FDA Oncology Office Looks To Get Better INFORMED Through Big Data
Under the Information Exchange and Data Transformation initiative, existing clinical trial datasets will be standardized and integrated with real-world sources in a new data environment.
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Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.
Agency would consider a site-agnostic indication for tumors with high mutation burden if results from the proposed pragmatic clinical practice study were positive.
Industry, patient advocates seek to use data collected outside traditional clinical trials to confirm benefit or broaden labeling, but FDA officials say large drug effects would be needed to overcome 'noise' from more loosely structured studies.