Hydroxyethyl Starch on Kidney and Haemostatic Function in Cardiac Surgical Patients: Is A Non-Inferiority Study Design Appropriate for This Setting?
In light of the existing concerns on HES use, this study leaves several unanswered questions: how should patients be informed when they are asked to participate in a clinical trial that may randomise them to receive HES? How can a prestigious research group consider it appropriate to adopt a ’non‐inferiority’ study design to evaluate the safety profile of a controversial drug such as HES, when any proven beneficial effects (if there are any) remain unanswered?
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