Adaptive Trial Designs
نویسندگان
چکیده
منابع مشابه
HIV-1 vaccines and adaptive trial designs.
Developing a vaccine against the human immunodeficiency virus (HIV) poses an exceptional challenge. There are no documented cases of immune-mediated clearance of HIV from an infected individual, and no known correlates of immune protection. Although nonhuman primate models of lentivirus infection have provided valuable data about HIV pathogenesis, such models do not predict HIV vaccine efficacy...
متن کاملBiomarker informed adaptive clinical trial designs
In adaptive design clinical trials, an endpoint at the final analysis that takes a long time to observe is not feasible to be used for making decisions at the interim analysis. For example, overall survival (OS) in oncology trials usually cannot be used to make interim decisions. However, biomarkers correlated to the final clinical endpoint can be used. Hence, considerable interest has been dra...
متن کاملAdaptive trial designs: a review of barriers and opportunities
Adaptive designs allow planned modifications based on data accumulating within a study. The promise of greater flexibility and efficiency stimulates increasing interest in adaptive designs from clinical, academic, and regulatory parties. When adaptive designs are used properly, efficiencies can include a smaller sample size, a more efficient treatment development process, and an increased chanc...
متن کاملSMARTer discontinuation trial designs for developing an adaptive treatment strategy.
OBJECTIVE Developing evidenced-based practices for the management of childhood psychiatric disorders requires research studies that address how to treat children during both the acute phase of the disorder and beyond. Given the selection of a medication for acute treatment, discontinuation trials are used to evaluate the effects of treatment duration (e.g., time on medication) and/or maintenanc...
متن کاملBenefits, challenges and obstacles of adaptive clinical trial designs
In recent years, the use of adaptive design methods in pharmaceutical/clinical research and development has become popular due to its flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation. The flexibility and efficiency, however, increase the risk of operational biases with resulting decrease in the accuracy and reliability fo...
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ژورنال
عنوان ژورنال: Annual Review of Pharmacology and Toxicology
سال: 2012
ISSN: 0362-1642,1545-4304
DOI: 10.1146/annurev-pharmtox-010611-134504