Using DISSPLA at NIH

Using DISSPLA at NIH
Author: National Institutes of Health (U.S.). Division of Computer Research and Technology. Computer Center
Publisher:
Total Pages: 88
Release: 1988
Genre: Computer programs
ISBN:

Sharing Clinical Trial Data

Sharing Clinical Trial Data
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 236
Release: 2015-04-20
Genre: Medical
ISBN: 0309316324

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

The CTSA Program at NIH

The CTSA Program at NIH
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 179
Release: 2013-10-09
Genre: Medical
ISBN: 0309284740

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.

Enhancing the Effectiveness of Team Science

Enhancing the Effectiveness of Team Science
Author: National Research Council
Publisher: National Academies Press
Total Pages: 255
Release: 2015-07-15
Genre: Business & Economics
ISBN: 0309316855

The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials
Author: National Research Council
Publisher: National Academies Press
Total Pages: 163
Release: 2010-12-21
Genre: Medical
ISBN: 030918651X

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Using TELL-A-GRAF at NIH

Using TELL-A-GRAF at NIH
Author: National Institutes of Health (U.S.). Division of Computer Research and Technology. Computer Center
Publisher:
Total Pages: 100
Release: 1985
Genre: Computer graphics
ISBN:

Measuring the Quality of Health Care

Measuring the Quality of Health Care
Author: The National Roundtable on Health Care Quality
Publisher: National Academies Press
Total Pages: 42
Release: 1999-02-23
Genre: Medical
ISBN: 0309570689

The National Roundtable on Health Care Quality was established in 1995 by the Institute of Medicine. The Roundtable consists of experts formally appointed through procedures of the National Research Council (NRC) who represent both public and private-sector perspectives and appropriate areas of substantive expertise (not organizations). From the public sector, heads of appropriate Federal agencies serve. It offers a unique, nonadversarial environment to explore ongoing rapid changes in the medical marketplace and the implications of these changes for the quality of health and health care in this nation. The Roundtable has a liaison panel focused on quality of care in managed care organizations. The Roundtable convenes nationally prominent representatives of the private and public sector (regional, state and federal), academia, patients, and the health media to analyze unfolding issues concerning quality, to hold workshops and commission papers on significant topics, and when appropriate, to produce periodic statements for the nation on quality of care matters. By providing a structured opportunity for regular communication and interaction, the Roundtable fosters candid discussion among individuals who represent various sides of a given issue.

Unequal Treatment

Unequal Treatment
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 781
Release: 2009-02-06
Genre: Medical
ISBN: 030908265X

Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.

Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications
Author: United States. Superintendent of Documents
Publisher:
Total Pages: 1068
Release: 1989
Genre: Government publications
ISBN:

February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index