From The Editor | March 14, 2024

How Takeda Leverages Cultural Competency Training To Improve Diversity


By Dan Schell, Chief Editor, Clinical Leader

Karen C Screenshot
Karen Correa of Takeda talks about the value of cultural competency training for PIs.

I'm not a fan of the term patient-centric as it pertains to clinical trials. Actually, it's not the term that I have qualms with or even the concept, but rather, how it has been appropriated by marketing teams to illustrate a “unique” value of a company. These days everyone is doing — or at least should be doing — something to incorporate the patient's voice into clinical trial planning.

A similar vagueness surrounds the word “diversity.” Like patient centricity, everyone agrees this is an important issue (i.e., increasing diversity in patient recruitment & trial planning), and everyone wants to position their company as a diversity “advocate.” However, saying you are focused on diversity and actually doing something about it are two different things.

In 2022, my predecessor, Ed Miseta, interviewed Takeda’s Karen Correa, Ph.D., BCMAS about various changes the company had made to improve communication and partnering with CROs, sites, and patients. Not surprising, among those changes were “…increasing the number of underrepresented patients participating in trials.” When I spoke recently with Correa, who is VP, head global clinical operations at Takeda, she got into some of the nitty-gritty of what they’ve been doing on the diversity front.


Correa admits that during her 30+ years in clinical research and operations, she has developed a real passion for understanding health disparities, health equity, and diversity. So when she would tell me things like how she was “super excited” about what Takeda did at their recent investigators’ meeting to help the PIs get more training, I could see that enthusiasm and passion coming through.

“We brought in a specialist to the meeting, and we had a whole training session on cultural competency,” she explains.  “Many of the investigators told us they were surprised at the level of detail the training offered.”

Correa’s account of that investigators’ meeting reinforced a message that Denise Bronner, Ph.D. of J&J explained to me in a previous articleWe need to re-educate and better educate physicians.

Considering Takeda is working on a new plaque psoriasis study, Correa used that TA as an example. “Say a PI is looking at a patient with darker skin who has plaque psoriasis. The imagery in their reference books/material may only show this ailment as being pink in color on light skin. But on a darker complexion, it may look more violet. Or, for someone who is Hispanic, it may have more of a salmon color.”

Not only did Takeda provide the PIs and study coordinators with different imagery showing a wide range of skin tones, the company also provided helpful information and examples on how to approach patients of color who would have a problem like plaque psoriasis. They ran through case studies and talked about appropriate questions to ask and how to respond. “This kind of cultural competency training and awareness for the healthcare providers and their staff can really make a difference when trying to recruit more diverse groups to participate — and stay involved in — clinical trials,” Correa says.

PAVE The Way To Diversity

The clinical industry loves its acronyms, and Takeda added a new one — PAVE — although it’s for internal use only. Correa says PAVE is key to understanding the company’s focus on health equity and diversity in clinical trials.

The “P” represents partnering, especially within the communities in which trials are run. The “A” stands for the company’s desire to “address” and find solutions to operational barriers of clinical trials. “The ‘V’ is the one I think a lot of us in the industry are thinking about”, she explains. “We want to ‘verify’ that our inclusive target number is focused on real world data — that's absolutely critical.  Currently, we are charting above the industry standard of having more than 25% of sites enrolling from a non-underrepresented population.” Finally, “E” stands for “enhancing” investigative site diversity.

Correa says this PAVE mentality has led to Takeda having diversity action plans for not just Phase 3 studies and other pivotal trials as FDORA (Food and Drug Omnibus Reform Act) stipulates, but for all trials started after June 2022.  

(Editor’s Note: The FDA is overdue in releasing its draft guidance on diversity action plans.)

“I like to think big when I think about the industry,” Correa concludes. “If we go work with organization A, church A, community A, for example, I hope that opens the door for other companies to work with all those entities. Because that’s when we change the dynamic and the story about pharmaceuticals. That’s when patients will truly believe in this industry, believe that we want to cure diseases and help people live longer. Those are our ultimate goals, and there’s no doubt in me that those are the goals of everyone at every company, regardless of  what drug they are working on.”