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.

There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities. * Provides a practical overview of data monitoring in clinical trials. * Describes the purpose, responsibilities and operation of data monitoring committees. * Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees. * Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees. * Discusses issues pertinent to those working in clinical trials in both the US and Europe. The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

The Committee on the Future of Supercomputing was tasked to assess prospects for supercomputing technology research and development in support of U.S. needs, to examine key elements of context-the history of supercomputing, the erosion of research investment, the changing nature of problems demanding supercomputing, and the needs of government agencies for supercomputing capabilities-and to assess options for progress. This interim report establishes context-including the history and current state of supercomputing, application requirements, technology evolution, the socioeconomic context-to identify some of the issues that may be explored in more depth in the second phase of the study.

The need to manage, analyze, and extract knowledge from data is pervasive across industry, government, and academia. Scientists, engineers, and executives routinely encounter enormous volumes of data, and new techniques and tools are emerging to create knowledge out of these data, some of them capable of working with real-time streams of data. The nation's ability to make use of these data depends on the availability of an educated workforce with necessary expertise. With these new capabilities have come novel ethical challenges regarding the effectiveness and appropriateness of broad applications of data analyses. The field of data science has emerged to address the proliferation of data and the need to manage and understand it. Data science is a hybrid of multiple disciplines and skill sets, draws on diverse fields (including computer science, statistics, and mathematics), encompasses topics in ethics and privacy, and depends on specifics of the domains to which it is applied. Fueled by the explosion of data, jobs that involve data science have proliferated and an array of data science programs at the undergraduate and graduate levels have been established. Nevertheless, data science is still in its infancy, which suggests the importance of envisioning what the field might look like in the future and what key steps can be taken now to move data science education in that direction. This study will set forth a vision for the emerging discipline of data science at the undergraduate level. This interim report lays out some of the information and comments that the committee has gathered and heard during the first half of its study, offers perspectives on the current state of data science education, and poses some questions that may shape the way data science education evolves in the future. The study will conclude in early 2018 with a final report that lays out a vision for future data science education.

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

American study programs in China were assessed, based on interviews with American undergraduate or graduate students studying or doing research at various China institutions during the 1980-81 academic year and with Chinese administrators from the institutions. Four channels exist through which American students can arrange placement in China: national competition, institution-to-institution links, individual application (either to a Chinese university or the Ministry of Education), and short-term study programs packaged in the United States. Somewhere between 70 and 100 formal exchange agreements to facilitate the sharing of academic resources have been concluded between U.S. and Chinese institutions. A list of American institutions reporting such agreements is appended. Data are presented on the distribution of American students at Chinese universities during the 1980-81 academic year (excluding short-term language programs). In all the arrangements (except for the summer language programs), the majority of those going to China are American graduate students who are either taking coursework or doing dissertation research. Several small groups of undergraduates participate during the academic year, mainly in language programs. A summary is presented on general curricula, language classes, research difficulties, and field research. In addition, the following concerns are addressed: socializing with Chinese, housing, travel, supervision of students, university administration, credit and grading, and summer language programs. Appended materials include: U.S.-Chinese Institutional agreements, summer language programs in China, and a bibliography on U.S-China educational exchange. (SW)