Clinical Trials What Patients And Volunteers Need To Know Speid Clinical Trials Book PDF, EPUB Download & Read Online Free

Clinical Trials
Author: Lorna Speid, Ph.D
Publisher: Oxford University Press
ISBN: 019975280X
Pages: 208
Year: 2010-07-30
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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.
The Medical Library Association Guide to Finding Out about Diabetes
Author: Dana L. Ladd, Alyssa Altshuler
Publisher: American Library Association
ISBN: 1555708900
Pages: 336
Year: 2013
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For the more than 26 million Americans diagnosed with or affected by diabetes, having accurate information on the disease is crucial. But the sheer volume of information available can be daunting for patients and caregivers alike. This comprehensive guide provides librarians and library users with background on key diabetes concepts, encompassing reliable print and electronic resources, including hard-to-find periodicals and audiovisual sources. Each chapter in this guide presents an overview and description as well as an annotated list of multi-format resources on topics including: Types 1 and 2 and gestational diabetes Diet, clinical trials, and support sources Legal and insurance issues With this guide, librarians can deepen their understanding and collections, and thus improve service to the growing number of patrons affected by, at-risk for, or curious about this pervasive disease.
Transforming Clinical Research in the United States
Author: Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation
Publisher: National Academies Press
ISBN: 0309163358
Pages: 150
Year: 2010-10-22
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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.
Designing Clinical Research
Author: Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman
Publisher: Lippincott Williams & Wilkins
ISBN: 1469840545
Pages: 378
Year: 2013-05-08
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Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This product incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing.
Public Engagement and Clinical Trials: New Models and Disruptive Technologies:
Author: Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine
Publisher: National Academies Press
ISBN: 0309219299
Pages: 140
Year: 2012-02-17
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Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
The CTSA Program at NIH:
Author: Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences, Board on Health Sciences Policy, Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284740
Pages: 178
Year: 2013-09-09
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In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.
FDA Regulatory Affairs
Author: Douglas J. Pisano, David S. Mantus
Publisher: Informa Health Care
ISBN: 1420073540
Pages: 464
Year: 2008-08-11
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Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track
Sharing Clinical Trial Data
Author: Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher: National Academies Press
ISBN: 0309316324
Pages: 304
Year: 2015-04-20
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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Principles and Practice of Pharmaceutical Medicine
Author: Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier
Publisher: John Wiley & Sons
ISBN: 1444348124
Pages: 800
Year: 2011-07-12
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The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, personalized medicine and growth in biotechnology as a source of new experimental drugs.
Integrating Clinical Research into Epidemic Response
Author: National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Global Health, Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
Publisher: National Academies Press
ISBN: 0309457769
Pages: 342
Year: 2017-07-26
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The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.
Basic Principles of Drug Discovery and Development
Author: Benjamin Blass
Publisher: Elsevier
ISBN: 012411525X
Pages: 580
Year: 2015-04-24
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Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, providing comprehensive explanations of enabling technologies such as high throughput screening, structure based drug design, molecular modeling, pharmaceutical profiling, and translational medicine, all areas that have become critical steps in the successful development of marketable therapeutics. The text introduces the fundamental principles of drug discovery and development, also discussing important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles in pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. It is designed to enable new scientists to rapidly understand the key fundamentals of drug discovery, including pharmacokinetics, toxicology, and intellectual property." Provides a clear explanation of how the pharmaceutical industry works Explains the complete drug discovery process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual propertyIdeal for anyone interested in learning about the drug discovery process and those contemplating careers in the industry Explains the transition process from academia or other industries
Addiction
Author: John Hoffman, Susan Froemke, Susan Cheever, Sheila Nevins
Publisher: Rodale Books
ISBN: 1609616979
Pages: 256
Year: 2007-03-20
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This companion book to the HBO documentary of the same name sheds light on the hidden American epidemic of addiction. Blending compelling personal narratives with statistics and expert opinion, all gleaned from over two years of research and reporting, ADDICTION offers a comprehensive and provocative look at the impact of chemical dependency on addicts, their loved ones, society, and the economy. Breaking the stigma that addicts are simply weak and immoral, it delves into new brain research proving that drugs and alcohol change the chemical composition of addicts' brains, making it veritably impossible for them to quit. The nation's top experts persuasively argue that the time has come for the blame to stop and the healing to begin. ADDICTION also features material not included in the documentary: testimonials, original graphics and images, additional elaboration on theories and treatments of addiction, and more. Featuring a foreword by Sheila Nevins, the president of Documentary and Family Programming at HBO, an afterward by the best-selling author Susan Cheever, and the writing of David Sheff, this book is essential reading for anyone who has been impacted by what is now realized to be a very real and widespread disease.
Bad Science
Author: Ben Goldacre
Publisher: McClelland & Stewart
ISBN: 0771035764
Pages: 304
Year: 2010-10-12
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The informative and witty expose of the "bad science" we are all subjected to, called "one of the essential reads of the year" by New Scientist. We are obsessed with our health. And yet — from the media's "world-expert microbiologist" with a mail-order Ph.D. in his garden shed laboratory, and via multiple health scares and miracle cures — we are constantly bombarded with inaccurate, contradictory, and sometimes even misleading information. Until now. Ben Goldacre masterfully dismantles the questionable science behind some of the great drug trials, court cases, and missed opportunities of our time, but he also goes further: out of the bullshit, he shows us the fascinating story of how we know what we know, and gives us the tools to uncover bad science for ourselves. From the Hardcover edition.
Understanding Clinical Research
Author: Renato D. Lopes, Robert A. Harrington
Publisher: McGraw Hill Professional
ISBN: 0071792651
Pages: 272
Year: 2013-05-22
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A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials
Conducting Clinical Trials
Author: Frank L. Iber, W. Anthony Riley, Patricia J. Murray
Publisher: Springer Science & Business Media
ISBN: 1461319196
Pages: 366
Year: 2012-12-06
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A few years ago, two of us joined our senior colleague at Pharma Kinetics Laboratories, a newly public contract research firm just under taking a major expansion into the clinical trials market. The company's unique concept of clinical research held great promise and had suc cessfully endured many of the fits and starts characteristic of entrepre neurial organizations. With a staff of highly enthusiastic, albeit inex perienced, field personnel located in 30-odd cities around the country, we found ourselves off and running with several critical research pro grams for major pharmaceutical manufacturers. Our excitement with the innovation was tempered with the reality of staffing and bearing responsibility for more than 30 field offices and 300 new staff persons, more than half of whom had no previous experience in the pharma ceutical industry. In the ensuing few years, we explored by trial and error many workable and unworkable patterns of training! delegation, data collec tion, and auditing. The ideas expressed in this book benefited greatly from that experience and from the willingness of our co-workers and clients to share insights and problems. During those years, we also sought guidance from the works available on the clinical trials field. Although we found numerous references on research ethics, little guid ance was available on the practical aspects of conducting a clinical trial.