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Titlebook: Data Monitoring in Clinical Trials; A Case Studies Appro David L. DeMets,Curt D. Furberg,Lawrence M. Friedm Book 2006 Springer-Verlag New Y

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發(fā)表于 2025-3-21 18:25:16 | 只看該作者 |倒序?yàn)g覽 |閱讀模式
書目名稱Data Monitoring in Clinical Trials
副標(biāo)題A Case Studies Appro
編輯David L. DeMets,Curt D. Furberg,Lawrence M. Friedm
視頻videohttp://file.papertrans.cn/263/262983/262983.mp4
概述From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998
圖書封面Titlebook: Data Monitoring in Clinical Trials; A Case Studies Appro David L. DeMets,Curt D. Furberg,Lawrence M. Friedm Book 2006 Springer-Verlag New Y
描述.Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented...This book should be useful to anyone serving on a data and sa
出版日期Book 2006
關(guān)鍵詞Division; Host; LDA; Statistica; complexity; design; eXist; evaluation; form; monitor; monitoring; object; repor
版次1
doihttps://doi.org/10.1007/0-387-30107-0
isbn_softcover978-0-387-20330-0
isbn_ebook978-0-387-30107-5
copyrightSpringer-Verlag New York 2006
The information of publication is updating

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Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoarction. The primary outcome was total mortality. The trial ended nine months ahead of schedule because of clear benefit from propranolol. The independent monitoring committee considered several newly developed statistical approaches in recommending early stopping, as well as other factors, includin
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Early Termination of the Stroke Prevention in Atrial Fibrillation I Trial: Protecting Participant Innts with nonvalvular atrial fibrillation. Participants were categorized as either warfarin-eligible or warfarin-ineligible based on contraindications to or refusal of anticoagulation, and interim efficacy monitoring examined treatment effects separately by warfarin eligibility. The planned primary a
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Data Monitoring in the AIDS Clinical Trials Group Study #981: Conflicting Interim Results200 mg daily) with clotrimazole lozenges (10mg, five times daily) for prevention of invasive fungal infections in patients with advanced HIV disease. At the fourth DSMB review of the study in November 1992, the patients on fluconazole had a significantly lower risk of invasive, serious and superfici
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Challenges in Monitoring the Breast Cancer Prevention Trialcal Breast and Bowel Project (NSABP), a National Cancer Institute (NCI)-funded cancer cooperative group. The primary hypothesis tested was whether tamoxifen, a drug that is beneficial for treatment of breast cancer, was effective in preventing the occurrence of cancer in women at increased risk. The
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Stopping the Randomized Aldactone Evaluation Study Early for Efficacy of daily spironolactone to standard therapy would reduce the risk of all-cause mortality in patients with severe heart failure as a result of systolic left ventricular dysfunction. The Data Safety Monitoring Board (DSMB) for RALES reviewed data on safety and efficacy throughout the trial using pre-
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Data Monitoring in the Heart Outcomes Prevention Evaluation and the Clopidogrel in Unstable Angina tin the data, but also to avoid the loss of important treatment information concerning secondary outcomes, key subgroups, and patient safety data. For the Heart Outcomes Prevention Evaluation (HOPE) and Clopidogrel in Unstable Angina to Prevent Recurrent Ischemic Events (CURE) trials, their Data and
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