More equitable practices promised for pharmaceutical clinical trials

In Diversity in Clinical Trials Still Lags, we discussed some of the ways in which the medical manufacturing and trial processes have failed to be inclusive of non-White patients. From drug trials to the development of diagnostic devices, companies have systemically failed to include Black, Indigenous, and other People of Color (BIPOC) patients in their testing, trials, and product development phases, which either leads to or further exacerbates existing healthcare inequities. As a follow-up to that piece, we decided to look at some of the ways in which pharmaceutical companies have promised to address issues related to the lack of diversity in the medical community and in the drug and device development processes.

One of the first things we discovered is that virtually every pharmaceutical company has made some sort of statement about increasing diversity or addressing a lack of diversity in their processes. While there wasn’t really any set “start date” to this process, these statements generally started arising around the late-2010s/early-2020s and have focused on a relatively broad spectrum of ideas and issues.

In a recent BlackDoctor.org Facebook Live panel discussion, Dr. Ted W. Love, Chair of the Biotechnology Innovation Organization (BIO – the world’s largest advocacy organization that advocates on behalf of the biotechnical industry) said, “We are losing a lot of opportunity by having clinical trials underrepresent certain groups. We don’t get the science from studying those populations—and sometimes the science could be different, and we don’t know until we study it.”

This position is one of the primary reasons why patients, providers, and advocates alike have been calling for increased diversity in clinical trials and medical device development. Right now, “…we don’t know what we don’t know,” and that leaves us with a largely and unacceptably imperfect system where medications are optimized to treat primarily White European patients when White Europeans are not, in fact, either the largest patient population or, in many cases, the patients facing the highest risks of transmission, complications, or misdiagnoses.

Dr. Love continued by saying that “…many physicians…have a negative view of even recruiting people of color in their clinical trials,” and so those patients are simply not asked to participate. In J.P. Carroll’s latest piece in Bio.News, he explains the pitfalls of failing to include a diverse patient population as a matter of practicality. When we have diverse populations in clinical trials, we get better treatment options, or we discover that some treatment options work well in certain populations but not in others, which leads us to develop treatment options that do work in the “other” patients.

Genentech, a San Francisco-based biotechnology company that works to develop and discover medicines for people with serious and life-threatening diseases, tells us that they (and we) need to “Ask Bigger Questions,” and tries to shift the narrative away from the important, yet simplistic questions we tend to ask, and toward broader questions that underpin these issues. For example, instead of asking, “Why are clinical trials so slow,” Genentech asks, “Why are clinical trials 85% White;” instead of asking, “How can we improve cancer care,” Genentech asks, “Can we improve people care?”

Genentech’s mission with this campaign is to work on addressing the underlying issues of systemic racism, a lack of direct and effective outreach into minority communities when seeking clinical trial patients, and other pressing concerns that have plagued the healthcare field since its inception.

We know that Genentech actively seeks to partner with minority-owned and -led Community-Based and Faith-Based Organizations (CBOs and FBOs, respectively) in order to better reach potential patients where they may be unable to do so on their own. Their work in the cancer space related to improving access to and utilization of genetic and genomic testing among BIPOC patients has been excellent and they have actively supported and empowered the voices of incredible organizations and advocates, such as Touch4Life and its Founder and President, Laura Crandon. Touch4Life is a Black-owned, -led, and -operated organization that focuses on increasing breast health IQ in BIPOC communities where rates and health outcomes for breast and other cancers are far worse than for their White peers. Genentech’s support of Touch4Life and Miss Crandon has allowed her organization to reach over 5,000 people in need of information and support where the existing medical and care communities have failed to have a presence.

So, we know that Genentech is, for all intents and purposes, keeping its promises. But, what about other companies?

Merck published a blog in December 2022 that laid out very specific steps they plan to take to address diversity issues in clinical trials, including:

• Implemented a new process that requires diversity plans (actionable steps) across all late-stage clinical trials.

• Prioritized selection of U.S. sites in diverse communities by using census data.

• Developed various partnerships with community organizations, colleges and universities, and professional organizations to expand outreach to people from different genders, races, ethnicities, and sexual orientations. Examples of the organizations with whom Merck is collaborating are:

  • Greenphire to help reduce financial and travel barriers for clinical trial participants globally.

  • BlackDoctor.org on its Clinical Trial Resource Center, which is an online repository of information regarding clinical trials specifically for the Black community.

  • A network of Diversity Sites in the US, including HBCUs via the Beacon of Hope, which is an initiative created by Novartis and the Novartis U.S. Foundation to create greater diversity, equity, and inclusion across the research and development ecosystem. Merck operates clinical trials through four Historically Black Medical School clinical trial Centers of Excellence as part of the initiative.

  • Association of Clinical Research Professionals (ACRP) to provide access to training for clinical research sites located in historically underrepresented communities and for community college and high school students in these communities interested in the clinical research profession (Merck, 2023, Public Statement Correspondence).

• Formed a community advisory panel this year to offer insights on overcoming research trust, trial barriers , informed consent, recruitment, and retention strategies.

• Invested in training and tools for researchers, our teams, clinicians, and others at clinical trial sites to address the need for broader clinical trial access (Merck, 2022).

These action items appear to be working, according to Merck:

Our approach is working. In 2022, approximately 50% of our clinical trial patients were from diverse backgrounds – both in the U.S. and globally.

But we need to do more. Our diversity & inclusion in clinical trials team is focused on increasing access to clinical trials in the U.S. and will expand those efforts globally (Merck, 2022).

So, Merck has demonstrated that they are going to hold themselves accountable for their promises. Another excellent start. And yet…

As we conducted outreach during the information-gathering period of writing this blog (a process that began in late May and continued through July), we found that few companies were willing to answer questions about their initiatives or provide updates on any progress they’ve made toward achieving their stated goals and commitments. Even when we made it clear that the purpose of this article was the highlight the good work being done by pharmaceutical companies, we were met with a dearth of willingness to respond to our inquiries.

That is not to say that we received no responses; rather, we found that companies tended to be reluctant to speak about their outcomes. While they provided no reasons why, we have come to believe that this may be a way to avoid being lured into speaking with a writer only to have their words twisted to portray the company or its efforts in a negative light. And, frankly, they have good reason to be concerned on that front:

All too often, we see healthcare non-profits lambasting pharmaceutical companies for their lack of diversity and inclusion efforts. No effort is ever good enough, diverse enough, or listens to the “right” people, and any efforts to engage the “right” people are often met with either skepticism or outright hostility. We see this in the HIV space, the Harm Reduction space, and other public health spaces. It seems to be a self-defeating exercise where we demand more inclusion and a seat at the table, but refuse to sit at the table with the people from whom we demanded a seat.

During our information-gathering process, we did receive a statement from the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group that represents pharmaceutical companies in the United States:

Equitable Breakthroughs in Medicine Development is a comprehensive effort to increase diversity in clinical trials and address systemic barriers to participation by communities of color. This effort seeks to help underrepresented patients be more involved in the research and development of potential life-saving medicines. Funded by a grant from PhRMA, Equitable Breakthroughs in Medicine Development works to bring together diverse communities, patients, providers, health partners, community organizations and academic institutions, along with the support of the pharmaceutical industry, to pilot a network of sustainable, connected, community-based clinical trial sites.

Both PhRMA and individual companies have efforts underway that highlight how a community-based infrastructure is critical to help enhance participation of diverse populations in clinical trials. These collective efforts take time and ongoing resources to create a sustainable approach towards tackling the systemic barriers that often stand in the way of people participating in clinical trials, particularly people from underrepresented populations in underserved communities (PhRMA, 2023, Public Statement).

This is, to some degree, part of the problem:

There are a lot of promises being made, but not a lot of transparency in the processes being used to achieve the stated goals or about the progress companies have made.

At a recent gathering in Nashville, Tennessee, a person from a pharmaceutical company not listed above posed the following question when discussing diversity in clinical trials:

“Do you want clinical trials to be fast, or are you okay with them taking three to five years?”

To that question, there seems to be only one acceptable response:

“I want medications that are proven effective for people from every racial demographic, and if a drug doesn’t work as well in Black people, I want us to find or develop one that does.”