Precision Medicine Evidence Gaps Could Be Filled With Real-World Data, Central Repository
Executive Summary
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.