Ensuring Representative Psoriasis Clinical Trials on a Global Scale

In this Pharmaceutical Executive video interview, LaShell Robinson, head of global feasibility and trial equity at Takeda, discusses strategies to address underrepresentation in clinical trials, particularly in phase III psoriasis trials. Robinson also discusses the company's partnerships with community stakeholders like Inside Edge, Black Health Matters, and Hispanic Communication Global Network to improve engagement, address operational barriers, and prioritize sites with diverse patient demographics. Takeda has also enhanced investigator diversity through multilingual toolkits and educational sessions, and aims to expand these efforts globally by adapting strategies to regional needs.

Pharmaceutical Executive: Beyond the US, how is Takeda addressing the need for representative clinical trials globally, considering the 60 million people worldwide living with psoriasis? Are there unique challenges in different regions?

LaShell Robinson: The US definitely has very specific aspects around trial diversity, and that doesn't necessarily translate to every single region. Takeda intends to expand those efforts by drawing on that US strategy framework, but making sure that it's adapted to what is most important per country or region, specifically when it comes to talking about the patient perspective. What does underrepresented or underserved mean in a particular community? That could vary in the US. It could be race, ethnicity, gender, or even location.

When we start looking at the other parts of the world, it could even be how they're accessing healthcare. Gender or sex tends to be a factor that consistently plays a role that we're seeing regardless of geography, so that will be one of our areas of key focus as we start to broaden this into other geographies. While we have this global problem, it's extremely important that we're taking the time to understand what it means from a patient perspective in that region, and that's how we'll start expanding globally.

PE: Can you provide examples of how Takeda is ensuring that the data collected from these more diverse trials is translated into improved real-world outcomes for patients?

Robinson: The first part was ensuring that our trials were representative of real-world patient populations. It can become difficult to even talk about outcomes if we don't have that inclusion. We're looking at this as a way to serve the patients that we aim to treat so that we have better outcomes from patients. We've studied how different populations may respond to different therapies, but that's usually after the drug is approved. We wanted to make sure that we're taking that into account in the context of our trial.

One of the aspects that we're really looking forward to is Takeda is also working to share the epidemiology data that we've collected to better help and support further research and understanding in the area. Stay tuned for that, because directionally, that can really help different areas of understanding in this area.