Bayesian clinical trial design using historical data that inform the treatment effect
نویسندگان
چکیده
منابع مشابه
Short-interval observational data to inform clinical trial design in Huntington's disease.
OBJECTIVES To evaluate candidate outcomes for disease-modifying trials in Huntington's disease (HD) over 6-month, 9-month and 15-month intervals, across multiple domains. To present guidelines on rapid efficacy readouts for disease-modifying trials. METHODS 40 controls and 61 patients with HD, recruited from four EU sites, underwent 3 T MRI and standard clinical and cognitive assessments at b...
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Obstacles sometimes limit enrollment in randomized clinical trials of an experimental product versus an active control, making it desirable to augment the randomized control group with historical control groups. However, bias between control groups with respect to the mean outcome could lead to spurious conclusions. Methods are necessary that allow for the combination of control groups while co...
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BACKGROUND AND PURPOSE Clinical research into the treatment of acute stroke is complicated, is costly, and has often been unsuccessful. Developments in imaging technology based on computed tomography and magnetic resonance imaging scans offer opportunities for screening experimental therapies during phase II testing so as to deliver only the most promising interventions to phase III. We discuss...
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Clinical trials are expensive. Understanding where a trial is needed and what questions to address is therefore important. We ask if pilot work using observational healthcare data can be used to inform a trial. Symptoms of significant psychological distress are common in cancer patients but are often left untreated. It is unknown to what extent such distress symptoms persist over time and requi...
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ژورنال
عنوان ژورنال: Biostatistics
سال: 2018
ISSN: 1465-4644,1468-4357
DOI: 10.1093/biostatistics/kxy009