Compliance Concerns Slow Industry Uptake Of Cancer Patient-Reported Outcomes Tool
Potential need to reconcile physician-reported adverse event data with patient reports of symptom side effects is a concern for Merck; AstraZeneca’s experience using the PRO-CTCAE instrument in cancer trials shows the importance of educating study sites about the value of patient experience data.
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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.
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.
US FDA staff suggest that oncology and rheumatology instruments could be leveraged or supplemented to make them fit for purpose in assessing toxicity of immunosuppressive regimens in transplant recipients.