clinical trials and tribulations

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Clinical Drug Trials and Tribulations, Revised and Expanded, Second Edition
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release Date : 2002-03-26
ISBN 10 : 0824744802
Pages : 368 pages
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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.

Clinical Drug Trials and Tribulations
Author : Allen E. Cato
Publisher : Marcel Dekker Incorporated
Release Date : 1988
ISBN 10 :
Pages : 413 pages
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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

Clinical Studies in CRS and HIPEC: Trials, Tribulations, and Future Directions—A Systematic Review
Author : N.A
Publisher : N.A
Release Date : 2017
ISBN 10 :
Pages : 329 pages
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Abstract : Background: The field of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has suffered from a lack of clinical trials to validate its expanding use. Objective: To evaluate published and ongoing clinical trials seeking to better define role of CRS/HIPEC in the treatment of peritoneal surface malignancies. Methods: Systematic review by PubMed search was performed using terms "Clinical trial, " "intraperitoneal chemotherapy, " and "HIPEC."ClinicalTrials.gov and EudraCT registries were searched for active clinical trials. Eligibility included CRS/HIPEC trials investigating adult patient populations from published clinical reports and/or trials currently accruing or at completion. Results: Thirteen published trials and 57 active clinical trials were included for review. Conclusions: Published and ongoing U.S. and international clinical trials for CRS and HIPEC are defining important parameters that include improving patient selection, strategic sequences of treatment, cytoreductive strategies, chemotherapeutics, optimal hyperthermic temperature and timing, and toxicity profiles. Main barriers or limitations to trial development remain patient enrollment, trial design, and oncologic community collaboration. Overall progress is positive with increasing number of clinical trials throughout the world. Collaboration between surgeons and the wider oncologic community will be crucial to validate this important treatment strategy.

Oncology Clinical Trials
Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Release Date : 2009-12-22
ISBN 10 : 9781935281764
Pages : 168 pages
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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 genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

The Professional Guinea Pig
Author : Roberto Abadie
Publisher : Duke University Press
Release Date : 2010-07-09
ISBN 10 : 0822393247
Pages : 197 pages
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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.

Working In Clinical Research - A Personal Story
Author : Liam Mistry
Publisher : Independently Published
Release Date : 2021-04-03
ISBN 10 :
Pages : 102 pages
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The author describes his personal journey working in different clinical research environments and highlights his trials and tribulations so far within the industry. He also shares his views on working as a Clinical Research Associate and his experience of healthcare in the community. Furthermore he provides a spin on where he thinks the industry is heading in future and the importance of the patient in clinical trials.You could benefit from this book if: You want a unique insight into clinical research. You aspire to join the industry. You want top tips and useful information

Trials and Tribulations of Vascular Surgery
Author : Roger Malcolm Greenhalgh,F. G. R. Fowkes
Publisher : Bailliere Tindall Limited
Release Date : 1996
ISBN 10 :
Pages : 434 pages
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This volume examines the quality of research into a broad range vascular problems, and assesses the positive evidence for maintaining or changing investigative and treatment strategies. In addition, the authors identify research of dubious benefit and make recommendations for future research.

Wiley Encyclopedia of Clinical Trials
Author : Lisa Marie Sullivan,Joseph Massaro
Publisher : Wiley-Interscience
Release Date : 2008
ISBN 10 :
Pages : 1374 pages
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Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis

Her-2
Author : Robert Bazell
Publisher : Random House
Release Date : 2011-04-27
ISBN 10 : 0307764982
Pages : 240 pages
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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.

Psychiatry
Author : N.A
Publisher : N.A
Release Date : 1998
ISBN 10 :
Pages : 329 pages
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Drug Information
Author : Bonnie Snow
Publisher : Neal Schuman Pub
Release Date : 2008
ISBN 10 :
Pages : 546 pages
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This is the long-awaited third edition of the most comprehensive compilation of drug information resources available. A co-publication with the Medical Library Association, it draws on industry expert Bonnie Snow's 30+ years of experience with pharmaceutical information needs and applications. Snow reviews 400+ print and electronic resources.More than a bibliography, this readable guide brings together the best resources plus practical advice on everything from expert search techniques to core collections for libraries. Subject areas covered include: pharmaceutical technology; legal and regulatory issues world-wide; industrial pharmacy; market research; product guides and prescribing information in the global marketplace; drug interactions; drug effects on pregnancy, lactation, and reproduction; pharmacovigilance; and much, much more. Completely revised, reorganized, and updated, the third edition focuses on information sources not covered elsewhere. Absolutely unique in its value as both a desk reference and a text for classroom use or self-study, this edition manages to meet the needs of students, information professionals, health care providers, and pharmacy practitioners.

Clinical Evaluation of Psychotropic Drugs
Author : Robert F. Prien,Donald S. Robinson,National Institute of Mental Health (U.S.),American College of Neuropsychopharmacology
Publisher : Raven Press (ID)
Release Date : 1994
ISBN 10 :
Pages : 728 pages
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A source book in clinical methods for the understanding of psycho- pharmacologic agents and clinical evaluation of drugs in the treatment of mental disorder, produced in association with the National Institute of Mental health and the American College of Neuropsychopharmacology. The volume consists of three main sections. The first addresses the historical context of clinical psychopharmacologic research and guidelines and the decision process involved in drug development and evaluation. Section II addresses broad developments and issues for clinical methodology, providing guidance in research principles, study design and implementation, reporting of study findings, and ethical considerations involving drug evaluations. Section III provides methodologic developments and recommendations for research involving specific patient populations. Annotation copyright by Book News, Inc., Portland, OR