Integrating Clinical and Translational Research Networks—Building Team Medicine


Book Description

Medical centers are widely recognized as vital components of the healthcare system. However, academic medical centers are differentiated from their community counterparts by their mission, which typically focuses on clinical care, education, and research. Nonetheless, community clinics/hospitals fill a critical need and play a complementary role serving as the primary sites for health care in most communities. Furthermore, it is now increasingly recognized that in addition to physicians, physician-scientists, and other healthcare-related professionals, basic research scientists also contribute significantly to the emerging inter- and cross-disciplinary, team-oriented culture of translational science. Therefore, approaches that combine the knowledge, skills, experience, expertise, and visions of clinicians in academic medical centers and their affiliated community centers and hospitals, together with basic research scientists, are critical in shaping the emerging culture of translational research so that patients from the urban as well as suburban settings can avail the benefits of the latest developments in science and medicine. ‘Integrating Clinical and Translational Research Networks—Building Team Medicine’ is an embodiment of this ethos at the City of Hope National Medical Center in Duarte, California. It includes a series of papers authored by teams of leading clinicians, basic research scientists, and translational researchers. The authors discuss how engaging and collaborating with community-based practices, where the majority of older patients with cancer receive their care, can ensure that these patients receive the highest-quality, evidence-based care. Based on our collective experience at City of Hope, we would like to stress that the success of academic-community collaborative programs not only depends on the goodwill and vision of the participants but also on the medical administration, academic leadership, and policymakers who define the principles and rules by which cooperation within the health care industry occurs. We trust that our experience embodied in this singular compendium will serve as a ‘Rosetta Stone’ for other institutions and practitioners.




The CTSA Program at NIH


Book Description

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.




Exploring Novel Clinical Trial Designs for Gene-Based Therapies


Book Description

Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop.




Envisioning a Transformed Clinical Trials Enterprise in the United States


Book Description

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.




Evolution of Translational Omics


Book Description

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.




The Learning Healthcare System


Book Description

As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.




Translational Research in Traumatic Brain Injury


Book Description

Traumatic brain injury (TBI) remains a significant source of death and permanent disability, contributing to nearly one-third of all injury related deaths in the United States and exacting a profound personal and economic toll. Despite the increased resources that have recently been brought to bear to improve our understanding of TBI, the developme




Principles and Practice of Clinical Research


Book Description

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government




The Comprehensive Cancer Center


Book Description

This open access book provides a valuable resource for hospitals, institutions, and health authorities worldwide in their plans to set up and develop comprehensive cancer care centers. The development and implementation of a comprehensive cancer program allows for a systematic approach to evidence-based strategies of prevention, early detection, diagnosis, treatment, and palliation. Comprehensive cancer programs also provide a nexus for the running of clinical trials and implementation of novel cancer therapies with the overall aim of optimizing comprehensive and holistic care of cancer patients and providing them with the best opportunity to improve quality of life and overall survival. This book's self-contained chapter format aims to reinforce the critical importance of comprehensive cancer care centers while providing a practical guide for the essential components needed to achieve them, such as operational considerations, guidelines for best clinical inpatient and outpatient care, and research and quality management structures. Intended to be wide-ranging and applicable at a global level for both high and low income countries, this book is also instructive for regions with limited resources. The Comprehensive Cancer Center: Development, Integration, and Implementation is an essential resource for oncology physicians including hematologists, medical oncologists, radiation oncologists, surgical oncologists, and oncology nurses as well as hospitals, health departments, university authorities, governments and legislators.




Clinical and Basic Neurogastroenterology and Motility


Book Description

Clinical and Basic Neurogastroenterology and Motility is a state-of-the-art, lucidly written, generously illustrated, landmark publication that comprehensively addresses the underlying mechanisms and management of common adult and pediatric motility disorders. These problems affect 50% of the population and include conditions such as dysphagia, achalasia, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome (IBS), gas and bloating, SIBO, constipation and fecal incontinence. The book brings together international experts and clinician scientists, epitomizing their years of wisdom into a concise yet practical text that is delivered in two distinct sections, basic and clinical. It fulfills a large unmet need, and bridges a long-awaited knowledge gap among trainees, clinicians, scientists, nurses and technicians, earnestly engaged in this field. - First of its kind text that covers both basic and clinical aspects, bridging the knowledge gap, and providing a bench to bedside approach for management of common disorders - Discusses the latest concepts and basic principles of neurogastroenterology and motility, and how the gut and brain interact in the genesis of functional gastrointestinal and motility disorders - Provides an illustrated and practical text on hot topics written by leading adult and pediatric gastroenterology experts across the globe - Includes an accompanying more detailed web version of the text with free access to future podcasts