Trends in the use of outcome parameters for Respiratory Drug Research

Author(s): Robert Lins

Substantial success has been realized within the treatment respiratory diseases due to more insight within the mechanisms of disease like inflammatory pathways and new targets for treating these diseases. However, there is a transparent discrepancy between the outcome parameters, currently utilized in clinical studies, and clinical outcome and survival. So, there is an unmet need for additional more sensitive outcome parameters that might assist in understanding the mode of action and subsequent pharmacodynamics effects. The ever-rising costs and rate of attrition of developing new respiratory drugs, makes it mandatory to extend the performance of clinical trials by using these methods and by more efficient study designs. Patient-reported outcome (PRO) measures that quantify disease impact became important measures of outcome in COPD research and treatment. The development of COPD may affect several aspects of a patient's health. These consequences of illness are often considered a process of illness progression, which normally starts at the event of physiological or biological abnormalities, leading to symptoms and physical limitations that are noticed and reported by the patients. Eventually, patients will need to face their inability to take part in their usual activities, which can influence their perception of their health and ultimately their general well-being.