Conditional Approvals for Autologous Stem Cell-Based Interventions: Conflicting norms and institutional legitimacy .

摘要: Demands from patients, health-care professionals, and industry to streamline the market approval process for promising new therapies has prompted introduction of programs that can provide more rapid access stem cell-based products before evidence safety efficacy been demonstrated in clinical trials. These may be approved marketing under "conditional authorizations," while uncertainty around is reduced through collection data observational trials or registries. The rationale conditional assumes patients with unmet medical needs will benefit novel cell therapies. It also gathered actual contexts inherently better at reducing than conventional trial methods demonstrating efficacy. assumptions overly optimistic do not account broader societal burdens prematurely releasing high-cost uncertain risks benefits on markets. This essay focuses autologous somatic argues these conflict with, potentially undermine, normative commitments regulatory agencies charged promoting population health protecting vulnerable groups harm exploitation. concludes suggestions how designed accelerate helpful but experimental interventions could reconfigured equitable.