Clinical Trials

Author: Lorna Speid, Ph.D
Publisher: Oxford University Press
ISBN: 9780199752805
Format: PDF, Mobi
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Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the trial. The patient who is terminally ill might participate in a clinical trial simply as a last hope for a cure. Whatever the goals, though, most participants will experience the same sense of bewilderment as they encounter the jargon and medical terminology that they will hear and have to read about and understand during the course of the clinical trial. Clinical Trials: What Patients and Volunteers Need to Know demystifies the entire process, focusing on the process of drug development, and the clinical trial itself. Writing from a lifetime of experience, the author provides important questions to ask those running a clinical trial, key definitions and terms for a participant to know and understand, as well as anecdotes illustrating the clinical trial process. The author also grapples with the idea of "informed consent," providing mechanisms for patients and volunteers to feel fully informed before signing up for the trial. A vital resource for those who are considering enrolling in a clinical trial, or for the parents, friends, or relatives of those involved in a clinical trial, this book takes away the mystery and allows the participant to enter a clinical trial feeling both informed and confident.

Healthy Volunteers in Commercial Clinical Drug Trials

Author: Shadreck Mwale
Publisher: Springer
ISBN: 3319592149
Format: PDF, ePub, Mobi
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This book provides a richly detailed contribution to the understanding of healthy volunteer experiences in clinical drug trials in the UK. Contemporary society, especially the West, has seen a significant increase in the production and use of pharmaceutical products, particularly for disease treatment. However, despite the large numbers of people involved, particularly in the UK, very little is known about their experiences in commercial phase I clinical drug trials. Shadreck Mwale critiques common conceptions of the terms ‘volunteer’ and ‘altruism’ as used in policy and practice of human involvement in clinical trials and calls for an awareness of the complexity of the terms and how the social contexts participants find themselves in shape acts of voluntarism. Based on extensive empirical evidence and conceptual analysis, the book presents new insights into the lives of healthy volunteers, challenges bioethical conceptions and generates new frameworks for policy and practice of FIHCTs. It will be of particular interest to scholars and practitioners in the wider social sciences, medical Sociology and medical anthropology, pharmacology and bioethics.

Understanding Clinical Trials

Author:
Publisher:
ISBN: 9781870403788
Format: PDF
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This publication aims to provide answers to some of the many questions which people affected by cancer may have about clinical trials. It should prove particularly useful for the patient who may be asked to enter a trial.

Informed Consent

Author: Kenneth Getz
Publisher: Centerwatch Incorporated
ISBN: 9781930624092
Format: PDF
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Informed consent (Medical law).

Ethical and Regulatory Aspects of Clinical Research

Author: Ezekiel J. Emanuel
Publisher:
ISBN:
Format: PDF, ePub, Docs
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"Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics." -- Bulletin of the World Health Organization "This book provides excellent matieral on a broad variety of ethical topics in clinical research." -- Quality Assurance Journal All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process.

Ethics Dumping

Author: Doris Schroeder
Publisher: Springer
ISBN: 3319647318
Format: PDF, Mobi
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This book is published under a CC BY 4.0 license. This book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.

The Professional Guinea Pig

Author: Roberto Abadie
Publisher: Duke University Press
ISBN: 0822393247
Format: PDF, Mobi
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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.

Transforming Clinical Research in the United States

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 9780309163354
Format: PDF, ePub, Docs
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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Patient Care and Professionalism

Author: Catherine DeAngelis
Publisher: Oxford University Press
ISBN: 0199926255
Format: PDF, Kindle
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The chapters in Patient Care and Professionalism are ordered so that the main character in this book, the patient, has the first voice, followed by the ancient history of professionalism, the recent resurrection of professionalism in the United Kingdom (UK), and finally professionalism in the United States (US). The eleven chapters cover the various health care professions: medicine, nursing, public health, law, leadership, religion, and finally a chapter on the science of professionalism. The chapters are all written by internationally known experts. The authors share their collective experience to shine light on professionalism from a new angle, revealing the way to a new kind of relationship for patients and physicians of the future-a rebirth of trust borne in real collaboration. The volume begins with a discussion of what is meant by the term 'advocacy' in the practice of medicine, and then offers perspectives on where opportunities for medical advocacy lie, the rich collaborations they engender, and ways to overcome systemic barriers to advocacy.

Oxford Textbook of Palliative Social Work

Author: Terry Altilio
Publisher: OUP USA
ISBN: 0199739110
Format: PDF, ePub, Docs
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The Oxford Textbook of Palliative Social Work is a comprehensive, evidence-informed text that addresses the needs of professionals who provide interdisciplinary, culturally sensitive, biopsychosocial-spiritual care for patients and families living with life-threatening illness. Social workers from diverse settings will benefit from its international scope and wealth of patient and family narratives. Unique to this scholarly text is its emphasis on the collaborative nature inherent in palliative care. This definitive resource is edited by two leading palliative social work pioneers who bring together an array of international authors who provide clinicians, researchers, policy-makers, and academics with a broad range of content to enrich the guidelines recommended by the National Consensus Project for Quality Palliative Care.