Phase II Clinical Trials: Issues and Practices
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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INTRODUCTION There are 2 broad classes of anticancer drugs that require different approaches to development. The classical cytotoxic agents have low therapeutic indices and therefore traditionally have different developmental strategies from non-oncology agents. The newer anticancer agents that target the signal transduction pathway and antiangiogenesis pathway have characteristics similar to n...
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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...
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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...
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The large number of negative phase III trials in oncology over the last several years has renewed interest in refining phase II oncology clinical trials to maximize the chances of success in phase III testing. More efficient phase II study designs will improve our ability to identify promising agents for testing while accurately identifying nonefficacious agents. Recognizing that new paradigms ...
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ژورنال
عنوان ژورنال: Biometrics & Biostatistics International Journal
سال: 2014
ISSN: 2378-315X
DOI: 10.15406/bbij.2014.01.00008