CADTH officially advising on real-world evidence use in early drug development plans

28 Apr 2023

Written by Joanne Walker

Decision science Health policy Health technology assessment News Real-world evidence

Through the CADTH Scientific Advice Program, pharmaceutical companies can gain feedback from the agency on their plans to incorporate real-world evidence early – before development plans have been finalized.

CADTH (Canadian Agency for Drugs and Technologies in Health) has announced it can now formally advise companies on the use of real-world evidence (RWE) after protocols for pivotal trials have been finalized through its Scientific Advice Program. Via this program, which is voluntary, non-binding, confidential and subject to fees, companies can consult with the agency to gain feedback on their use of RWE in early drug development from a Canadian health technology assessment perspective. Based on the extensive feedback received, companies can adjust their development plans to help reduce uncertainty in this process and ensure more robust evidence is generated.

The formalization come after a 1-year ‘learning’ phase, where CADTH received favorable feedback and extensive interest from industry. By engaging with CADTH early on to discuss the use of RWE, industry can gain a better understanding into how RWE could address potential gaps, where relevant data sources and clinically important outcomes can be identified, how RWE studies can be carried out, and how RWE may be included within the CADTH Reimbursement Review process. Advice on RWE via the Scientific Advice Program is primarily for applications submitted in the pre-regulatory phase; however, requests ‘post-pivotal trial’ will also be considered where relevant.

In its press release, CADTH explained that all requests are required to include questions related to RWE generation plans, whilst questions related to ongoing pivotal trial(s) and economic modeling may be considered. All requests will be considered, but the availability of meeting dates will mean priority will be given to rare diseases or pediatric populations. Advice will also be provided in conjunction with Health Canada or the National Institute for Health and Care Excellence (NICE), where relevant, following established Scientific Advice processes. The Scientific Advice Program prior to finalization of pivotal trial protocols will continue to be offered and advice on RWE planning at this earlier stage will also be accepted.