Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 22
Book Description
National Cancer Institute Investigational Drug Accountability Record
Author: National Cancer Institute Investigational Drug Accountability Record
Author: Investigational Drug Accountability
Author: A National Cancer Clinical Trials System for the 21st Century
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309157870
Category : Medical
Languages : en
Pages : 317
Book Description
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309065941
Category : Medical
Languages : en
Pages : 89
Book Description
In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Sharing Clinical Trial Data
Author: Institute of MedicinePublisher: 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.
Monthly Catalog of United States Government Publications
Author: Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1240
Book Description
Monthly Catalogue, United States Public Documents
Author: Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 504
Book Description
Investigator's Handbook
Author: National Cancer Institute (U.S.). Cancer Therapy Evaluation ProgramPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 166
Book Description
Federal Register
Author: Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 484
Book Description