This insight brief notes that Clinician‑Reported Outcomes (ClinROs) are widely used as endpoints in CNS trials but are challenged to meet new FDA patient‑focused guidelines. The growing burden of CNS disorders and shift toward patient‑centric research require fit‑for‑purpose assessments. Using legacy ClinROs outside their original context can miss relevant symptoms (e.g., post‑partum depression or early Alzheimer’s). Many scales assume slow symptom change, yet new treatments may have rapid effects. Signal detection is further compromised by rater variability and inconsistent administration across sites. The brief advises rigorous evaluation of existing instruments, patient involvement in instrument design and standardized training to improve reliability and sensitivity.

Join for free to read