Download or read book Phase 1 Program Joint Report written by and published by . This book was released on 1999 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each of the Phase 1 Program Joint Working Groups describes the organizational structure and work processes that they used during the program, joint accomplishments, lessons learned, and applications to the International Space Station Program.
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Phase 1 Program Joint Report written by National Aeronautics Administration and published by CreateSpace. This book was released on 2013-10 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report consists of inputs from each of the Phase 1 Program Joint Working Groups. Most of the material was written and agreed to during a Team 0 Management Working Group Meeting at the NASA Johnson Space Center, July 13-16, 1998. For this report, the Working Groups were tasked to describe the organizational structure and work processes that they used during the program, joint accomplishments, lessons learned, and applications to the International Space Station Program. The primary authors for each section are listed at the beginning of the section, along with a list of the members of the related Working Group. At the conclusion of the meeting, the Russian and American Working Group Chairmen, or their designated representatives, approved the technical content of their sections. Editing of the report has primarily been limited to formatting and layout changes. Although having multiple authors resulted in some overlap and style differences between the sections, it offered the significant advantage that each subject area write-up was prepared and approved by the appropriate technical experts. The report is intended to be a top-level joint reference document that contains information of interest to both countries.
Download or read book Evaluation of the Congressionally Directed Medical Research Programs Review Process written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-12-19 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Phase I Oncology Drug Development written by Timothy A. Yap and published by Springer Nature. This book was released on 2020-09-16 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a detailed review of how oncology drug development has changed over the past decade, and serves as a comprehensive guide for the practicalities in setting up phase I trials. The book covers strategies to accelerate the development of novel antitumor compounds from the laboratory to clinical trials and beyond through the use of innovative mechanism-of-action pharmacodynamic biomarkers and pharmacokinetic studies. The reader will learn about all aspects of modern phase I trial designs, including the incorporation of precision medicine strategies, and approaches for rational patient allocation to novel anticancer therapies. Circulating biomarkers to assess mechanisms of response and resistance are changing the way we are assessing patient selection and are also covered in this book. The development of the different classes of antitumor agents are discussed, including chemotherapy, molecularly targeted agents, immunotherapies and also radiotherapy. The authors also discuss the lessons that the oncology field has learnt from the development of hematology-oncology drugs and how such strategies can be carried over into therapies for solid tumors. There is a dedicated chapter that covers the specialized statistical approaches necessary for phase I trial designs, including novel Bayesian strategies for dose escalation. This volume is designed to help clinicians better understand phase I clinical trials, but would also be of use to translational researchers (MDs and PhDs), and drug developers from academia and industry interested in cancer drug development. It could also be of use to phase I trial study coordinators, oncology nurses and advanced practice providers. Other health professionals interested in the treatment of cancer will also find this book of great value.
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Life in Space written by Maura Phillips Mackowski and published by University Press of Florida. This book was released on 2022-05-24 with total page 269 pages. Available in PDF, EPUB and Kindle. Book excerpt: A little-known yet critical part of NASA history Life in Space explores the many aspects and outcomes of NASA’s research in life sciences, a little-understood endeavor that has often been overlooked in histories of the space agency. Maura Mackowski details NASA’s work in this field from spectacular promises made during the Reagan era to the major new directions set by George W. Bush’s Vision for Space Exploration in the early twenty-first century. At the first flight of NASA’s space shuttle in 1981, hopes ran high for the shuttle program to achieve its potential of regularly transporting humans, cargo, and scientific experiments between Earth and the International Space Station. Mackowski describes different programs, projects, and policies initiated across NASA centers and headquarters in the following decades to advance research into human safety and habitation, plant and animal biology, and commercial biomaterials. Mackowski illuminates these ventures in fascinating detail by drawing on rare archival sources, oral histories, interviews, and site visits. While highlighting significant achievements and innovations such as space radiation research and the Neurolab Spacelab Mission, Mackowski reveals frustrations—lost opportunities, stagnation, and dead ends—stemming from frequent changes in presidential administrations and policies. For today’s dreams of lunar outposts or long-term spaceflight to become reality, Mackowski argues, a robust program in space life sciences is essential, and the history in this book offers lessons to help prevent leaving more expectations unfulfilled.
Download or read book Highway Safety Literature written by and published by . This book was released on 1977 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Challenges of Human Space Exploration written by Marsha Freeman and published by Springer Science & Business Media. This book was released on 2000-06-14 with total page 790 pages. Available in PDF, EPUB and Kindle. Book excerpt: This well illustrated, non-technical book focuses on astronauts' descriptions of the human aspects of space exploration, and their attempts to solve both mechanical and interpersonal problems. Based on interviews granted to the author by three astronauts, the book describes the experiments they undertook during the Apollo/Soyuz and Shuttle-Mir programs and the lessons learned from these missions. This book provides unique insight as to how adversity and challenges are overcome in the process of exploration.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Physical Activity and Cancer written by Kerry S. Courneya and published by Springer Science & Business Media. This book was released on 2010-11-26 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores in depth the relation between physical activity and cancer control, including primary prevention, coping with treatments, recovery after treatments, long-term survivorship, secondary prevention, and survival. The first part of the book presents the most recent research on the impact of physical activity in preventing a range of cancers. In the second part, the association between physical activity and cancer survivorship is addressed. The effects of physical activity on supportive care endpoints (e.g., quality of life, fatigue, physical functioning) and disease endpoints (e.g., biomarkers, recurrence, survival) are carefully analyzed. In addition, the determinants of physical activity in cancer survivors are discussed, and behavior change strategies for increasing physical activity in cancer survivors are appraised. The final part of the book is devoted to special topics, including the relation of physical activity to pediatric cancer survivorship and to palliative cancer care.
Download or read book Wheels Stop written by Rick Houston and published by U of Nebraska Press. This book was released on 2020-04-01 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Humanity's first reusable spacecraft and the most complex machine ever built, NASA's Space Shuttle debuted with great promise and as a dependable source of wonder and national pride. But with the Challenger catastrophe in 1986, the whole Space Shuttle program came into question, as did NASA itself, so long an institution that was seemingly above reproach. Wheels Stop tells the stirring story of how, after the Challenger disaster, the Space Shuttle not only recovered but went on to perform its greatest missions. From the Return to Flight mission of STS-26 in 1988 to the last shuttle mission ever on STS-135 in 2011, Wheels Stop takes readers behind the scenes as the shuttle's crews begin to mend Cold War tensions with the former Soviet Union, conduct vital research, deploy satellites, repair the Hubble Space Telescope, and assist in constructing the International Space Station. It also tells the heart-wrenching story of the Columbia tragedy and the loss of the magnificent STS-107 crew. As complex as the shuttle was, the people it carried into orbit were often more so--and this is their story, too. Close encounters with astronauts, flight controllers, and shuttle workers capture the human side of the Space Shuttle's amazing journey--and invite readers along for the ride. Browse more spaceflight books atupinspace.org. Purchase the audio edition.
Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1995 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lists citations with abstracts for aerospace related reports obtained from world wide sources and announces documents that have recently been entered into the NASA Scientific and Technical Information Database.
Download or read book Energy Research Abstracts written by and published by . This book was released on 1978 with total page 1190 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Energy Abstracts for Policy Analysis written by and published by . This book was released on 1988 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt:
