Last Updated : April 25, 2023
During a 1-year learning period, CADTH expanded its Scientific Advice program to include advice on real-world evidence (RWE), allowing applications after lockdown of protocols for pivotal trials. Based on the positive experience and considerable interest from industry, CADTH is formalizing this offering to enhance early engagement opportunities for pharmaceutical companies regarding RWE. Key benefits of early engagement with CADTH on RWE plans include: a better understanding of the potential gaps that could be addressed by RWE, considerations for identifying relevant data sources and clinically important outcomes, methodological considerations, and how RWE may be considered within the CADTH Reimbursement Review process.
Scientific Advice on RWE is now a standard offering and can be requested “post–pivotal trial” but will currently be restricted to applications submitted in the preregulatory phase. Requests must include questions related to RWE generation plans; questions related to the ongoing pivotal trial(s) and economic modelling may also be included. Priority will be given to rare diseases or pediatric populations; 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 play an important role and continue 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.