Impact of random variation in albuminuria and estimated glomerular filtration rate on patient enrolment and duration of clinical trials in nephrology.
Simke W WaijerMichele ProvenzanoSkander MulderPeter RossingFrederik PerssonVlado PerkovicHiddo J Lambers HeerspinkPublished in: Diabetes, obesity & metabolism (2022)
More flexible albuminuria and eGFR-based inclusion criteria, in participants who met the inclusion criteria of a trial based on pre-screening values prior to the clinical trial, decreases screen failure rates and accelerated patient enrolment leading to more efficient trial conduct without impacting the overall trial duration.