By Stephen L. George, Xiaofei Wang, Herbert Pang
Cancer scientific Trials: present and arguable matters in layout and Analysis offers statisticians with an figuring out of the serious demanding situations presently encountered in oncology trials. recognized statisticians from educational associations, regulatory and govt enterprises (such because the U.S. FDA and nationwide melanoma Institute), and the pharmaceutical proportion their wide reviews in melanoma medical trials and current examples taken from genuine trials.
The publication covers subject matters which are usually puzzling and occasionally debatable in melanoma medical trials. lots of the concerns addressed also are vital for scientific trials in different settings. After discussing basic subject matters, the publication specializes in elements of early and overdue part medical trials. It additionally explores customized medication, together with biomarker-based scientific trials, adaptive scientific trial designs, and dynamic remedy regimes.
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Additional resources for Cancer clinical trials: current and controversial issues in design and analysis
With the growing interest in the research community, the Patient-Centered Outcomes Research Institute (PCORI), a nonprofit nongovernmental organization, was established in 2010 to facilitate the advancement of patient focused comparative effectiveness research. In November 2013, the Methodology Committee of the PCORI released their Methodology Report to provide guidance for the achievement of that goal. 2 Types of PRO for Treatment Comparisons PRO has become more commonly used as a primary endpoint or remained as a key secondary endpoint in cancer trials.
Overall survival (OS) is the gold standard endpoint for evaluating the effect of new therapy in cancer. However, compared to progression-free survival (PFS), it requires large number of patients and long follow-up to accumulate sufficient number of events to achieve adequate statistical power. There is a great need in cancer research to find and validate surrogate endpoints, that are able to accurately capture the treatment effect, that are cheap to measure, and that achieve the required number of events earlier than OS.
For example, Phase I and II clinical trials are relatively small trials designed to determine an appropriate dose or schedule for an agent or to detect some minimal activity and, with rare exceptions, OS would in general not be an appropriate primary endpoint for such trials. Even for phase III cancer trials, in which OS is nearly always an important endpoint, there are difficulties. Most cancer therapies are given over a prolonged period of time, thereby increasing the probability of non-adherence to the assigned treatment.
Cancer clinical trials: current and controversial issues in design and analysis by Stephen L. George, Xiaofei Wang, Herbert Pang