Diana Merino Vega, Senior Director of Cancer Biomarker Development at AstraZeneca, shared a post on LinkedIn:
“Fascinating discussions just wrapped up at the FDA- AACR workshop on approaches to novel oncology endpoint development, where key opinion leaders across advocacy organizations, academia, FDA and industry came together to advance our collective understanding and align on strategies that enable the generation of evidence needed for novel endpoints in oncology clinical trials.
We heard loud and clear that unmet need drives novel endpoint development and that a key to ensuring efficient pooled and meta-analyses is harmonization of endpoint definitions, thresholds and criteria across cancer types. Otherwise, collected patient data may not be as useful as possible.
There is a large role for patient advocates and advocacy organizations to provide their input and impact the alignment and agreement on these concepts – and from what I heard today, there is multidisciplinary willingness to participate in collaborations that will reduce time for novel endpoints development.
The science of endpoint development is evolving rapidly and we need to be prepared to move fast and be as flexible as possible… we owe this to patients!
As workshop co-chair Lillian Siu mentioned in her wrap up comments, we are standing at an inflection point and the dialogue is just getting started!”
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