. Author manuscript; available in PMC: 2013 Aug 3.

Published in final edited form as: Arch Phys Med Rehabil. 2012 Jun 7;93(8 0):S101–S110. doi: 10.1016/j.apmr.2011.11.040

Table 1.

Phases of Translational Research

Stage of Rehabilitation Research Development	Correspondence to Pharmaceutical Phased Research Development	Translational Task and Obstacles
Idea inception	Phase 0⁹	Viewing unexpected observations/findings and negative results as opportunity to generate ideas rather than as trivia/research errors is critical to innovative idea generation.
Natural history and measurement	Contributes to phase I—the underlying recovery trajectory and object of treatment needs to be delineated in order to detect adverse effects and treatment effects	Relationship of treatment mechanism to object of treatment under study must be defined (treatment theory). Relationship of object of treatment and outcome measures must also be clear.
Proof of concept	Phase I, Phase II	Refinement of treatment theory may radically alter the idea under study. Paradigmatic rigidity (no useful stroke recovery can occur after 6mo) could block further development.
Evaluate efficacy	Phase III	Define experimental conditions so as to limit variability/ confounds while avoiding type II error and generating feasible protocols for the next study phase. New statistical analytic techniques (modeling) may be highly useful.
Evaluate effectiveness	Phase IV	Requires rigorous implementation of enablement theory, even when treatment theory has guided process up to this point.