Healthy Volunteers in Commercial Clinical Drug Trials

Author: Shadreck Mwale
Publisher: Springer
ISBN: 3319592149
Format: PDF, ePub
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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.

The Ethics of Research with Human Subjects

Author: David B. Resnik
Publisher: Springer
ISBN: 3319687565
Format: PDF, Mobi
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This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.

Genetic Databases

Author: Oonagh Corrigan
Publisher: Routledge
ISBN: 113437335X
Format: PDF, Docs
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Genetic Databases offers a timely analysis of the underlying tensions, contradictions and limitations of the current regulatory frameworks for, and policy debates about, genetic databases. Drawing on original empirical research and theoretical debates in the fields of sociology, anthropology and legal studies, the contributors to this book challenge the prevailing orthodoxy of informed consent and explore the relationship between personal privacy and the public good. They also consider the multiple meanings attached to human tissue and the role of public consultations and commercial involvement in the creation and use of genetic databases. The authors argue that policy and regulatory frameworks produce a representation of participation that is often at odds with the experiences and understandings of those taking part. The findings present a serious challenge for public policy to provide mechanisms to safeguard the welfare of individuals participating in genetic databases.

Interferon

Author: Toine Pieters
Publisher: Routledge
ISBN: 1134293062
Format: PDF, ePub
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This innovative study charts the beginnings, history and fate of Interferon - one of modern medicine's most famous and infamous drugs. Interferon is part of the medical profession's armoury against viral infection, cancer and MS. The story of its development and use is one of survival in the face of remarkable cycles of promise and disappointment as a miracle drug. By telling this story, Toine Pieters' book provides insight into the research, manufacture, and marketing of new bio-molecules that mark modern medical science. Pieters' closely argued book adopts a multi-disciplinary approach in seeking to trace the extraordinary voyage of interferon. Through the lens of interferon's voyage, the book explores the interaction of the broad range of actors driving medical science: *biological and clinical researchers *the pharmaceutical industry *high-powered government agencies *doctors and patients *the media. The book demonstrates how research on interferon led to new clinical definitions of cancer and a new rationale for therapeutic use of the drug. Interferon provides a marvellous insight into the development of one of the most controversial drugs of our time. It enhances our understanding of how medicine manufacture and marketing all played a part in pushing back the boundaries of research, from the post-penicillin era to the genetics revolution in medicine. This study is of particular interest to undergraduates and postgraduates in the fields of History of Medicine, Pharmacology, Medical Genetics and History of Science.

Good Practice of Clinical Drug Trials

Author: Alain Spriet
Publisher: LIBRAIRIE LUGINBUHL
ISBN: 9783805577243
Format: PDF, ePub, Docs
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This new edition of Good Practice' is a totally revised and expanded version of this work. It takes into account the new quality guidelines, in particular those listed in the European Union Directive, the application texts and the recommendations of the International Conference on Harmonisation (ICH). It is a practical manual to help you conduct your clinical trials. Many new or revised concepts have been included, in particular: - Rationale for each rule presented - Safety of data in clinical trials - Protection of personal data - Conflicts of interest - Measures to be taken in case of suspected fraud

Clinical Pharmacology

Author: Morris J. Brown
Publisher: Elsevier Health Sciences
ISBN: 0702051136
Format: PDF, Docs
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A thorough knowledge of pharmacological and therapeutic principles is vital if drugs are to be used safely and effectively for increasingly informed patients. Those who clearly understand how drugs get into the body, how they produce their effects, what happens to them in the body, and how evidence of their therapeutic effect is assessed, will choose drugs more skilfully, and use them more safely and successfully than those who do not. Now in a fully revised 11th edition, Clinical Pharmacology is essential reading for undergraduate medical students, junior doctors and anyone concerned with evidence-based drug therapy. Introductory first three sections cover general principle of clinical pharmacology; five subsequent sections cover drug treatment of disease organised by body system. Retains approachable style set by the original author, Professor Laurence. Emphasis throughout is on evidence-based and safe drug prescribing. Indian Advisory Board will ensure content reflects the needs of the devloping world.

Clinical Pharmacology

Author: Peter N. Bennett
Publisher: Elsevier Health Sciences
ISBN: 0702039985
Format: PDF, ePub, Mobi
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This book is for students, doctors and indeed for all concerned with evidence-based drug therapy. A knowledge of pharmacological and therapeutic principles is essential if drugs/medicines are to be used safely and effectively for increasingly informed and critical patients. Doctors who understand how drugs get into the body, how they produce their effects, what happens to them in the body, and how evidence of their therapeutic effect is assessed, will choose drugs more skilfully, and use them more successfully than those who do not. The principles involved are neither so numerous nor so difficult to understand as to deter any prescriber, including those whose primary interests lie elsewhere than in pharmacology. All who use drugs cannot escape either the moral or the legal 'duty of care' to prescribe in an informed and responsible way. Introductory first three sections cover general principle of clinical pharmacology; five subsequent sections cover drug treatment of disease organised by body system. Retains approachable style set by the original author, Professor Laurence. Emphasis throughout is on evidence-based and safe drug prescribing. New colour design Increased use of graphics Slightly shorter by removal of out of date material