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.




NIH Extramural Center Programs


Book Description

Grants for research centers located in universities, medical centers, and other nonprofit research institutions account for about 9 percent of the National Institutes of Health budget. Centers are popular because they can bring visibility, focus, and increased resources to bear on specific diseases. However, congressional debate in 2001 over proposed legislation directing NIH to set up centers for muscular dystrophy research highlighted several areas of uncertainty about how to decide when centers are an appropriate research mechanism in specific cases. The debate also highlighted a growing trend among patient advocacy groups to regard centers as a key element of every disease research program, regardless of how much is known about the disease in question, the availability of experienced researchers, and other factors. This book examines the criteria and procedures used in deciding whether to establish new specialized research centers. It discusses the future role of centers in light of the growing trend of large-scale research in biomedicine, and it offers recommendations for improving the classification and tracking of center programs, clarifying and improving the decision process and criteria for initiating center programs, resolving the occasional disagreements over the appropriateness of centers, and evaluating the performance of center programs more regularly and systematically.




Managing the NIH Bethesda Campus Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment


Book Description

The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. Founded in the late 1870s, NIH has produced extraordinary advances in the treatment of common and rare diseases and leads the world in biomedical research. It is a critical national resource that plays an important role in supporting national security. The 310-acre Bethesda campus supports some 20,000 employees and contractors, and it contains more than 12 million square feet of facilities divided amongst nearly 100 buildings, including the largest dedicated research hospital in the world. The Bethesda campus supports some of the most sophisticated and groundbreaking biomedical research in the world. However, while some new state-of-the-art buildings have been constructed in recent years, essential maintenance for many facilities and the campus overall has been consistently deferred for many years. The deteriorating condition of NIH's built environment is now putting its ability to fulfill its mission at substantial risk. Managing the NIH Bethesda Campus's Capital Assets for Success in a Highly Competitive Global Biomedical Research Environment identifies the facilities in greatest need of repair on the Bethesda campus and evaluates cost estimates to determine what investment is needed for the NIH to successfully accomplish its mission going forward.




Assessment of NIH Minority Research and Training Programs


Book Description

This report provides an assessment of NIH's programs for increasing the participation in biomedical science of individuals from underrepresented minority groups. The report examines, using available data and the results of a survey of NIH trainees, the characteristics and outcomes of programs at the undergraduate, graduate, postdoctoral, and junior faculty levels. The report provides recommendations for improving these programs and their administration. It also recommends how NIH can improve the data it collects on trainees in all NIH research training programs so as to enhance training program evaluation.







The Role of NIH in Drug Development Innovation and Its Impact on Patient Access


Book Description

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.




Evaluation of the Congressionally Directed Medical Research Programs Review Process


Book Description

The medical research landscape in the United States is supported by a variety of organizations that spend billions of dollars in government and private funds each year to seek answers to complex medical and public health problems. The largest government funder is the National Institutes of Health (NIH), followed by the Department of Defense (DoD). Almost half of DoD's medical research funding is administered by the Congressionally Directed Medical Research Programs (CDMRP). The mission of CDMRP is to foster innovative approaches to medical research in response to the needs of its stakeholdersâ€"the U.S. military, their families, the American public, and Congress. CDMRP funds medical research to be performed by other government and nongovernmental organizations, but it does not conduct research itself. The major focus of CDMRP funded research is the improved prevention, diagnosis, and treatment of diseases, injuries, or conditions that affect service members and their families, and the general public. The hallmarks of CDMRP include reviewing applications for research funding using a two-tiered review process, and involving consumers throughout the process. Evaluation of the Congressionally Directed Medical Research Programs Review Process evaluates the CDMRP two-tiered peer review process, its coordination of research priorities with NIH and the Department of Veterans Affairs, and provides recommendations on how the process for reviewing and selecting studies can be improved.




Large-Scale Biomedical Science


Book Description

The nature of biomedical research has been evolving in recent years. Technological advances that make it easier to study the vast complexity of biological systems have led to the initiation of projects with a larger scale and scope. In many cases, these large-scale analyses may be the most efficient and effective way to extract functional information from complex biological systems. Large-Scale Biomedical Science: Exploring Strategies for Research looks at the role of these new large-scale projects in the biomedical sciences. Though written by the National Academies' Cancer Policy Board, this book addresses implications of large-scale science extending far beyond cancer research. It also identifies obstacles to the implementation of these projects, and makes recommendations to improve the process. The ultimate goal of biomedical research is to advance knowledge and provide useful innovations to society. Determining the best and most efficient method for accomplishing that goal, however, is a continuing and evolving challenge. The recommendations presented in Large-Scale Biomedical Science are intended to facilitate a more open, inclusive, and accountable approach to large-scale biomedical research, which in turn will maximize progress in understanding and controlling human disease.




Spinal Cord Injury


Book Description

An estimated 11,000 spinal cord injuries occur each year in the United States and more than 200,000 Americans suffer from maladies associated with spinal cord injury. This includes paralysis, bowel and bladder dysfunction, sexual dysfunction, respiratory impairment, temperature regulation problems, and chronic pain. During the last two decades, longstanding beliefs about the inability of the adult central nervous system to heal itself have been eroded by the flood of new information from research in the neurosciences and related fields. However, there are still no cures and the challenge of restoring function in the wake of spinal cord injuries remains extremely complex. Spinal Cord Injury examines the future directions for research with the goal to accelerate the development of cures for spinal cord injuries. While many of the recommendations are framed within the context of the specific needs articulated by the New York Spinal Cord Injury Research Board, the Institute of Medicine's panel of experts looked very broadly at research priorities relating to future directions for the field in general and make recommendations to strengthen and coordinate the existing infrastructure. Funders at federal and state agencies, academic organizations, pharmaceutical and device companies, and non-profit organizations will all find this book to be an essential resource as they examine their opportunities.