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Prescription Drugs Fda Guidance And Regulations Related To Data On Elderly Persons In Clinical Drug Trials
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Book Synopsis Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials by :
Download or read book Prescription Drugs: FDA Guidance and Regulations Related to Data on Elderly Persons in Clinical Drug Trials written by and published by DIANE Publishing. This book was released on with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author :United States. Federal Trade Commission. Bureau of Consumer Protection Publisher : ISBN 13 : Total Pages :32 pages Book Rating :4.:/5 (31 download)
Book Synopsis Dietary Supplements by : United States. Federal Trade Commission. Bureau of Consumer Protection
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309672104 Total Pages :427 pages Book Rating :4.3/5 (96 download)
Book Synopsis Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis by : National Academies of Sciences, Engineering, and Medicine
Download or read book Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.
Book Synopsis Legal Aspects of Elder Care by : Marshall Kapp
Download or read book Legal Aspects of Elder Care written by Marshall Kapp and published by Jones & Bartlett Learning. This book was released on 2010-10-25 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: A wide variety of legal issues surround caring for older individuals. Health and human service practioners need to plan, provide and evaluate geriatric care, while also understanding public policies. Legal knowledge is an essential part of caring for the elderly. Students and professionals must be able to deliver appropriate care while also being aware of any legal, ethical and pilitical issues that may arise. Legal Aspects of Elder Care provides a clear overview of geriatric policies and laws, enabling the reader to use informed decision-making with older clients.
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 High-Risk Series by : Gene L. Dodaro
Download or read book High-Risk Series written by Gene L. Dodaro and published by DIANE Publishing. This book was released on 2009-12 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fed. gov¿t. is the world's largest and most complex entity, with about $3 trillion in outlays in FY 2008. Reports on high-risk areas bring focus to areas needing attention due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement. These reports also identify areas needing transformation to address major economy, efficiency, or effectiveness challenges. This 2009 update presents the status of high-risk areas listed in 2007 and identifies new high-risk areas. Solutions to high-risk problems offer the potential to save billions of dollars, dramatically improve service to the public, strengthen confidence and trust in the performance and accountability of the U.S. gov¿t., and ensure the ability of gov¿t. to deliver on its promises. Illus.
Book Synopsis Reinventing Regulation of Drugs and Medical Devices by : Bill Clinton
Download or read book Reinventing Regulation of Drugs and Medical Devices written by Bill Clinton and published by . This book was released on 1995 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis A History and Theory of Informed Consent by : Ruth R. Faden
Download or read book A History and Theory of Informed Consent written by Ruth R. Faden and published by Oxford University Press, USA. This book was released on 1986 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: A timely, authoritative discussion of an important clincial topic, this useful book outlines the history, function, nature and requirements of informed consent, focusing on patient autonomy as central to the concept. Primarily a philosophical analysis, the book also covers legal aspects, with chapters on disclosure, comprehension, and competence.
Book Synopsis FDA Nutrition Labeling Manual by : United States. Food and Drug Administration
Download or read book FDA Nutrition Labeling Manual written by United States. Food and Drug Administration and published by . This book was released on 1993 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gives generic instructions for developing and preparing an acceptable data base when valid estimates of nutrient content and variation are not available for the food (single or mixed products) to be labeled. The purpose of the manual is to advise the food industry in developing nutrition labels for food products that must comply with the regulations and to assist health professionals in interpreting nutrition labels on food products.
Book Synopsis Food and Drug Administration Modernization Act of 1997 by : United States. Congress
Download or read book Food and Drug Administration Modernization Act of 1997 written by United States. Congress and published by . This book was released on 1997 with total page 106 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Book Synopsis The Social Impact of AIDS in the United States by : National Research Council
Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis In Vitro-In Vivo Correlations by : David B. Young
Download or read book In Vitro-In Vivo Correlations written by David B. Young and published by Springer Science & Business Media. This book was released on 2013-03-08 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.
