From real-world evidence to regulatory wins

Real-world evidence plays an important role in helping clinicians make treatment decisions. It complements the data from clinical trials and provides perspective from a more broad real-world setting on the safety and effectives of drugs.
Expertise
Health

Challenge

Our clients are constantly looking for ways to integrate new and impactful data into their brand messaging. However, many trials, particularly those based on real-world evidence (RWE), traditionally fall short of meeting PAAB’s stringent evidentiary requirements for efficacy claims. The introduction of PAAB’s RWE guidance presents a critical opportunity to present this data in a compliant manner. While the guidelines are comprehensive, they also leave room for interpretation, making it essential to navigate the nuances to ensure regulatory approval. 

Insight

Recognizing the need for a structured approach, we identified an opportunity to create a framework that would enable cross-functional teams to rigorously evaluate RWE studies and pressure-test them against the PAAB RWE guidelines, ensuring alignment across commercial, medical, regulatory, and legal functions for the best chance of success. 

Execution

We developed an evaluation framework to methodically assess RWE studies, ensuring alignment with every aspect of the PAAB RWE guidelines, including consistency with the Terms of Market Authorization (TMA), patient population, endpoints, and methodology. This framework streamlines alignment across all relevant teams, ensuring a unified approach to messaging and documentation to support PAAB’s review of the study and proposed claims. It also helps identify potential gaps, allowing teams to prepare for potential challenges early on.

Results

Clients who have adopted this framework have reported significant improvements in efficiency when coordinating cross-functional teams. They have expressed increased confidence in their ability to demonstrate how studies meet PAAB’s RWE requirements and, ultimately, secure approval.

PAAB data suggests that the success rate for RWE submissions is around 30%. By applying our methodical, evidence-based approach, our success rate has been double that—reaching 60%. This underscores the effectiveness of our framework in helping clients compliantly integrate new data into their brand messaging.

* Data from PAAB, November 2024

Land acknowledgement, truth and reconciliation action plan

ChangeMakers offices and team members are located across North America within the traditional, Treaty, and unceded territories of First Nations, Inuit, and Métis Peoples.