Precision Medicine Evidence Gaps Could Be Filled With Real-World Data, Central Repository
While not recommending changes in US FDA approval standards, Harvard researchers urge more disclosure about what is known and not yet known about targeted medicines. A central repository of data should be created, they suggest, allowing drug makers, test makers and pathology labs to share real-world data after approval. The journal article considers existing data for Novartis and Roche's approved BRAF inhibitor therapies to illustrate gaps in understanding about precision medicines.
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