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.
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US FDA Cancer Drug Dosage Optimization Guidance Will Increase Exposure To Ineffective Agents, NCI Says
Draft recommendations would lead to enrolling additional patients on multiple dose levels to assess activity before clinical effectiveness has been established, National Cancer Institute says; industry cites need for flexibility in recommending randomized studies of multiple dosages and questions utility of PRO data in early dose finding studies.
No Excuses: US FDA Wants Early, Thorough Dosage Optimization For Cancer Drugs
Breakthrough therapy designation is not a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus. Guidelines also emphasize randomized comparisons of multiple dosages and exploration of tolerability issues.
Patient-Reported Outcomes: Open-Label Trials Can Be Designed To Minimize Bias, US FDA Says
With the expectation for increasing amounts of patient experience data comes the need for the FDA and sponsors to consider, and account for, the degree to which open-label bias influences oncology trial PROs; agency staff suggest trial design elements and analytic approaches for dealing with bias at a meeting on cancer clinical outcomes assessments.