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[How Should We Design, Conduct, Evaluate, and Apply Clinical Study in a Clinical Setting]
Mototsugu Shimokawa1, Toshinobu Hayashi
1Dept. of Biostatistics, Yamaguchi University Graduate School of Medicine.
Abstract:
The palliative care, methodologies, and evaluation methods of clinical study for chemotherapy-induced nausea and vomiting( CINV)are not defined well. In addition, it is important to consider that individualized antiemetic therapy should be treated according to each patient's risk factors as well as the emetogenicity of chemotherapy regimens. While the CTCAE is being widely used by medical staff in clinical practice for the evaluation of CINV, the patient-reported outcome(PRO)is also considered as an important method of assessment. In this article, we describe matters to consider during the process of designing, evaluating, and applying in a clinical setting for CINV study. Based on "Supportive care and policy of palliative care CINV" which is going to be published, we expect that clinical study designs would be optimized to accelerate the establishment of evidence by utilizing not only randomized controlled trial(RCT), but also real world data(RWD).
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