Adaptive designs for comparative effectiveness research trials
نویسندگان
چکیده
منابع مشابه
Innovative designs of point-of-care comparative effectiveness trials.
One of the provisions of the health care reform legislation in 2010 was for funding pragmatic clinical trials or large observational studies for comparing the effectiveness of different approved medical treatments, involving broadly representative patient populations. After reviewing pragmatic clinical trials and the issues and challenges that have made them just a small fraction of comparative...
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BACKGROUND Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. PURPOSE Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a 'proof of concept' to stimulate investment in Bayesian adaptive designs for future CER tri...
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We develop a general class of response-adaptive Bayesian designs using hierarchical models, and provide open source software to implement them. Our work is motivated by recent master protocols in oncology, where several treatments are investigated simultaneously in one or multiple disease types, and treatment efficacy is expected to vary across biomarker-defined subpopulations. Adaptive trials ...
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The role of Phase II trials in oncology drug development Traditionally, Phase II in oncology drug development acts as a screening tool by identifying treatments with sufficient activity that warrant further investigation in large and costly Phase III studies. However, Phase II has also another more prominent role in cancer research as there is a significant number of drugs that were approved ba...
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ژورنال
عنوان ژورنال: Clinical Research and Regulatory Affairs
سال: 2014
ISSN: 1060-1333,1532-2521
DOI: 10.3109/10601333.2014.977490