In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
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.
Besides love, money and health are the most valuable human yearnings. Therefore, blockchain technology is paramount: a new foundation of confidence for human valuable transactions. Like information sharing was catalyzed on the pre-blockchain internet, transactions are now triggered on the new internet of value. In this second digital inflection point, economic media encompasses value beside information, and individuals can privately transact digital assets for the first time in history. Decentralized but structured organizations running on blockchain networks reduce transaction costs and are particularly competitive insofar as they guarantee data authenticity, confidentiality, and integrity, providing functional autonomy with disintermediation and smart contracts. Everything changed after user data were made public on the internet and privately traded by big tech companies, and nothing will be the same once that data is made private on the internet and publicly transacted by their rightful owners. While the internet of information reshaped the world, the internet of value will reform it, and everything will depend politically on this being done freely. Political and Economic Implications of Blockchain Technology in Business and Healthcare provides relevant theoretical frameworks on the civilizational impact of blockchain technology, which redesigns human interactions concerning value transactions. It gives ideas, concepts, and instruments to advance the knowledge on cryptoeconomics and decentralized governance in the new distributed trust paradigm. The chapters explore the ethical repercussions and profound political-economic consequences to society, providing insights into business applications focusing on the healthcare sector. In a blockchain era affected by the post-COVID-19 new normal, which mixes politics, economics, and health, this book is essential for students and researchers in social and life sciences; professionals and policymakers working in the fields of public and business administration; and healthcare workers and researchers, academicians, and students interested in blockchain technology and its political and economic impacts in the industry and society.
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
"[This book is] the most authoritative assessment of the advantages and disadvantages of recent trends toward the commercialization of health care," says Robert Pear of The New York Times. This major study by the Institute of Medicine examines virtually all aspects of for-profit health care in the United States, including the quality and availability of health care, the cost of medical care, access to financial capital, implications for education and research, and the fiduciary role of the physician. In addition to the report, the book contains 15 papers by experts in the field of for-profit health care covering a broad range of topicsâ€"from trends in the growth of major investor-owned hospital companies to the ethical issues in for-profit health care. "The report makes a lasting contribution to the health policy literature." â€"Journal of Health Politics, Policy and Law.
Provides important new content on specific ethical, leadership, and advocacy capabilities that advance the DNP role in nursing practice This core text for the DNP curriculum encompasses all facets of the evolving advanced practice role including diverse professional opportunities and options for career advancement. With ten completely new chapters, the third edition conveys the latest developments in doctoral-level capabilities, including the specific ethical, leadership, and advocacy components that advance these roles. New content addresses health equity, role negotiation, ethical and leadership dilemmas for the clinician, and the preceptor role in relation to doctoral-level advanced practice. Considering the predominance of students seeking the Nurse Practitioner role, the book emphasizes the clinical context for the DNP along with the new AACN Domain of Professionalism. There also are contributions from Nurse Midwives, Nurse Anesthetists, Clinical Nurse Specialists, and DNPs in the Nurse Educator role. The text is distinguished by distinctive Reflective Responses to the authors of all chapters. These may be characterized as a Point-Counterpoint feature—consisting of commentaries by scholars of varying points of view—that stimulates substantive critical dialogue. It examines the role of evidence—both practice-based evidence and evidence-based practice—in the context of clinical problems and policy formation and focuses on how the doctoral advanced prepared nurse can discriminate, translate, and sometimes generate new nursing evidence. The text addresses the need for both forms of evidence and underscores the importance of innovative healthcare intervention models. Included is practical information illustrated with examples geared for both BSN-DNP students and MSN-DNP students. Content on the DNP/PhD double doctorate and the impact of DNP leadership on organizations further examines the relationship between nursing practice, education, and science. New to the Third Edition: Ten new chapters, including coverage of: COVID-19; BSN-DNP Trajectories; Practice-Based Evidence and Evidence-Based Practice; Health Equity; Role Negotiation, Ethical, Leadership, and Advocacy Roles; and 2021 AACN Essentials Expanded roles and content for students of varying experience levels Emphasis on the new AACN Domain of Professionalism throughout Key Features: Focuses on DNP role development with extensive contributions by leading DNP scholars and clinicians Delivers Reflective Responses in a Point-Counterpoint format to stimulate vigorous class discussion Provides critical thinking questions throughout including Reflective Response
The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics. - Contains a comprehensive source of principles of drug discovery and development topics, especially for scientists that are new in the pharmaceutical industry such as those with trainings/degrees in chemistry and engineering - Provides a detailed source for formulation scientists and compounding pharmacists, from produg to excipient issues - Updates this excellent source with the latest information to verify facts and refresh on basics for professionals in the broadly defined pharmaceutical industry
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
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.
