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.
You may also be interested in...
US FDA’s Inner Circle Takes Shape: Shah Seen As Potential Successor To Abernethy
Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.
FDA, PD-1 Inhibitor Sponsors Discussing Real-World Study
Agency would consider a site-agnostic indication for tumors with high mutation burden if results from the proposed pragmatic clinical practice study were positive.
Real-World Evidence May Find A Home On Breakthrough Pathway
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.