US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data
Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.
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US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch
Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.
Pediatric Cancer Trials: US FDA Panel To Weigh Use Of Real-World Data, Patient-Reported Outcomes
Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.
Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals
Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.