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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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.
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
Advisory committee review of safety issues with the PI3K inhibitor class of drugs for hematologic malignancies served as a platform for the Oncology Center of Excellence’s Project Optimus initiative, which emphasizes an earlier and more thorough assessment of different doses, including through randomized trials.