Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Download or read book SEER Surveillance Epidemiology and End Results Program written by SEER Program (National Cancer Institute (U.S.)) and published by . This book was released on 2000 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Download or read book Clinical Applications for Next Generation Sequencing written by Urszula Demkow and published by Academic Press. This book was released on 2015-09-10 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Applications for Next Generation Sequencing provides readers with an outstanding postgraduate resource to learn about the translational use of NGS in clinical environments. Rooted in both medical genetics and clinical medicine, the book fills the gap between state-of-the-art technology and evidence-based practice, providing an educational opportunity for users to advance patient care by transferring NGS to the needs of real-world patients. The book builds an interface between genetic laboratory staff and clinical health workers to not only improve communication, but also strengthen cooperation. Users will find valuable tactics they can use to build a systematic framework for understanding the role of NGS testing in both common and rare diseases and conditions, from prenatal care, like chromosomal abnormalities, up to advanced age problems like dementia. - Fills the gap between state-of-the-art technology and evidence-based practice - Provides an educational opportunity which advances patient care through the transfer of NGS to real-world patient assessment - Promotes a practical tool that clinicians can apply directly to patient care - Includes a systematic framework for understanding the role of NGS testing in many common and rare diseases - Presents evidence regarding the important role of NGS in current diagnostic strategies

Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

Download or read book Improving Diagnosis in Health Care written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2015-12-29 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: Getting the right diagnosis is a key aspect of health care - it provides an explanation of a patient's health problem and informs subsequent health care decisions. The diagnostic process is a complex, collaborative activity that involves clinical reasoning and information gathering to determine a patient's health problem. According to Improving Diagnosis in Health Care, diagnostic errors-inaccurate or delayed diagnoses-persist throughout all settings of care and continue to harm an unacceptable number of patients. It is likely that most people will experience at least one diagnostic error in their lifetime, sometimes with devastating consequences. Diagnostic errors may cause harm to patients by preventing or delaying appropriate treatment, providing unnecessary or harmful treatment, or resulting in psychological or financial repercussions. The committee concluded that improving the diagnostic process is not only possible, but also represents a moral, professional, and public health imperative. Improving Diagnosis in Health Care, a continuation of the landmark Institute of Medicine reports To Err Is Human (2000) and Crossing the Quality Chasm (2001), finds that diagnosis-and, in particular, the occurrence of diagnostic errorsâ€"has been largely unappreciated in efforts to improve the quality and safety of health care. Without a dedicated focus on improving diagnosis, diagnostic errors will likely worsen as the delivery of health care and the diagnostic process continue to increase in complexity. Just as the diagnostic process is a collaborative activity, improving diagnosis will require collaboration and a widespread commitment to change among health care professionals, health care organizations, patients and their families, researchers, and policy makers. The recommendations of Improving Diagnosis in Health Care contribute to the growing momentum for change in this crucial area of health care quality and safety.

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.

Download or read book Companion Diagnostics CDx in Precision Medicine written by Il-Jin Kim and published by CRC Press. This book was released on 2019-03-06 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a new trend in anti-cancer therapeutics development: a targeted therapy and precision medicine that targets a subgroup of patients with specific biomarkers. An in vitro diagnostic (IVD) assay is required to identify a subgroup of cancer patients who would benefit from the targeted therapy, or not likely benefit, or have a high risk of side effects from the specific drug treatment. This IVD or medical device is called a companion diagnostic (CDx) assay. It is key to have a robust CDx assay or device for the success of targeted therapy and precision medicine. This book covers the technical, historical, clinical, and regulatory aspects of CDx in precision medicine. Clearly, more and more newly developed oncology drugs will require accompanying CDx assays, and this book, with chapters contributed by renowned oncologists, provides a comprehensive foundation for the knowledge and application of CDx for precision medicine.

Download or read book Elements of Pathology written by Aller Gustin Ellis and published by . This book was released on 1926 with total page 658 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book Molecular Diagnostics of Infectious Diseases written by Harald H. Kessler and published by Walter de Gruyter GmbH & Co KG. This book was released on 2014-07-28 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: The prevalence of infectious diseases is worldwide increasing. Therefore, detection methods for infectious pathogens change quickly. In the 3rd edition of Kessler ́s Molecular Diagnostics of Infectious Diseases laboratory professionalists get valueable information about the current diagnostic methods, tipps and tricks in terms of sample processing, quality control, and interpretation of the results. For clinicians the book is a valuable aid for decision-making in ordering appropriate tests as well as in assuring the necessary quality of the sample material.

Download or read book The Future of the Public s Health in the 21st Century written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-01 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: The anthrax incidents following the 9/11 terrorist attacks put the spotlight on the nation's public health agencies, placing it under an unprecedented scrutiny that added new dimensions to the complex issues considered in this report. The Future of the Public's Health in the 21st Century reaffirms the vision of Healthy People 2010, and outlines a systems approach to assuring the nation's health in practice, research, and policy. This approach focuses on joining the unique resources and perspectives of diverse sectors and entities and challenges these groups to work in a concerted, strategic way to promote and protect the public's health. Focusing on diverse partnerships as the framework for public health, the book discusses: The need for a shift from an individual to a population-based approach in practice, research, policy, and community engagement. The status of the governmental public health infrastructure and what needs to be improved, including its interface with the health care delivery system. The roles nongovernment actors, such as academia, business, local communities and the media can play in creating a healthy nation. Providing an accessible analysis, this book will be important to public health policy-makers and practitioners, business and community leaders, health advocates, educators and journalists.

Download or read book Transition to Diagnosis Related Group DRG Payments for Health written by Caryn Bredenkamp and published by World Bank Publications. This book was released on 2019-12-19 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines how nine different health systems--U.S. Medicare, Australia, Thailand, Kyrgyz Republic, Germany, Estonia, Croatia, China (Beijing) and the Russian Federation--have transitioned to using case-based payments, and especially diagnosis-related groups (DRGs), as part of their provider payment mix for hospital care. It sheds light on why particular technical design choices were made, what enabling investments were pertinent, and what broader political and institutional issues needed to be considered. The strategies used to phase in DRG payment receive special attention. These nine systems have been selected because they represent a variety of different approaches and experiences in DRG transition. They include the innovators who pioneered DRG payment systems (namely the United States and Australia), mature systems (such as Thailand, Germany, and Estonia), and countries where DRG payments were only introduced within the past decade (such as the Russian Federation and China). Each system is examined in detail as a separate case study, with a synthesis distilling the cross-cutting lessons learned. This book should be helpful to those working on health systems that are considering introducing, or are in the early stages of introducing, DRG-based payments into their provider payment mix. It will enhance the reader's understanding of how other countries (or systems) have made that transition, give a sense of the decisions that lie ahead, and offer options that can be considered. It will also be useful to those working in health systems that already include DRG payments in the payment mix but have not yet achieved the anticipated results.

Download or read book Clinical Genomics written by Shashikant Kulkarni and published by Academic Press. This book was released on 2014-11-10 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Genomics provides an overview of the various next-generation sequencing (NGS) technologies that are currently used in clinical diagnostic laboratories. It presents key bioinformatic challenges and the solutions that must be addressed by clinical genomicists and genomic pathologists, such as specific pipelines for identification of the full range of variants that are clinically important. This book is also focused on the challenges of diagnostic interpretation of NGS results in a clinical setting. Its final sections are devoted to the emerging regulatory issues that will govern clinical use of NGS, and reimbursement paradigms that will affect the way in which laboratory professionals get paid for the testing. - Simplifies complexities of NGS technologies for rapid education of clinical genomicists and genomic pathologists towards genomic medicine paradigm - Tried and tested practice-based analysis for precision diagnosis and treatment plans - Specific pipelines and meta-analysis for full range of clinically important variants

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.

Download or read book Precision Cancer Medicine written by Sameek Roychowdhury and published by Springer Nature. This book was released on 2020-01-02 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genomic sequencing technologies have augmented the classification of cancer beyond tissue of origin and towards a molecular taxonomy of cancer. This has created opportunities to guide treatment decisions for individual patients with cancer based on their cancer’s unique molecular characteristics, also known as precision cancer medicine. The purpose of this text will be to describe the contribution and need for multiple disciplines working together to deliver precision cancer medicine. This entails a multi-disciplinary approach across fields including molecular pathology, computational biology, clinical oncology, cancer biology, drug development, genetics, immunology, and bioethics. Thus, we have outlined a current text on each of these fields as they work together to overcome various challenges and create opportunities to deliver precision cancer medicine. As trainees and junior faculty enter their respective fields, this text will provide a framework for understanding the role and responsibility for each specialist to contribute to this team science approach.

Download or read book Healthcare Disrupted written by Jeff Elton and published by John Wiley & Sons. This book was released on 2016-02-08 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: “During a time of tremendous change and uncertainty, Healthcare Disrupted gives executives a framework and language to determine how they will evolve their products, services, and strategies to flourish in a increasingly value-based healthcare system. Using a powerful mix of real world examples and unanswered questions, Elton and O’Riordan lead you to see that ‘no action’ is not an option—and push you to answer the most important question: ‘What is your role in this digitally driven change and how can your firm can gain competitive advantage and lead?’”—David Epstein, Division Head, Novartis Pharmaceuticals “Healthcare Disrupted is an inspirational call-to-action for everyone associated with healthcare, especially the innovators who will develop the next generation of therapeutics, diagnostics, and devices.”—Bob Horvitz, Ph.D., David H. Koch Professor of Biology, MIT; Nobel Prize in Physiology or Medicine “In a time of dizzying change across all fronts: from biology, to delivery, to the use of big data, Health Disrupted captures the impact of these forces and thoughtfully develops new approaches to value creation in the healthcare industry. A must-read for those who strive to capitalize on change and reinvent the industry.”—Deborah Dunsire, M.D., president and CEO, FORUM Pharmaceuticals Healthcare at a Crossroad: Seismic Shifts, New Business Models for Success Healthcare Disrupted is an in-depth look at the disruptive forces driving change in the the healthcare industry and provides guide for defining new operating and business models in response to these profound changes. Based on original research conducted by Accenture and years of experience working with the most successful companies in the industry, healthcare experts Jeff Elton and Anne O’Riordan provide an informed, insightful view of the state of the industry, what's to come, and new emerging business models for life sciences companies play a different role from the past in to driving superior outcomes for patients and playing a bigger role in creating greater value for healthcare overall. Their book explains how critical global healthcare trends are challenging legacy strategies and business models, and examines why historical leaders in the industy must evolve, to stay relevant and compete with new entrants. Healthcare Disrupted captures this pivotal point in time to give executives and senior managers across pharmaceutical, biopharmaceutical, medical device, medical diagnostics, digital technology, and health services companies an opportunity to step back and consider the changing landscape. This book gives companies options for how to adapt and stay relevant and outlines four new business models that can drive sustainable growth and performance. It demonstrates how real-world data (from Electronic Medical Records, health wearables, Internet of Things, digital media, social media, and other sources) is combining with scalable technologies and advanced analytics to fundamentally change how and where healthcare is delivered, bridging to the health of populations, and broadening the resposibility for both. It reveals how this shift in healthcare delivery will significantly improve patient outcomes and the value health systems realize.