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W., Yaghmai, A
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doi: 10.1038/gt.2010.58
The FDA's accelerated approval pathway and the EMA's adaptive pathways program have further intensified Phase II DCT adoption by incentivizing sponsors to generate early efficacy signals from broader, more representative patient populations an objective directly facilitated by hybrid and decentralized enrollment models that extend geographic reach without proportional site network expansion
This is an example of how protocols evolve based on the patient's changing needs over time
