Author: Jack Myers
Publisher: Inkshares
ISBN: 1941758665
Category : Social Science
Languages : en
Pages : 342
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Book Description
“Once again, Jack Myers has his fingers on the pulse of the very latest. Myers has clearly done his homework, and the result is this superb book.” —Ken Burns, documentary filmmaker of The Roosevelts and The Civil War After being told all their lives to “be a man” and “man up,” men are now rejecting the macho stereotype and instead developing empathy, getting in touch with their emotions, and becoming more sensitive in their relationships. Women are gaining ground in business, culture, education, relationships, and politics as traditional male and female roles disappear. The Future of Men: Masculinity in the Twenty-First Century prepares men and women for this shift in gender norms. As the definition of a “real man” evolves, understanding the future of men in business, politics, sports, education, relationships, and parenting will be essential for men to maintain psychological well-being, strengthen their self-esteem and sexual self-confidence, and rewire their emotional lives. The Future of Men provides tools to help men, and especially younger men, recognize and embrace new behaviors that are required for health and happiness at work, at home, and in their relationships.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221
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Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309442583
Category : Medical
Languages : en
Pages : 111
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Book Description
On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.
Author: Jonathan Simon
Publisher: The New Press
ISBN: 1595587691
Category : Law
Languages : en
Pages : 226
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Book Description
Mass Incarceration on Trial examines a series of landmark decisions about prison conditions-culminating in Brown v. Plata, decided in May 2011 by the U.S. Supreme Court-that has opened an unexpected escape route from this trap of "tough on crime" politics. This set of rulings points toward values that could restore legitimate order to American prisons and, ultimately, lead to the demise of mass incarceration. This book offers a provocative and brilliant reading to the end of mass incarceration.
Author: Mollie Hemingway
Publisher: Simon and Schuster
ISBN: 1621579840
Category : Political Science
Languages : en
Pages : 256
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Book Description
#1 NATIONAL BESTSELLER! Justice Anthony Kennedy slipped out of the Supreme Court building on June 27, 2018, and traveled incognito to the White House to inform President Donald Trump that he was retiring, setting in motion a political process that his successor, Brett Kavanaugh, would denounce three months later as a “national disgrace” and a “circus.” Justice on Trial, the definitive insider’s account of Kavanaugh’s appointment to the Supreme Court, is based on extraordinary access to more than one hundred key figures—including the president, justices, and senators—in that ferocious political drama. The Trump presidency opened with the appointment of Neil Gorsuch to succeed the late Antonin Scalia on the Supreme Court. But the following year, when Trump drew from the same list of candidates for his nomination of Brett Kavanaugh, the justice being replaced was the swing vote on abortion, and all hell broke loose. The judicial confirmation process, on the point of breakdown for thirty years, now proved utterly dysfunctional. Unverified accusations of sexual assault became weapons in a ruthless campaign of personal destruction, culminating in the melodramatic hearings in which Kavanaugh’s impassioned defense resuscitated a nomination that seemed beyond saving. The Supreme Court has become the arbiter of our nation’s most vexing and divisive disputes. With the stakes of each vacancy incalculably high, the incentive to destroy a nominee is nearly irresistible. The next time a nomination promises to change the balance of the Court, Hemingway and Severino warn, the confirmation fight will be even uglier than Kavanaugh’s. A good person might accept that nomination in the naïve belief that what happened to Kavanaugh won’t happen to him because he is a good person. But it can happen, it does happen, and it just happened. The question is whether America will let it happen again.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309176611
Category : Medical
Languages : en
Pages : 279
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Book Description
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.
Author: Shivaani Kummar
Publisher: Academic Press
ISBN: 9780128125120
Category : Medical
Languages : en
Pages : 0
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Book Description
Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials.
Author: JoAnn Pfeiffer
Publisher: CRC Press
ISBN: 1315299771
Category : Mathematics
Languages : en
Pages : 292
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Book Description
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309494885
Category : Medical
Languages : en
Pages : 127
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Book Description
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
