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The first (i) being independent replication of clinical trial data analysis to verify the regulatory authority's positions and challenge them where appropriate, and the second (ii) related to secondary analyses enabling the wider scientific community to make use of detailed and high-quality clinical trial data to develop new knowledge in the interest of public health.
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For clinical trial data, meta-analysis of summary-level efficacy and safety data from multiple trials provides a quantitative framework for comparative efficacy and safety assessment.
A common method of analyzing clinical trial data is to use analysis of variance or analysis of covariance (ANOVA or ANCOVA) with missing data imputed by the last observation carried forward approach (LOCF_ANCOVA).
We begin with relatively established approaches such as formal subgroup analysis of clinical trial data, and heterogeneity in meta-analysis of trials.
We anticipate that cleaner, larger sets of clinical trial data would improve our analysis.
However, to directly investigate the difference between placebo- and drug-associated side effects, clinical trial data from the aggregate analysis of ClinicalTrials.gov (AACT) was used.
In addition, only two weeks of clinical trial data were available for analysis, precluding the evaluation of responsiveness to change in clinical status.
A follow-up analysis of clinical trial data found clinically meaningful weight loss (≥5 % of body weight) achieved during short-term mifepristone use was sustained in approximately 80%% of patients with CS who were treated with mifepristone for up to 3.5 years.
The study is the first compilation of clinical trial data — called a meta-analysis — to show a statistically significant increase in the risk of death from the drugs, said Dr. Charles L. Bennett, a professor at Northwestern University and its lead author.
This additional length of stay was determined on the basis of post hoc analysis of recent clinical trial data [ 16, 21, 22] wherein bivariate analysis was conducted to compare length of stay in patients with or without moderate or severe adverse events and in patients with first-line treatment success versus failure.
When a higher HBV infection rate (based on clinical trial data) was substituted in the analysis, the cost effectiveness of a predialysis vaccination strategy improved to $856 per case prevented.
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