Randomized Phase II Clinical Trials
نویسندگان
چکیده
منابع مشابه
Design issues of randomized phase II trials and a proposal for phase II screening trials.
Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II trials have been key components in the prioritization process. There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm to provide greater ass...
متن کاملModeling Heterogeneity in Phase II Clinical Trials
Problem statement: The common assumption in non-randomized Phase II clinical trials is a homogeneous population with homogeneous response. This assumption is at odds with many trials today; a heterogeneous response due to the existence of subgroups. Approach: In order to examine the effects of heterogeneity on the trial outcome, a systematic platform is developed to quantify the range and class...
متن کاملRandomized Phase II Trials: a Bayesian Two-Stage Design
Single-arm two-stage designs are commonly used in phase II of clinical trials. However, the use of randomization in phase II trials is currently increasing. We propose a randomized version of a Bayesian two-stage design due to Tan and Machin [2]. The idea is to select the two-stage sample sizes by ensuring a large posterior probability that the true response rate of the experimental treatment e...
متن کاملNEW DESIGNS FOR PHASE II CLINICAL TRIALS Short title: New Designs for Phase II Clinical Trials Scientific Section Heading: Clinical Observations, Interventions, and Therapeutic Trials
Conventional phase II clinical trials are typically single-arm experiments, with outcome characterized by one binary “response” variable. Clinical investigators are poorly served by such conventional methodology. We contend that phase II trials are inherently comparative, with the results of the comparison determining whether to conduct a subsequent phase III trial. When different treatments ar...
متن کاملAccounting for patient heterogeneity in phase II clinical trials.
Phase II clinical trials typically are single-arm studies conducted to decide whether an experimental treatment is sufficiently promising, relative to standard treatment, to warrant further investigation. Many methods exist for conducting phase II trials under the assumption that patients are homogeneous. In the presence of patient heterogeneity, however, these designs are likely to draw incorr...
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ژورنال
عنوان ژورنال: Journal of Biopharmaceutical Statistics
سال: 2014
ISSN: 1054-3406,1520-5711
DOI: 10.1080/10543406.2014.901343