Figure 2.

Frameworks and goals for proof-of-concept clinical trials of interventions that target fundamental aging processes. These interventions are hypothesized to affect multiple age-related diseases and conditions: the “geroscience hypothesis.” Three frameworks are presented for the design of clinical trials to test these interventions for effects on outcomes related to age-related diseases, geriatric syndromes, and resiliency. Proof-of-concept clinical trials would test the geroscience hypothesis, but also provide evidence of efficacy in the outcome being targeted, as well as data and samples for further research. Ultimately, proof-of-concept trials will help justify and in the design of larger clinical trials and support new regulatory indications for interventions that target fundamental aging processes.