Sharing clinical trial data: maximizing benefits, minimizing risk
Gespeichert in:
Format: | Elektronisch E-Book |
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Sprache: | Undetermined |
Veröffentlicht: |
Washington, DC
The National Academies Press
[2015]
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Schlagworte: | |
Online-Zugang: | TUM01 Volltext |
Beschreibung: | 1 Online-Ressource |
ISBN: | 9780309316309 0309316308 9780309316293 0309316294 |
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505 | 8 | |a Introduction -- Guiding principles for sharing clinical trial data -- The roles and responsibilities of stakeholders in the sharing of clinical trial data -- The clinical trial life cycle and when to share data -- Access to clinical trial data: governance -- The future of data sharing in a changing landscape -- Study approach -- Concepts and methods for de-identifying clinical trial data -- Legal discussion of risks to industry sponsors -- Clinical trial data sharing policies: top 12 pharmaceutical companies ranked by 2013 market capitalization | |
505 | 8 | |a "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." | |
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Datensatz im Suchindex
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contents | Includes bibliographical references Introduction -- Guiding principles for sharing clinical trial data -- The roles and responsibilities of stakeholders in the sharing of clinical trial data -- The clinical trial life cycle and when to share data -- Access to clinical trial data: governance -- The future of data sharing in a changing landscape -- Study approach -- Concepts and methods for de-identifying clinical trial data -- Legal discussion of risks to industry sponsors -- Clinical trial data sharing policies: top 12 pharmaceutical companies ranked by 2013 market capitalization "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." |
ctrlnum | (ZDB-4-NLEBK)991085 (OCoLC)904734999 (DE-599)BVBBV042792280 |
dewey-full | 610.285 |
dewey-hundreds | 600 - Technology (Applied sciences) |
dewey-ones | 610 - Medicine and health |
dewey-raw | 610.285 |
dewey-search | 610.285 |
dewey-sort | 3610.285 |
dewey-tens | 610 - Medicine and health |
discipline | Medizin |
format | Electronic eBook |
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spelling | Sharing clinical trial data maximizing benefits, minimizing risk Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies Washington, DC The National Academies Press [2015] 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier Includes bibliographical references Introduction -- Guiding principles for sharing clinical trial data -- The roles and responsibilities of stakeholders in the sharing of clinical trial data -- The clinical trial life cycle and when to share data -- Access to clinical trial data: governance -- The future of data sharing in a changing landscape -- Study approach -- Concepts and methods for de-identifying clinical trial data -- Legal discussion of risks to industry sponsors -- Clinical trial data sharing policies: top 12 pharmaceutical companies ranked by 2013 market capitalization "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." HEALTH & FITNESS / Holism bisacsh HEALTH & FITNESS / Reference bisacsh MEDICAL / Alternative Medicine bisacsh MEDICAL / Atlases bisacsh MEDICAL / Essays bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Holistic Medicine bisacsh MEDICAL / Osteopathy bisacsh Datenverarbeitung Medizin Clinical trials Data processing 1\p (DE-588)1071861417 Konferenzschrift gnd-content Institute of Medicine (Washington, DC) Board on Health Sciences Policy Sonstige (DE-588)5539682-3 oth http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=991085 Aggregator Volltext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
spellingShingle | Sharing clinical trial data maximizing benefits, minimizing risk Includes bibliographical references Introduction -- Guiding principles for sharing clinical trial data -- The roles and responsibilities of stakeholders in the sharing of clinical trial data -- The clinical trial life cycle and when to share data -- Access to clinical trial data: governance -- The future of data sharing in a changing landscape -- Study approach -- Concepts and methods for de-identifying clinical trial data -- Legal discussion of risks to industry sponsors -- Clinical trial data sharing policies: top 12 pharmaceutical companies ranked by 2013 market capitalization "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." HEALTH & FITNESS / Holism bisacsh HEALTH & FITNESS / Reference bisacsh MEDICAL / Alternative Medicine bisacsh MEDICAL / Atlases bisacsh MEDICAL / Essays bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Holistic Medicine bisacsh MEDICAL / Osteopathy bisacsh Datenverarbeitung Medizin Clinical trials Data processing |
subject_GND | (DE-588)1071861417 |
title | Sharing clinical trial data maximizing benefits, minimizing risk |
title_auth | Sharing clinical trial data maximizing benefits, minimizing risk |
title_exact_search | Sharing clinical trial data maximizing benefits, minimizing risk |
title_full | Sharing clinical trial data maximizing benefits, minimizing risk Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
title_fullStr | Sharing clinical trial data maximizing benefits, minimizing risk Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
title_full_unstemmed | Sharing clinical trial data maximizing benefits, minimizing risk Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies |
title_short | Sharing clinical trial data |
title_sort | sharing clinical trial data maximizing benefits minimizing risk |
title_sub | maximizing benefits, minimizing risk |
topic | HEALTH & FITNESS / Holism bisacsh HEALTH & FITNESS / Reference bisacsh MEDICAL / Alternative Medicine bisacsh MEDICAL / Atlases bisacsh MEDICAL / Essays bisacsh MEDICAL / Family & General Practice bisacsh MEDICAL / Holistic Medicine bisacsh MEDICAL / Osteopathy bisacsh Datenverarbeitung Medizin Clinical trials Data processing |
topic_facet | HEALTH & FITNESS / Holism HEALTH & FITNESS / Reference MEDICAL / Alternative Medicine MEDICAL / Atlases MEDICAL / Essays MEDICAL / Family & General Practice MEDICAL / Holistic Medicine MEDICAL / Osteopathy Datenverarbeitung Medizin Clinical trials Data processing Konferenzschrift |
url | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=991085 |
work_keys_str_mv | AT instituteofmedicinewashingtondcboardonhealthsciencespolicy sharingclinicaltrialdatamaximizingbenefitsminimizingrisk |