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One of the treatments under study is gene therapy to produce a protein called vegF, for vascular endothelial growth factor.
As the National Cancer Center points out in its excellent booklet, "Taking Part in Clinical Trials: What Cancer Patients Need to Know": "New treatments under study are not always better than, or even as good as, standard care.
In a sequential clinical trial, the accumulating data are subjected to a series of interim analyses, each of which involves a comparison of the treatments under study in respect of the primary efficacy criterion.
The STEPP (Subpopulation Treatment Effect Pattern Plots) method, by investigating the patterns of treatment effects within randomized clinical trials or datasets from meta-analyses, will help to identify features that predict responsiveness to the treatments under study without the pitfalls of selective retrospective subset analysis.
Many of the treatments under study are biologics, which are costly to produce in mass quantities.
Secondary outcomes were adverse effects due to the treatments under study.
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Last month the government halted a major study of hormone replacement therapy in healthy women, saying the treatment under study seemed to do more harm than good.
The purpose of a phase I trial in cancer is to determine the level (dose) of the treatment under study that has an acceptable level of adverse effects.
In principle, reference genes should be independent of any biological response to the treatment under study e.g. drought stress in our case.
Clinical trials of experimental treatments typically include purely research procedures, such as blood draws, imaging scans, or biopsies, that are performed to collect data regarding the treatment under study.
This requirement would be violated if subjects seek treatment because of the availability of the treatment under study.
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