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Clinical Trials And Death
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Book Synopsis Review of the Fialuridine (FIAU) Clinical Trials by : Institute of Medicine
Download or read book Review of the Fialuridine (FIAU) Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 1995-03-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: In June 1993 a clinical trial of fialuridine (FIAU), a promising new medication for hepatitis B, was abruptly terminated when one of the 15 out-patients participating in the National Institutes of Health (NIH) study was suddenly hospitalized with liver failure. Although all the remaining patients were contacted and told to stop taking their medication, six more subsequently developed severe toxicity. Five patients died, and two others were probably saved from death only by having liver transplants. In response to a request from the Secretary of the Department of Health and Human Services, the IOM committee has analyzed the FIAU clinical trials, making recommendations for additional safeguards for the conduct of future clinical trials. This evaluation included the review of documents pertaining to investigational new drug submissions, protocols and consent forms from other clinical trials, as well as information available from other clinical and preclinical experience with compounds related to FIAU and its parent drug, fiacitibine (FIAC), which is metabolized to FIAU. The committee does not seek to affix responsibility for the adverse outcome of this NIH trial, but instead focuses on whether any rules or procedures governing the clinical trials process itself need to be changed, and if so, what burdens or costs such changes might place on future clinical trials.
Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Clinical Trials and Death by : Patti Larsen
Download or read book Clinical Trials and Death written by Patti Larsen and published by Mayhem and Murder Ink. This book was released on 2022-04-19 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: Finding a cure for cancer can be murder... When Reading's ME, Dr. Lloyd Aberstock, asks Fiona Fleming to investigate a clinical trial, she's on the case immediately. With the life and death balance of his beloved Bernice in peril, Fee digs into Dr. Aberstock's concerns with help from her own husband, Crew. Fee uncovers deceit, sabotage and corporate espionage, all while trying to stay under the radar when one of the trial's doctors ends up dead. But is the drug a fraud, or will the death of its creator put Bernice's recovery at risk by ending the trial early? Available now from Fleming Investigations Cozy Mysteries: Patent Pending and Death Inquiring Minds and Death Finding Zen and Death All In and Death Out With the Old and Death Tropical Destinations and Death Family Enterprise and Death Clinical Trials and Death
Book Synopsis Global Clinical Trials for Alzheimer’s Disease by : H. Michael Arrighi
Download or read book Global Clinical Trials for Alzheimer’s Disease written by H. Michael Arrighi and published by Elsevier Inc. Chapters. This book was released on 2013-08-28 with total page 17 pages. Available in PDF, EPUB and Kindle. Book excerpt: Alzheimer’s disease (AD) confers an additional risk of death. The magnitude of this impact is related to the person’s underlying mortality and current AD stage. When planning clinical trials, estimating the number of deaths prior to study initiation, and periodically during the study as participants are enrolled, assists in providing an informative context, particularly if there are few life events. Additionally, deaths have the potential to introduce a bias, thus, equal follow-up needs to ensure for participants assigned to either active or placebo, particularly if the period of observation for safety events extends beyond the end of the study. During AD clinical trials, patients discontinue for reasons other than death and at substantially high rates, which has the potential to introduce significant bias. Planning and incorporating strategies to improve retention and identify successful techniques should be an integral part of the study process.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Book Synopsis Clinical Trials and Death by : Patti Larsen
Download or read book Clinical Trials and Death written by Patti Larsen and published by Patti Larsen Books. This book was released on with total page 109 pages. Available in PDF, EPUB and Kindle. Book excerpt: Finding a cure for cancer can be murder… When Reading’s ME, Dr. Lloyd Aberstock, asks Fiona Fleming to investigate a clinical trial, she’s on the case immediately. With the life and death balance of his beloved Bernice in peril, Fee digs into Dr. Aberstock’s concerns with help from her own husband, Crew. Fee uncovers deceit, sabotage and corporate espionage, all while trying to stay under the radar when one of the trial’s doctors ends up dead. But is the drug a fraud, or will the death of its creator put Bernice’s recovery at risk by ending the trial early? KEYWORDS: cozy murder mystery series, cozy murder mystery book, cozy mystery series, cozy mystery book, murder mystery series, murder mystery book, small town cozy mystery, dog mystery, dog cozy, animal cozy
Book Synopsis Medical Research and the Death Penalty by : Jack Kevorkian
Download or read book Medical Research and the Death Penalty written by Jack Kevorkian and published by . This book was released on 1960 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Handbook of Neuroemergency Clinical Trials by : Brett E. Skolnick
Download or read book Handbook of Neuroemergency Clinical Trials written by Brett E. Skolnick and published by Academic Press. This book was released on 2017-11-13 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development. Presents a comprehensive overview on clinical trials and drug development challenges in acute neuroscience populations Provides neurologists, neuroscientists and drug developers with a complete understanding of scientific and medical issues related to designing clinical trials Edited by leaders in the field who have designed and managed over 50 neuroemergency clinical trials
Book Synopsis Clinical Trials by : Lorna Speid, Ph.D
Download or read book Clinical Trials written by Lorna Speid, Ph.D and published by Oxford University Press. This book was released on 2010-07-30 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis A Concise Guide to Clinical Trials by : Allan Hackshaw
Download or read book A Concise Guide to Clinical Trials written by Allan Hackshaw and published by John Wiley & Sons. This book was released on 2011-09-07 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials have revolutionized the way disease is prevented, detected and treated, and early death avoided, and they continue to be an expanding area of research. They are central to the work of pharmaceutical companies, and there are many academic and public sector organizations that conduct trials on a wide variety of interventions, including drugs, devices, surgical techniques, and changes in behaviour and lifestyle. A Concise Guide to Clinical Trials provides a comprehensive yet easy-to-read overview of the design, conduct and analysis of trials. It requires no prior knowledge on the subject as the important concepts are introduced throughout. There are chapters that distinguish between the different types of trials, and an introduction to systematic reviews, health-related quality of life and health economic evaluation. The book also covers the ethical and legal requirements in setting up a clinical trial due to an increase in governance responsibilities and regulations. This practical guidebook is ideal for busy clinicians and other health professionals who do not have enough time to attend courses or search through extensive textbooks. It will help anyone involved in undertaking clinical research, or those reading about trials. The book is aimed at: Those wishing to learn about clinical trials for the first time, or as a quick reference guide, for example as part of a taught course on clinical trials Health professionals who wish to conduct their own trials, or participate in other people’s studies People who work in pharmaceutical companies, grant funding organisations, or regulatory agencies
Download or read book Dicing with Death written by Stephen Senn and published by Cambridge University Press. This book was released on 2003-11-20 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you think that statistics has nothing to say about what you do or how you could do it better, then you are either wrong or in need of a more interesting job. Stephen Senn explains here how statistics determines many decisions about medical care, from allocating resources for health, to determining which drugs to license, to cause-and-effect in relation to disease. He tackles big themes: clinical trials and the development of medicines, life tables, vaccines and their risks or lack of them, smoking and lung cancer and even the power of prayer. He entertains with puzzles and paradoxes and covers the lives of famous statistical pioneers. By the end of the book the reader will see how reasoning with probability is essential to making rational decisions in medicine, and how and when it can guide us when faced with choices that impact on our health and even life.
Book Synopsis DMT: The Spirit Molecule by : Rick Strassman
Download or read book DMT: The Spirit Molecule written by Rick Strassman and published by Simon and Schuster. This book was released on 2000-12-01 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clinical psychiatrist explores the effects of DMT, one of the most powerful psychedelics known. • A behind-the-scenes look at the cutting edge of psychedelic research. • Provides a unique scientific explanation for the phenomenon of alien abduction experiences. From 1990 to 1995 Dr. Rick Strassman conducted U.S. Government-approved and funded clinical research at the University of New Mexico in which he injected sixty volunteers with DMT, one of the most powerful psychedelics known. His detailed account of those sessions is an extraordinarily riveting inquiry into the nature of the human mind and the therapeutic potential of psychedelics. DMT, a plant-derived chemical found in the psychedelic Amazon brew, ayahuasca, is also manufactured by the human brain. In Strassman's volunteers, it consistently produced near-death and mystical experiences. Many reported convincing encounters with intelligent nonhuman presences, aliens, angels, and spirits. Nearly all felt that the sessions were among the most profound experiences of their lives. Strassman's research connects DMT with the pineal gland, considered by Hindus to be the site of the seventh chakra and by Rene Descartes to be the seat of the soul. DMT: The Spirit Molecule makes the bold case that DMT, naturally released by the pineal gland, facilitates the soul's movement in and out of the body and is an integral part of the birth and death experiences, as well as the highest states of meditation and even sexual transcendence. Strassman also believes that "alien abduction experiences" are brought on by accidental releases of DMT. If used wisely, DMT could trigger a period of remarkable progress in the scientific exploration of the most mystical regions of the human mind and soul.
Download or read book Postmortem written by Stefan Timmermans and published by University of Chicago Press. This book was released on 2008-11-15 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt: As elected coroners came to be replaced by medical examiners with scientific training, the American public became fascinated with their work. From the grisly investigations showcased on highly rated television shows like C.S.I. to the bestselling mysteries that revolve around forensic science, medical examiners have never been so visible—or compelling. They, and they alone, solve the riddle of suspicious death and the existential questions that come with it. Why did someone die? Could it have been prevented? Should someone be held accountable? What are the implications of ruling a death a suicide, a homicide, or an accident? Can medical examiners unmask the perfect crime? Postmortem goes deep inside the world of medical examiners to uncover the intricate web of pathological, social, legal, and moral issues in which they operate. Stefan Timmermans spent years in a medical examiner’s office, following cases, interviewing examiners, and watching autopsies. While he relates fascinating cases here, he is also more broadly interested in the cultural authority and responsibilities that come with being a medical examiner. Although these professionals attempt to remain objective, medical examiners are nonetheless responsible for evaluating subtle human intentions. Consequently, they may end—or start—criminal investigations, issue public health alerts, and even cause financial gain or harm to survivors. How medical examiners speak to the living on behalf of the dead, is Timmermans’s subject, revealed here in the day-to-day lives of the examiners themselves.
Book Synopsis Women and Health Research by : Institute of Medicine
Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.
Book Synopsis Cross-over Trials in Clinical Research by : Stephen S. Senn
Download or read book Cross-over Trials in Clinical Research written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2003-07-25 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Cross-over trials are an important class of design used in the pharmaceutical industry and medical research, and their use continues to grow. Cross-over Trials in Clinical Research, Second Edition has been fully updated to include the latest methodology used in the design and analysis of cross-over trials. It includes more background material, greater coverage of important statistical techniques, including Bayesian methods, and discussion of analysis using a number of statistical software packages. * Comprehensive coverage of the design and analysis of cross-over trials. * Each technique is carefully explained and the mathematics is kept to a minimum. * Features many real and original examples, taken from the author's vast experience. * Includes discussion of analysis using SAS, S-Plus and, GenStat, StatXact and Excel. * Written in a style suitable for statisticians and physicians alike. * Computer programs to accompany the examples in the book can be downloaded from the Web Primarily aimed at statisticians and researchers working in the pharmaceutical industry, the book will also appeal to physicians involved in clinical research and students of medical statistics.
