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. Author manuscript; available in PMC: 2016 Mar 1.
Published in final edited form as: Adv Drug Deliv Rev. 2014 Dec 7;0:192–196. doi: 10.1016/j.addr.2014.12.001

Figure 1.

Figure 1

Diagram of the evolving clinical trials process and other mechanisms of therapy translation to the bedside. The traditional, multi-phasic FDA clinical trials process is shown in black with a black arrow from bench to bedside. Evolving FDA mechanisms for accelerating the clinical trial process are shown in orange. Compassionate Use (also known as “Expanded Access”) and Right To Try (RTT) are shown in green with a loop reflecting the bypassing of Phase 2 and Phase 3. It is notable that the requirements for Compasionate Use are evolving and there are diverse stakeholder views. The precise pre-requisites (e.g. Phase 1 versus Phase 2 data) obtainable from FDA guidance are not completely clear and may vary on a case-by-case basis. The common stem cell clinic approach of entirely avoiding the clinical trials approval process is shown in red. Note that for some non-more than minimally manipulated stem cell products used in a homologous manner, direct use by stem cell clinics or other physicians may be appropriate with only a relatively minor role for the FDA.