Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Sharing Clinical Trial Data PDF full book. Access full book title Sharing Clinical Trial Data by Institute of Medicine. Download full books in PDF and EPUB format.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309253187 Category : Medical Languages : en Pages : 248
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.
Author: T. Scott Stroup Publisher: Cambridge University Press ISBN: 1139487574 Category : Medical Languages : en Pages :
Book Description
Antipsychotic medications are a key treatment for schizophrenia and sales of antipsychotic drugs approach $20 billion per year, with fierce marketing between the makers of the drugs. The U.S. National Institute of Mental Health sponsored the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project to provide independent information about the comparative effectiveness of medications. CATIE was the largest, longest and most comprehensive study of schizophrenia to date. Conducted under rigorous double-blind conditions, Antipsychotic Trials in Schizophrenia presents the definitive archival results of this landmark study. The core of the book consists of chapters focused on specific outcomes that set the CATIE findings in a wider context. Also included are chapters on the design, statistical analyses and implications for researchers, clinicians and policy makers. Psychiatrists, psychiatric researchers, mental health policy makers and those working in pharmaceutical companies will all find this to be essential reading.
Author: Agency for Health Care Research and Quality (U.S.) Publisher: Government Printing Office ISBN: 1587634236 Category : Medical Languages : en Pages : 236
Book Description
This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Author: Frank van der Linden Publisher: Springer ISBN: 3540683836 Category : Computers Languages : en Pages : 267
Book Description
This book originates from a workshop organised by ESPRIT project 20 477, ARES in Las Palmas de Gran Canaria, Spain, February 1998. ARES is an acronym for Architectural Reasoning for Embedded Systems. Within this project we investigate techniques to deal with problems of software architecture of families of embedded systems. It is the second workshop organised by this project. Its predecessor was held in Las Navas de Marques, Spain, November 1996. The proceedings of the first workshop are only available in electronic format at "http://www.dit.upm.es/~ares/". The second workshop succeeded, even more than the first one, in gathering many of the most prominent people working in the area of software architecture for product families or product lines. This second workshop consisted of six sessions. The first session was meant to report the ARES results, according to the topics of the next five sessions. The remaining sessions dealt with different aspects of software architecture, focussed on applications for product families or product lines. Because there will be a separate book covering all ARES results, the first session is not included in this book. The workshop was chaired by Henk Obbink from Philips Research and Paul Clements from the Software Engineering Institute at Carnegie Mellon University. They prepared and presented an overall conclusion at the end of the workshop. This conclusion was used in the introduction to this book.
Author: John I. Gallin Publisher: Elsevier ISBN: 0080489567 Category : Science Languages : en Pages : 447
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
Author: Felicity Smith Publisher: Pharmaceutical Press ISBN: 0853698694 Category : Medical Languages : en Pages : 241
Book Description
Research projects are a requirement of many undergraduate and postgraduate pharmacy courses. This handbook considers the stages of the research process in a logical order, from the planning of the project to the dissemination of the findings.
Author: Institute of Medicine
Author: Institute of Medicine
Author: Institute of Medicine
Author: James S. Taylor
Author: T. Scott Stroup
Author: Agency for Health Care Research and Quality (U.S.)
Author: Frank van der Linden
Author: Environmental Research Laboratories (U.S.)
Author: John I. Gallin
Author: Felicity Smith
Author: