FDA issued a final guidance, “Conducting Clinical Trials with Decentralized Elements,” providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials.
With the recent FDA approval of daratumumab for high-risk smoldering multiple myeloma, the moment is ripe to revisit the evolution of our understanding of smoldering multiple myeloma. This development not only underscores the growing recognition of early intervention but also invites a broader reflection on the biological insights and therapeutic strategies that have shaped—and continue to shape—this transitional disease state.
