Measuring clinical benefit: use of patient-reported outcomes (PRO) in primary brain tumor clinical trials.

Primary brain tumors and their treatment are associated with a significant impact on function and quality of life (QOL). Patient-reported outcomes (PROs) are measures that allow report of the impact directly from the patient. Instruments to measure both QOL and symptom burden have been developed for use in the primary brain tumor patient population. Use of these instruments coupled with tumor response assessment and other objective measures will allow for evaluation of the net clinical benefit for the patient.