Design Issues in Randomized Phase II/III 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...
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In combination with randomization, blinding or masking is an important factor in randomized controlled trials (RCTs), particularly in trials that assess therapeutic effects. Here an attempt is made to explain blindness and why it is important. In clinical trials, blinding is defined as the condition imposed on a study in which study participants, health care providers and assessors collecting o...
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Randomized clinical trials of early nutritional interventions in infants are necessary to establish safety and efficacy of supplementation of infant formulas with LCPUFAS for term and preterm infants. Such trials pose significant methodologic difficulties when applied to infants because of the rapidly changing development of the infant's central nervous system and its interdependence with multi...
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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...
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The first part of my dissertation focuses on post-randomization modification of intent-to-treat effects. For example, in the field of behavioral science, investigations involve the estimation of the effects of behavioral interventions on final outcomes for individuals stratified by post-randomization moderators measured during the early stages of the intervention (e.g., landmark analyses in can...
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ژورنال
عنوان ژورنال: Journal of Clinical Oncology
سال: 2012
ISSN: 0732-183X,1527-7755
DOI: 10.1200/jco.2011.38.5732