Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims
Executive Summary
New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.
You may also be interested in...
Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says
In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.
Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says
Heterogeneity in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.
Patient-Reported Outcomes In Pediatric Cancer Trials Endorsed By US FDA Advisory Committee
Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.