Tanja Obradovic: Strategy of clinical development in oncology requires global considerations
Tanja Obradovic shared the following on LinkedIn:
“Strategy of clinical development in oncology always encompasses assessment of global filing with the US as a prominent country to consider, and no matter how parsed in business terms by individual sponsor or multiple partners, certain factors are critical.
The FDA just issued guidance that calls for multi-regional clinical trials to include US patients or at least accurately reflect them in study populations, and to have control arm treatments that are in line with US practice.
Recent examples of sintilimab and ivonescimab where China-only positive results in NSCLC raised questions on applicability to US population leading to need for global studies showcase potential issues. It is apparent that consideration of regional expansions or at least sufficient regional diversity in the late stage development is needed to be considered for promising assets early.
The draft guidance is entitled ‘Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs.’ Interested parties have 60 days to comment.”
Source: Tanja Obradovic/LinkedIn
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Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.
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