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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309301718 Category : Medical Languages : en Pages : 98
Book Description
Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together. Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309301718 Category : Medical Languages : en Pages : 98
Book Description
Scientific advances such as the sequencing of the human genome have created great promise for improving human health by providing a greater understanding of disease biology and enabling the development of new drugs, diagnostics, and preventive services. However, the translation of research advances into clinical applications has so far been slower than anticipated. This is due in part to the complexity of the underlying biology as well as the cost and time it takes to develop a product. Pharmaceutical companies are adapting their business models to this new reality for product development by placing increasing emphasis on leveraging alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. These collaborative efforts make it possible to identify new drug targets, enhance the understanding of the underlying basis of disease, discover novel indications for the use of already approved products, and develop biomarkers for disease outcomes or directed drug use. While the potential benefits of collaboration are significant, the fact that the relationships among development partners are often financial means that it is vital to ensure trust by identifying, disclosing, and managing any potential sources of conflict that could create bias in the research being performed together. Conflict of Interest and Medical Innovation is the summary of a workshop convened by the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health in June 2013 to explore the appropriate balance between identifying and managing conflicts of interest and advancing medical innovation. A wide range of stakeholders, including government officials, pharmaceutical company representatives, academic administrators and researchers, health care providers, medical ethicists, patient advocates, and consumers, were invited to present their perspectives and participate in discussions during the workshop. This report focuses on current conflict of interest policies and their effect on medical innovation in an effort to identify best practices and potential solutions for facilitating innovation while still ensuring scientific integrity and public trust.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309145449 Category : Medical Languages : en Pages : 436
Book Description
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.
Author: Thomas P. Stossel Publisher: Rowman & Littlefield ISBN: 1442244631 Category : Medical Languages : en Pages : 355
Book Description
For millennia, human survival depended on our innate abilities to fight pathogens and repair injuries. Only recently has medical science prolonged longevity and improved quality of life. Physicians and academic researchers contribute to such progress, but the principal contributor is private industry that produces the tools – drugs and medical devices – enabling doctors to prevent and cure disease. Heavy regulation and biology’s complexity and unpredictability make medical innovation extremely difficult and expensive. Pharmaphobia describes how an ideological crusade, stretching over the last quarter century, has used distortion and flawed logic to make medical innovation even harder in a misguided pursuit of theoretical professional purity. Bureaucrats, reporters, politicians, and predatory lawyers have built careers attacking the medical products industry, belittling its critical contributions to medical innovation and accusing it of non-existent malfeasance: overselling product value, flaunting safety and corrupting physicians and academics who partner with it. The mania has imposed “conflict-of-interest” regulations limiting or banning valuable interactions between industry and physicians and researchers and diverting scarce resources from innovation to compliance. The victims are patients suffering from cancer, dementia, and other serious diseases for which new treatments are delayed, reduced, or eliminated as a result of these pointless regulations. With breathtaking detail, Thomas Stossel shows how this attack on doctors who work with industry limits medical innovation and inhibits the process of bringing new products into medical care.
Author: Thomas P. Stossel Publisher: Rowman & Littlefield Publishers ISBN: 9780810895928 Category : Conflict of interests Languages : en Pages : 352
Book Description
While plenty can be said about the dysfunction of our health care system, rarely do business and private players in health care innovation get a good rap. This book takes on skeptics of the partnership between the medical community, political groups, and private businesses, by illustrating how such cooperation can result in world-class innovation and health care delivery.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309183200 Category : Medical Languages : en Pages : 112
Book Description
The objective of the workshop that is the subject of this summary report was to present the challenges and opportunities for medical devices as perceived by the key stakeholders in the field. The agenda, and hence the summaries of the presentations that were made in the workshop and which are presented in this summary report, was organized to first examine the nature of innovation in the field and the social and economic infrastructure that supports such innovation. The next objective was to identify and discuss the greatest unmet clinical needs, with a futuristic view of technologies that might meet those needs. And finally, consideration was given to the barriers to the application of new technologies to meet clinical needs.
Author: Kevin E. Behrns Publisher: Academic Press ISBN: 0128149272 Category : Science Languages : en Pages : 286
Book Description
Medical Innovation: Concept to Commercialization is a practical, step-by-step approach on how to move a novel concept through development to realize a commercially successful product. Real-world experience cases and knowledgeable contributors provide lessons that cover the practices of diverse organizations and multiple products. This important reference will help improve success and avoid innovation failure for translational researchers, entrepreneurs, medical school educators, biomedical engineering students and faculty, and aspiring physicians. Provides multiple considerations and comprehensive lessons from varied organizations, researchers and products Designed to help address topics that improve success and avoid the high cost of innovation failure Recommends the practical steps needed to move a novel, non-developed concept into a tangible, realistic and commercially successful product
Author: Dimitri Uzunidis Publisher: John Wiley & Sons ISBN: 1786307014 Category : Business & Economics Languages : en Pages : 338
Book Description
Innovation, in economic activity, in managerial concepts and in engineering design, results from creative activities, entrepreneurial strategies and the business climate. Innovation leads to technological, organizational and commercial changes, due to the relationships between enterprises, public institutions and civil society organizations. These innovation networks create new knowledge and contribute to the dissemination of new socio-economic and technological models, through new production and marketing methods. Innovation Economics, Engineering and Management Handbook 2 is the second of the two volumes that comprise this book. The main objectives across both volumes are to study the innovation processes in todays information and knowledge society; to analyze how links between research and business have intensified; and to discuss the methods by which innovation emerges and is managed by firms, not only from a local perspective but also a global one. The studies presented in these two volumes contribute toward an understanding of the systemic nature of innovations and enable reflection on their potential applications, in order to think about the meaning of growth and prosperity
Author: Scott R. Steele Publisher: Springer ISBN: 3319259709 Category : Medical Languages : en Pages : 1269
Book Description
This third edition text provides a completely revised and updated new version of this unique, modern, practical text that covers the strategic evaluation, specific approaches, and detailed management techniques utilized by expert colorectal surgeons caring for patients with complex problems–whether they result from underlying colorectal disease or from complications arising from previous surgical therapy. The format follows that of both a “how to” manual as well as an algorithm-based guide to allow the reader to understand the thought process behind the proposed treatment strategy. By making use of evidence-based recommendations, each chapter includes not only background information and diagnostic/therapeutic guidelines, but also provides a narrative by the author on his/her operative technical details and perioperative “tips and tricks” that they utilize in the management of these complex surgical challenges. Distinctive to this book, is the reliance on experts in the field including past presidents of the ASCRS, as well as multiple other national and internationally recognized surgeons, to lend their personal insight into situations where data may be more sparse, but individual and collective experience is paramount to making sound decisions and thereby optimizing patient outcomes. The text includes chapters on the assessment of risk and methods utilized to minimize perioperative complications. In addition, it incorporates sections covering the medical and surgical therapies for abdominal, pelvic and anorectal disease. Moreover, the technical challenges of managing complications resulting from the original or subsequent operations is addressed. The underlying focus throughout the text is on providing pragmatic and understandable solutions that can be readily implemented by surgeons of varying experience to successfully treat complex colorectal problems. However, it also goes beyond the technical aspects of colorectal surgery and includes special sections highlighting the essence of a surgeon; covering aspects involving the medical-legal, ethical, and economic challenges confronting surgeons. Throughout the text, each author provides an ongoing narrative of his/her individual surgical techniques along with illustrations and diagrams to “personally” take the reader through the crucial steps of the procedure, and key points of patient care inherent to that topic. Additionally, where appropriate, links to online videos give the reader an up-front look into technical aspects of colorectal surgery.
Author: Daniel Messelken Publisher: Springer Nature ISBN: 3030363198 Category : Philosophy Languages : en Pages : 267
Book Description
This book discusses ethical questions surrounding research and innovation in military and humanitarian contexts. It focuses on human enhancement in the military. Recently, the availability of medical enhancement designed to make soldiers more capable of surviving during conflict, as well as enabling them to defeat their enemies, has emerged. Innovation and medical research in military and humanitarian contexts may thus yield positive effects, but simultaneously leads to a number of highly problematic ethical issues. The work contains contributions on medical ethics that take into account the specific roles and obligations of military and humanitarian health care providers and the ethical problems they encounter. They cover different aspects of research and innovation such as vaccine development, medical enhancement, compassionate and experimental drug use, research and application of new technologies such as wearables, “Humanitarian innovation” to cope with scarce resources, Biometrics, big data, etc.The book is of interest and importance to researchers and policy makers involved with human enhancement, medical research, and innovation in military and humanitarian missions.
Author: Margaret L. Eaton Publisher: JHU Press ISBN: 0801891949 Category : Medical Languages : en Pages : 188
Book Description
This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Institute of Medicine
Author: Thomas P. Stossel
Author: Thomas P. Stossel
Author: Institute of Medicine
Author: Kevin E. Behrns
Author: Dimitri Uzunidis
Author: Scott R. Steele
Author: Daniel Messelken
Author: Margaret L. Eaton