Addressing Underrepresentation of Racial & Ethnic Groups in Psoriasis Trials

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 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: What specific strategies is Takeda implementing to address the disproportionate underrepresentation of racial and ethnic groups in clinical trials, particularly in its Phase III psoriasis trials and beyond?

LaShell Robinson: As the head for global feasibility and trial equity, my day-to-day job is focused on making sure that all of our trials have the representation of patients that reflect the real world, including these psoriasis trials. It goes without saying that our ambition from the very beginning was to ensure that our phase III trials for psoriasis had better reflection of the real-world patient population, because we did see a gap. When we were looking at the real-world data, we noticed that things like under diagnosis, longer treatment paradigms, or longer pathways to diagnosis also impacted the people that were represented in our clinical trials. We wanted to ensure that from the very beginning, we were really thinking about this and implementing our tested, tried and true PAVE strategy, which is our strategy to make sure that underrepresented and underserved populations are included in our trial.

First, our P is partnering with community stakeholders. We partnered with organizations such as Inside Edge, Black Health Matters, and Hispanic Communication Global Network to ensure that we have better engagement with communities that were underrepresented and underserved, specifically for psoriasis. These organizations have tried and true relationships, and we were able to leverage that to connect with patients in a more authentic manner, not only educating them about psoriasis, but also around the importance of them participating in clinical research and how that helps contribute to better science.

We have the A, which is addressing operational barriers that impede patient access. This is where we spend a lot of time around planning, operations, and looking at the protocol. One of the things that we did immediately was incorporate multicultural imagery. We know that most of the imagery for plaque psoriasis is of patients that are white. The impact that has is it creates a longer diagnosis pathway, we see gaps in the teaching around dermatology, etc. We wanted to make sure that we had multi-racial and multiethnic imagery with skin-of-color and multiple images represented so that we could start closing that gap. We also did careful site selection, where we prioritized sites that had a broader reach and patient representation in our feasibility process. We even went so far as to ask our sites to tell us about the demographics of their patients so we could prioritize the selection.

Then V is verifying that any goal we had around representation was truly reflective of the patient data. One of the things we saw at the very beginning is even though psoriasis is one of the most common skin disorders, there's a lack of epidemiology data that is specific to race, ethnicity, and gender breakdown. One of the other elements that we did in addition to looking at literature review and epidemiology was ask our sites what their real-world patient population is and used that to actually develop a goal that we felt was more reflective of the patients with psoriasis.

Then finally E was enhancing the diversity of our investigative sites. This is where we really deepen the education and sharing the best practices to support more accurate diagnosis of psoriasis in skin-of-color at the very beginning. We offered sites multilingual toolkits where they could actually discuss what the general sense of clinical research is, and how it transmits to our particular trial. We even had an investigator do a session at an investigator meeting. This is where we pull all of our sites and those participating together to really educate them on the protocol, give them the opportunity to ask questions, and use the opportunity to share best practices around diagnosing skin-of-color. In fact, we had two sessions that were dedicated to that, so that at the end of the day our sites were very well prepared. We're also thinking a bit differently around how they could connect patients that are traditionally left out of research.