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TI has received honoraria from Eisai as a consultant and grants or funding to his institution from Novartis. TI participated in congress for which travel and accommodations were paid by Ipsen, Pharmamar, and Novartis.
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.
This revised edition covers all aspects of public health informatics and discusses the creation and management of an information technology infrastructure that is essential in linking state and local organizations in their efforts to gather data for the surveillance and prevention. Public health officials will have to understand basic principles of information resource management in order to make the appropriate technology choices that will guide the future of their organizations. Public health continues to be at the forefront of modern medicine, given the importance of implementing a population-based health approach and to addressing chronic health conditions. This book provides informatics principles and examples of practice in a public health context. In doing so, it clarifies the ways in which newer information technologies will improve individual and community health status. This book's primary purpose is to consolidate key information and promote a strategic approach to information systems and development, making it a resource for use by faculty and students of public health, as well as the practicing public health professional. Chapter highlights include: The Governmental and Legislative Context of Informatics; Assessing the Value of Information Systems; Ethics, Information Technology, and Public Health; and Privacy, Confidentiality, and Security. Review questions are featured at the end of every chapter. Aside from its use for public health professionals, the book will be used by schools of public health, clinical and public health nurses and students, schools of social work, allied health, and environmental sciences.
In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.
Essential for anyone who uses computers in clinical practice and cares about the ethical issues that arise in their work.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.
An unprecedented constellation of experts—leading cancer doctors, policymakers, cutting-edge researchers, national advocates, and more—explore the legacy and the shortcomings from the fifty-year war on cancer and look ahead to the future. The longest war in the modern era, longer than the Cold War, has been the war on cancer. Cancer is a complex, evasive enemy, and there was no quick victory in the fight against it. But the battle has been a monumental test of medical and scientific research and fundraising acumen, as well as a moral and ethical challenge to the entire system of medicine. In A New Deal for Cancer, some of today’s leading thinkers, activists, and medical visionaries describe the many successes in the long war and the ways in which our deeper failings as a society have held us back from a more complete success. Together they present an unrivaled and nearly complete map of the battlefield across dimensions of science, government, equity, business, the patient provider experience, and more, documenting our emerging understanding of cancer’s many unique dimensions and offering bold new plans to enable the American health care system to deliver progress and hope to all patients.
The study of the biology of tumours has grown to become markedly interdisciplinary, involving chemists, statisticians, epidemiologists, mathematicians, bioinformaticians, and computer scientists alongside biologists, geneticists, and clinicians. The Oxford Textbook of Cancer Biology brings together the most up-to-date developments from different branches of research into one coherent volume, providing a comprehensive and current account of this rapidly evolving field. Structured in eight sections, the book starts with a review of the development and biology of multi-cellular organisms, how they maintain a healthy homeostasis in an individual, and a description of the molecular basis of cancer development. The book then illustrates, as once cells become neoplastic, their signalling network is altered and pathological behaviour follows. It explores the changes that cancer cells can induce in nearby normal tissue, the new relationship established between them and the stroma, and the interaction between the immune system and tumour growth. The authors illustrate the contribution provided by high throughput techniques to map cancer at different levels, from genomic sequencing to cellular metabolic functions, and how information technology, with its vast amounts of data, is integrated with traditional cell biology to provide a global view of the disease. The effect of the different types of treatments on the biology of the neoplastic cells are explored to understand on the one side, why some treatments succeed, and on the other, how they can affect the biology of resistant and recurrent disease. The book concludes by summarizing what we know to date about cancer, and in what direction our understanding of cancer is moving. Edited by leading authorities in the field with an international team of contributors, this book is an essential resource for scholars and professionals working in the wide variety of sub-disciplines that make up today's cancer research and treatment community. It is written not only for consultation, but also for easy cover-to-cover reading.