Coping with missing data in phase III pivotal registration trials: Tolvaptan in subjects with kidney disease, a case study
In conclusion, straightforward and transparent analyses directly taking into account missing data convincingly support the robustness of the preplanned analyses on the primary and secondary endpoints. Tolvaptan was confirmed to be effective in slowing total kidney volume growth, which is considered an efficacy endpoint by EMA, and in lessening the decline in renal function in patients with autosomal dominant polycystic kidney disease.
Source: Pharmaceutical Statistics - Category: Statistics Authors: John Ouyang, Kevin J. Carroll, Gary Koch, Junfang Li Tags: MAIN PAPER Source Type: research
More News: European Medicines Agency (EMA) | Eyes | Polycystic Kidney Disease | Statistics | Study | Urology & Nephrology