitive cure for this disease. The SARS-CoV-2 virus constantly mutated over time, infecting more people and causing tremendous stress on the existing scarcity of healthcare resources all around the world. Here, the experts from ground zero will share their first-hand experience of clinical trials looking for a cure for COVID-19, like the WHO's Solidarity Trial and the role of palliative care in COVID-19 as part of humanitarian crisis management.

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

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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.

Oncology Clinical Trials Book

Oncology Clinical Trials


  • Author : William Kevin Kelly, DO
  • Publisher : Springer Publishing Company
  • Release Date : 2018-03-28
  • Genre: Medical
  • Pages : 600
  • ISBN 10 : 9780826168733

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Oncology Clinical Trials Excerpt :

The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all

Clinical Research Involving Pregnant Women Book

Clinical Research Involving Pregnant Women


  • Author : Françoise Baylis
  • Publisher : Springer
  • Release Date : 2017-01-02
  • Genre: Medical
  • Pages : 301
  • ISBN 10 : 9783319265124

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Clinical Research Involving Pregnant Women Excerpt :

This book discusses ‘how’ to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons ‘why’ the inclusion of pregnant women in clinical research is necessary – viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials.

Double Standards in Medical Research in Developing Countries Book

Double Standards in Medical Research in Developing Countries


  • Author : Ruth Macklin
  • Publisher : Cambridge University Press
  • Release Date : 2004-05-27
  • Genre: Law
  • Pages : 280
  • ISBN 10 : 0521541700

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Double Standards in Medical Research in Developing Countries Excerpt :

Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.