Early Evidence assessment that is based on a clinical guideline / HTA review of relevant proxy assets; includes identification of evidence gaps as well as analysis of planned trial design and development of study / evidence generation proposals; results will be summarized in an Early Evidence Generation Plan; includes 12 month EVIGATOR license.
Included:
Kick-off meeting
Bi-weekly virtual status calls
Clinical guideline review of the target disease in France, Germany, US and the UK
HTA decision review in France, Germany, the UK (may also include proxy diseases, if applicable; only decisions that are openly communicated included; may also cover relevant ICER decisions) covering 2-3 decisions per country
Analysis of planned clinical trial design
20-30 pages summary presentation summarizing the previous activities as well as our recommendations around evidence needs and evidence gaps; 1-2 virtual workshops around these recommendations
Assessment of available databases in EU-4 plus UK and US (based on publicly available information)
Development of an EGP down to the level of 1-page study synopsis per recommended study; one virtual workshop to discuss the EGP; documentation of EGP in EVIGATOR software, a 12 months license to EVIGATOR is included in the budget
