Oncologist, daughter develop strategy to make cancer clinical trials more inclusive

August 25, 2022

5 min read


Ruemu Birhiray reports a speakers bureau role with AbbVie, Amgen, AstraZeneca, Daiichi Sankyo, E.R. Squibb & Sons LLC, Exelixis, Janssen Biotech, Eli Lilly & Co., Glaxo Oncology, Incyte, MorphoSys, Pharmacyclics, Puma Biotechnology, Regeneron, Sanofi and Seagen; and an advisory board role with Array Biopharma, Epizyme, Janssen Scientific Affairs, Lilly Oncology, Regeneron and TG Therapeutics. Maya Birhiray reports no relevant financial disclosures.

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Key takeaways:

  • An oncologist and his daughter, who plans to be a pediatrician, developed a plan for diversity and inclusion in cancer clinical trials.
  • The plan, called DRIVE, outlines practical ways of encouraging greater diversity in enrollment and among research teams.
  • The initiative will culminate in a “black paper” to be developed in conjunction with key thought leaders and patient advocates.

When it comes to their approaches to work, Maya Birhiray, BS, and her father, Ruemu Birhiray, MD, have very different styles.

“I’m very much a person who outlines something 10 times before I write anything down,” Maya Birhiray, a graduate of Purdue University who plans to pursue pediatric medicine, told Healio. “My dad likes to sort of throw things at the wall and see what sticks. We kind of even each other out.”

Maya Birhiray
Ruemu Birhiray

Ruemu Birhiray

This commitment to embracing differences and working together is at the core of their latest collaboration, a study aimed at increasing diversity in cancer clinical trials.

In the study, published in Blood Advances, the Birhirays found that only 7.8% of 230 clinical trials between 2008 and 2018 reported representation of white (76.3%), Asian (18.3%), Black (3.1%) and Hispanic (6.1%) participants. The data reflect substantial underrepresentation of Black and Hispanic individuals compared with their proportion of cancer incidence in the U.S., they wrote.

To address the issue, the Birhirays will host the “Indianapolis Black Paper Summit,” which will bring together representatives of the FDA, ASCO, ASH and other thought leaders, as well as patient advocates in the hematology/oncology community, on Sept. 9. The assembled group will develop a “black paper” based on the ideas outlined in the Birhirays’ study.

“We’re calling it a ‘black paper’ as a tongue-in-cheek way of saying it’s the opposite of a white paper,” Ruemu Birhiray, clinical oncologist at the Hematology Oncology of Indiana division of the American Oncology Network, told Healio. “However, we’re not representing any specific race. We’re bringing people in the field of oncology together with the goal of reaching a consensus.”

‘A ripple effect’

Maya Birhiray recalled the importance of discussing racial injustice in her household growing up.

“The Martin Luther King holiday was always a big holiday in our house, and learning about the civil rights movement, the African diaspora and things of that nature has always been really important to my family,” she said. “I’ve always wanted to be a physician, and during my time at Purdue University, I was exposed to a lot of student organizations that are pushing for diversity on campus. So, as I was hearing my peers talk about these things, I’ve been discussing them with my dad. The whole thing came naturally from conversations we were having.”

Those conversations resulted in the development of DRIVE, a series of practical strategies for encouraging diversity, equity, inclusion and access in cancer clinical research. DRIVE is an acronym representing the different components of the Birhirays’ diversity and inclusion plan:

  • Diversity officer for clinical research studies;
  • Ranking of clinical studies for diversity;
  • Individual diversity, equity, inclusion and access plan;
  • Verification of study diversity; and
  • Elevate and enhance training of minority investigators and research team members.

Maya Birhiray discussed the role of the diversity officer, who would oversee the study and ensure that diversity efforts are being carried out.

“This would be a point person whose responsibility it is to make sure, every step of the way, that concrete goals are being achieved,” she said. “It’s one thing to say, ‘We have these goals and we’re going to achieve them,’ but have no plan and then wonder why nothing was achieved. The diversity officer would look at everything with a fine-toothed comb and determine where the study might be falling short.”

Ruemu Birhiray devised the idea of ranking studies on their level of diversity based on the World Bank’s ability to effect change. He said he contemplated the ways in which large organizations bring about change. The first way — to enact legislation that would enforce diversity — didn’t seem as realistic.

“The World Bank has an outsized effect on countries without necessarily having the legislative ability to change what they do. Instead, it leverages what it has the ability to do — to lend money,” he said. “In this way, it can prompt countries to adapt and to change for the good of their citizens. I felt that was something that could work in medicine. The currency in research is the much-desired podium presentation and the prestigious journal publication. Ranking could be powerful because nobody wants to be ranked at the bottom.”

The individual diversity plan serves as a reminder that although improvements in diversity often can be achieved at the leadership level, it hinges on each individual’s commitment to change, Maya Birhiray said.

“This idea leans into the fact that huge community administrative change is going to be great, but individuals obviously also need to be aware of what they can do differently,” she said. “Individuals need to be thinking about how they can increase diversity, not only in their practice, their research or their clinics, but also as an individual. That’s how we really make mass change. It’s a ripple effect.”

Verification of study diversity could be implemented in a stepwise manner, Ruemu Birhiray said. Through this approach, investigators would report on the diversity of their studies, and this reporting would later be verified through an auditing process.

“You could imagine it as a sort of Good Housekeeping seal of approval,” he said. “We would be able to know, based on this verification, whether a drug that is approved had sufficient minority enrollment in their study.”

The last component of DRIVE is devoted to ensuring that members of the research team represent the populations being studied.

“It’s not just the principal investigators, but even the research team members,” Ruemu Birhiray said. “I remember talking to a colleague who said, ‘It’s so hard for me to enroll minority patients in my studies.’ I asked him, ‘Do you have a coordinator who looks like the patients you’re trying to enroll?’ The answer was no, and he had never thought about that. We want to focus on training investigators who represent the diversity of the population we are enrolling. We want them to be able to see people who look like them.”

‘Shocking and inhuman’

Maya Birhiray said until clinical trial enrollment becomes more equitable, the scientific findings of some studies will inevitably be flawed. Their paper cited that between 2008 and 2018, only 7.8% of clinical trials documented the four major races (white, Asian, Black and Hispanic).

“From a scientific perspective, I don’t see how we can expect a medication or treatment to work in a population that we haven’t tried it in,” she said. “In the very recent past, pharmaceutical companies and researchers realized they were studying medications on male bodies, and then in the real world, women were taking them and having completely different side effects. That was the very recent past. So, we learned that lesson, but not all the way.”

Ruemu Birhiray said Martin Luther King Jr. summarized his and Maya’s mission when he said, “Of all the forms of inequality, injustice in health is the most shocking and inhuman.”

The two of them have set out to eliminate that.

“I also like to paraphrase what Abraham Lincoln said when he stopped in Indianapolis on the way to his inauguration as president: ‘It is we the people of the United States, not government, not senators, that make the difference in our lives.’ When you bring all of that full circle, I think that’s what we’re trying to do here.”

For more information :

Ruemu Birhiray, MD, can be reached at 8301 Harcourt Road, Suite 200, Indianapolis, IN 46260; email: [email protected]

Maya Birhiray, BS, can be reached at [email protected]

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