- Statistics Applied to Clinical Trials | SpringerLink?
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- Statistics Applied to Clinical Trials!
Abstract Several types of endpoints may be used to assess the efficacy of anticancer therapy. Historically, tumor shrinkage has been considered an important indicator of chemotherapy activity, and in many diseases there is an association between objective responses and treatment benefit at the patient level. As a result, objective responses have been used as primary or secondary endpoints in cancer clinical trials, and different criteria have been proposed over the years in order to standardize response assessment.
Although response rates have not been confirmed as good surrogates for overall survival in various disease settings, response assessment is an essential component in the development of cytotoxic agents as well as a very useful indicator of treatment efficacy in the clinic. On the other hand, problems arise when response rates are used to assess the benefit of some targeted agents and immune checkpoint inhibitors.
ISBN 13: 9781402005695
This talk will provide an overview of the goals, methods and limitations of response assessment in oncology. Biography Everardo Saad is a medical oncologist with a special interest in clinical-trial methodology. After several years of clinical practice, he shifted his career toward consultancy in clinical research.
He currently serves as associate editor of the journal Trials, and has published more extensively in the area of efficacy endpoints in oncology. Abstract Assessment of tumour burden is an integral part of clinical trial methodology in oncology.
The RECIST criteria, implemented in and updated in , provide a tool for uniform assessment of tumour burden in multicentre clinical trials across multiple solid tumour types. I will review some alternative response assessment criteria together with the level of evidence on which they are based.
In that same year she started her career as a statistician in the Center for Statistics Censtat at the Hasselt University. An alternative to a model based analysis is to have analyses guided by the design of the trial.
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- 1.1 - What is the role of statistics in clinical research?.
Our development of design based methods allows the incorporation of centers as well as other features of the trial design. The methods make use of conditioning on the ancillary statistics in the sample space generated by the randomization process. We have investigated the power of the methods and have found that, in the presence of center variation, there is a significant increase in power.
The methods have been extended to group sequential trials with similar increases in power. Source Ann. Zentralblatt MATH identifier Keywords Multi-center trials randomization permuted blocks design design based analyses.
- What is the role of statistics in clinical research? | STAT
Zheng, Lu; Zelen, Marvin. Multi-center clinical trials: Randomization and ancillary statistics. Abstract Article info and citation First page References Abstract The purpose of this paper is to investigate and develop methods for analysis of multi-center randomized clinical trials which only rely on the randomization process as a basis of inference.
Article information Source Ann. Export citation. Export Cancel. References Andersen, P.