Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions.

CONCLUSION: Collection of patient-reported outcome data in anti-programmed death receptor-1/programmed death-ligand-1 inhibitor trials were variable and did not consistently assess important symptomatic adverse events. Use of a patient-reported outcome instrument with well-defined functional scales supplemented by item libraries to incorporate relevant symptomatic adverse events may allow for improved understanding of the patient experience while receiving therapy. These data, along with other clinical data such as hospitalizations and supportive care medication use can help inform the benefit-risk assessment for regulatory purposes.
PMID: 30880446 [PubMed - as supplied by publisher]

Source: Clinical Trials - March 17, 2019 Category: Research Authors: King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG Tags: Clin Trials Source Type: research