Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims
New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.
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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.
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.
Whether US FDA may need to create a special labeling section for patient experience data is a ‘huge question that’s going to require a lot of discussion,’ Oncology Center of Excellence’s Kluetz says; agency is currently exploring non-labeling alternatives to communicating PRO data.