CADTH is expanding its Scientific Advice program to include applications for advice on real-world evidence (RWE) generation plans after protocols for pivotal trials have been finalized. This is an opportunity for pharmaceutical companies to enhance their engagement with CADTH regarding RWE.
The expanded program will run for a 1-year learning period and requests will be considered until March 31, 2023. Any request must include questions related to RWE generation plans; questions on economic modelling may also be included. Priority will be given to rare diseases; however, all requests will be considered based on availability of meeting dates. Advice will continue to be offered from CADTH alone or in parallel with Health Canada or the National Institute for Health and Care Excellence (NICE). The established scientific advice processes will be followed.
Early CADTH Scientific Advice services prior to finalization of pivotal trial protocols still plays an important role and continues to be offered. Questions related to RWE planning are also accepted at this earlier stage.
To discuss potential applications for CADTH Scientific Advice, please contact firstname.lastname@example.org.