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R&D – engineering phase, phantom studies,
dosimetry in anthropomorphic phantoms
Clinical implementation, QA, process and
dosimetry measures, define use of technology
Systematic application in an expanded cohort of
consecutive pts, toxicity and efficacy endpoints
Bio-effect modeling to estimate clinical relevance
of quality improvement WITH 95% CI
Controlled clinical trial – randomized if possible
or opt-in on institutional basis, toxicity & efficacy
Post-marketing recording of outcomes,
generalizability of results when rolled out in the
community
Pre-clinical
Phase 0
Phase I/II
Phase IIIR
or
Phase IIINR
Phase IV
INCREASING EVIDENCE
Building evidence for RT
Courtesy of S. Bentzen
4D