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1 itional, protocol-prespecified secondary endpoint data, and statistical analysis plan-prespecified descriptive endpoints
2 using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed th
3 he context of negative findings for the primary outcome and statistical analysis plan, this lower incidence was not consi
4 s (405 studies [86.5%] vs 87 studies [65.9%]; P < .001) and statistical analysis plans (373 studies [79.7%] vs 73 studies
5 ing framework for study designs, sample size estimates, and statistical analysis plans for future pivotal trials of islet
6 that they planned to share data and make both protocols and statistical analysis plans available, raw data and code were
7 To ensure transparency, protocols and statistical analysis plans need to be published, and investig
9 tion drives experimental design, randomization schemes, and statistical analysis plans, while neglecting social context.
11 Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eig
13 is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and
14 This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, e
15 ethodology are that we did not have an a priori protocol or statistical analysis plan because the analysis was initially
16 arters of trials had full protocols (482 trials [82.0%]) or statistical analysis plans (446 trials [74.3%]) available, bu
20 Blinded intention-to-treat analysis based on a prespecified statistical analysis plan included all participants eligible
21 Analyses were conducted according to a prespecified statistical analysis plan, using multiple logistic regression
22 h trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpubli
23 types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT a
24 (sponsor, author, and analyst) and transparency (protocols, statistical analysis plans, and data and code availability).
30 ped after an unplanned interim analysis of cohort 1 and the statistical analysis plan for the primary endpoint was amende
34 y and will be reported when the timepoint, according to the statistical analysis plan, has been reached.
35 l trials should include a stacked probability plot in their statistical analysis plan as descriptive analysis.