Business case studies
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Holistic Data Analysis
Mid-size US biotech company, phase 3 oncology trial
Initial analysis using conventional statistics focused on the frequency of AE as the single endpoint. One2Treat complemented the analysis of the data by capturing the combined effect of the drug on the frequency, severity, duration, and time to onset of the AE. The One2Treat approach led to increased statistical and clinical significance, offering the FDA a compelling case for the substantial benefits of the drug candidate.
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