Wednesday, 6 May 2015

TRLs in the health sector

In Societal Challenges and Industrial Leadership, proposers are asked to position their project idea on the spectrum from idea to application or from lab to market, referring to TRLs (Technology Readiness Levels) where relevant. Some H2020 Workprogrammes make extensive use of TRLs in describing topics for proposals. But this is not the case with “Health, demographic change and wellbeing” where the EC says TRLs are not commonly used.
TRLs for pharmaceutical drugs
Maintain scientific technical watch
Research ideas & protocols are developed
Hypothesis testing & initial PoC demonstrated in limited number of in vitro & in vivo models
PoC & safety of candidate drug formulation is demonstrated in a defined laboratory or animal model
Pre-clinical studies, including GLP animal safety & toxicity, sufficient to support IND application
Phase 1 clinical trials support proceeding to phase 2 clinical trials. IND application submitted & approved by FDA
Phase 2 clinical trial complete. Phase 3 plan approved
Phase 3 completed. New drug application approved
Post marketing studies & surveillance
However, the US Army Medical Department does use TRLs for pharmaceutical drugs (see box). There are equivalent lists for bio-pharmaceuticals and vaccines, medical devices, and medical informatics. NATO uses similar descriptions. Interestingly, TRL levels 5 to 9 seem to correspond to the widely used definitions of phases 0 to 4 of clinical trials. So why not use TRLs in “Health”?

Singleimage - H2020 Training Workshops and Advice