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Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials—teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: Protocols for drug masking, controls, and treatment randomization Consent, enrollment, eligibility, and follow-up procedures Different types of sample size design and data collection and processing Working with study centers, research staff, and various committees Monitoring treatment effects and performance, and ensuring quality control Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.
"The book is a balanced and comprehensive treatment of an important social issue. It is accessible to the general reader and belongs in public as well as academic libraries." -- Religious Studies Review "Painstaking analysis of the knotty ethical problems involved in human-subjects research, and a well-thought-out proposal for a community approach to conducting field trials for an HIV vaccine.... Highly recommended for medical ethicists and anyone concerned about the AIDS epidemic and how HIV research is conducted."Â -- Kirkus Reviews "... a carefully reasoned account of how research for and trial of a preventive vaccine differ from the methods used to discover a therapy."Â -- Booklist "I highly recommend reading this book which I would attest to be a thrilling, ethically challenging, and informative descent into the allopathic solution." -- Ryan Hosken, Bastyr University Library Newsletter "As the scientific effort to produce an efficacious vaccine continues, [Grady's] work provides an ethical compass that will guide us well, regardless of where phase III HIV vaccine trials ultimately occur." -- Journal of the American Medical Association "Highly recommended... " -- AIDS Book Review Journal "A remarkable treatment of a most difficult and complex subject... Grady's book is of special merit because it is simple, readable, and understandable, while conveying in-depth perceptions that are critical to the reader. A useful and essential reference work for those who would engage in the initiative to bring about a resolution of a mighty human health problem." -- Maurice R. Hilleman, Ph.D., D.Sc., Director, Merck Institute for Therapeutic Research "Dr. Grady's important study captures the complexity of the search for an AIDS vaccine with startling clarity. Her insights into the full range of forces that shape our national response to AIDS vaccine development should read like signposts to vaccinologists, AIDS community activists, and most importantly, the Public Health Service. An impressive contribution." -- Derek Hodel, Gay Men's Health Crisis "This book is recommended to medical ethicists, those involved in non-HIV vaccine trials, and all persons involved in HIV vaccine trials, including investigators, sponsors, study subjects and communities at risk." -- Journal of Health Politics, Policy and Law The creation of a vaccine now seems the best hope for controlling AIDS. Yet developing and testing an HIV vaccine raises a host of difficult ethical issues. These concerns are the focus of this timely and important book. Essential reading for everyone interested in ethics and the conduct of HIV vaccine research.
The motivation and inspiration for this book come directly from expe- ences with clients during the years that I practiced HIV-related law at the Legal Aid Society of San Diego, Inc. The issues discussed in this work reflect issues that arose on a recurring basis with clients participating in HIV research studies, with investigators calling for guidance on the legal implications of particular aspects of their proposed studies, and with research institutions and health care facilities struggling to make sense of legal maneuvers aimed at obtaining the records of their HIV-infected patients. It is impossible to thank each of these persons individually for their provocative questions and their insights. The discussion of ethical and legal issues relating to the design of clinical trials reflects questions raised during discussions with Donald J. Slymen, Ph.D. Don was one of the first researchers, in my realm of experience, to pay close attention to ethical concerns, and I am greatly appreciative of his contribution to both my professional growth and the development of various scenarios discussed in this text. The portions of this text dealing with confidentiality are the result of many hours of thoughtful discussion and analysis with Penn Lerblance, J.D., now deceased and still missed. Penn and I often participated together as presenters of in-service training programs for health prof- sionals. Penn addressed discrimination, and I focused on confidentiality.
Covers the latest research on HIV and AIDS, including information on combined drug therapy, protease inhibitors, and other treatment options.
Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.