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Sample sizes in dosage investigational clinical trials a systematic evaluation文档
Drug Design, Development and Therapy Dovepress
open access to scientific and medical research
Open Access Full Text Article R e v i e w
Sample sizes in dosage investigational clinical
trials: a systematic evaluation
Ji-Han Huang 1,* Abstract: The main purpose of investigational phase II clinical trials is to explore indications and
2, effective doses. However, as yet, there is no clear rule and no related published literature about
Qian-Min Su *
Juan Yang 1 the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched
Ying-Hua Lv 1 for clinical trials in the ClinicalT registry using the keywords “dose-finding” or “dose–re-
Ying-Chun He 1 sponse” and “Phase II”. The time span of the search was September 20, 1999, to December 31, 2013.
Jun-Chao Chen 1 A total of 2103 clinical trials were finally included in our review. Regarding sample sizes, 1,156 clin-
1 ical trials had 40 participants in each group, accounting for 55.0% of the studies reviewed, and
Ling Xu
1 only 17.2% of the studies reviewed had 100 patient cases in a single group. Sample sizes used
Kun wang
in parallel study designs tended to be larger than those of crossover designs (median sample size
Qing-Shan Zheng 1
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