Although all patients were treated with sorafenib according to a prospectively designed regimen, the study was not designed as a prospective phase II trial.
The prospective phase identified 17 women required HDU according to physiology scoring.
This can be best achieved through thoughtful design of prospective phase I dose-escalation studies.
Briefly, a prospective phase 1a, single blind, randomized, placebo controlled, dose-escalating study was conducted in 46 healthy malaria-naïve adult volunteers.
This prospective phase I, single blind, randomized, placebo controlled, dose-escalating study was conducted in 46 healthy adult volunteers at the Clinical Research Center, University Hospital, Basel, Switzerland.
This was a prospective phase II trial.
Two hundred participants were enrolled during this prospective phase.
The GEMA project, is a prospective phase IV clinical trial.
Only two of the above studies were prospective phase II.
A multicentre, non-blinded prospective, phase III RCT.
The study is designed as a prospective phase II trial.
