By Dr. Reem Yunis
In prior posts, we noted that COAs play a significant role in regulatory submissions. In this post we will look closely into the clinician reported outcomes (ClinROs) type.
Medicine is both science and art, and as such it is subjective in nature, as those who practice it have their own perception of the disease and how their patients are responding to the prescribed treatment. Because approvals of regulatory submissions take into consideration patient health outcomes in regard to effectiveness and safety of the new product (or repurposed product), clinical outcome assessments determined by clinicians must follow the scientific method more than the art! Clinical assessments utilizing ClinROs must be carried out by a healthcare professional with specific training in the area in which the rating/assessment is being determined to establish confidence and to ensure reliability in the rating, especially when utilized to determine the benefits and risks of a medical intervention.