Assessing Haemostatic Efficacy In VWF/FVIII Replacement Therapy Trials Utilizing Subjective Vs. Objective Criteria – a Way to Improve Comparability and Accuracy of Clinical Outcome.
Abstract:1424
Objective:
The assessment of the clinical efficacy during the conduct of a clinical trial is critical to the potential acceptance of that product to be a viable therapeutic option. This is especially true in the conduct of clinical trials involving rare bleeding disorders such as VWD, where there is predictably small patient enrollment and limited use of a control group. A 4-point Likert hemostatic efficacy scale with mostly subjective general criteria (… Show more
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