Regulatory uncertainty has some pharma industry sponsors wary about integrating a new patient-reported outcomes (PRO) instrument in their cancer trials.
At a US FDA/Critical Path Institute workshop April 25, a Merck & Co. Inc
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.
