Clinical Trial Diversity Inclusion is Becoming a Socially Responsible Initiative

Clinical trial inclusion in the biopharmaceutical industry had been driven primarily by federal initiatives. However, there seems to be a renewed strategy in big pharma to incorporate diversity inclusion in clinical trials. For example, Eli Lilly has discussed its clinical trial diversity inclusion strategies, which seems to be driven by social injustice. Now, Genentech/Roche is taking on diversity inclusion as a socially responsible strategy. In this interview, Nicole Richie, Global Head Health Equity and Population Science at Genentech/Roche, will discuss her perspectives on the topic.

Moe Alsumidaie: Can you tell me why Genentech formed the Advancing Inclusive Research Site Alliance, and what was the motivation behind this? What sparked this initiative, and why now?

Nicole Richie: We started this work several years ago with the appreciation that clinical trials are homogeneous and that the majority of patients included in clinical trials are of one race, and ancestral background—only five to 15% are not Caucasian. A couple of reasons this was front of mind was, for one, the United States demographics are shifting—we are becoming a more diverse and minority-majority nation. The second element that caused more of an increased focus internally was that we thought about personalized healthcare and invested in that as a pharmaceutical company. With that came this burgeoning awareness in the clinical and scientific communities that genetic and clinical data are homogeneous.

All of the information that’s readily available to us is limited. And the implications of that as we try to develop more and more personalized treatments are significant. It undermines our ability to have more personalized care. And so there was just this kind of bolus of publications and literature around this.

That tipped us into having more of a discrete focus on this work back in 2017. As it evolved, we realized that one of the mechanisms to have more representation in research is by having sites in the right location, with the right capabilities and the proper outreach into patient communities. That is where this focus on an Alliance model was born. It was intended to create an infrastructure that will allow for sustainable and durable commitment and a building of partnerships to have more representative patients in our trials and our research environment. We started with four sites, with the aspiration of having a network that ultimately serves these cohort centers of excellence and partners with us to achieve our aspirations for diversity in clinical research.  

MA: How does that fit with Genentech’s overall product development strategy? You mentioned personalized medicine, and of course, Genentech is big on oncology. Does that have something to do with that? Or is it more of a federal or social mandate that you’re following?  

NR: It is to bring more representation into our clinical trials and to bring greater real-world data cohorts, both clinical and omic, into our strategies and planning and our process that informs our personalized healthcare approach. And then to partner strategically across the healthcare ecosystem with the appreciation that this is a big challenge, and we have to come together in different ways to integrate new solutions.

This work, in general, is about having more representation in our research programs. Roche is fully supportive and synergistic with our aspirations for personalized healthcare, as they align with many of Roche’s vision as a pharmaceutical company to impact patients’ lives. By moving into a more comprehensive solutions-based approach, and not a transactional medicine, we we can impact patient care in an end-to-end manner.

Then, we also think about what our impact on society is. So we are asking questions like, “How do we reduce the burden for society?” Healthcare costs are unsustainable, and this is not a new problem, but as institutions and stakeholders continue to move more and more towards value-based care, these types of solutions and integrating the totality of health becomes front and center to what a pharmaceutical company needs to focus on.

So as such, this is a crucial component to broadening the lens on who informs our science and medicine and who benefits from our innovations. And it’s also coupled with our “Bench to Bedside” efforts that are happening across the organization. So it is the research endeavors, but also making sure that we partner holistically with the access pathways to ensure that we’re bringing not just research, but enabling science understanding in under-studied patient populations and ensuring that patients get served in new ways and have access to these innovations.

MA: What does the diversity currently look like with Genentech’s trials, and what milestones do you have to increase the diversity, and what does that mean for clinical trials?

NR: Currently, you can look at the last new molecular entities that were published on FDA Snapshots. The metrics are getting better, and the most recent NMEs were approved with the caveat that these are global trials and comprised of different countries enrolling at different rates. So what used to be upwards of 90% of all European or white patient demographics has moved to around 75%, and in some cases even less than that.

So that population that’s growing in some cases is through China. We are doing more and more studies in China, and we’re bringing in more Asian patient populations. We still have much work to do, I would say, in bringing in African American and Black patients and Latin and Hispanic patients, both in the US and Latin America, for example.

The demographics of the studies have to be viewed within what recruitment occurs in the US versus outside of the US if we compare to US metrics. So, for example, in our most recent geocentric approval, the representation of US recruitment is very much in alignment with what you would expect for the epidemiology of disease. However, if you look at the whole global population, it gets diluted that the minority of patients come from the US.

It is contextual as we think about benchmarking and baselining. We are using epidemiology as our metric of what we’re trying to drive towards. We are putting together an understanding of where we were before, so looking at that historic recruitment is a first them. Then, our goal will ultimately be to align to the epidemiology of disease and what we would expect based on demographics. Those are the metrics we’re trying to achieve as we think about what “good” looks like. This is a long process because recruitment, depending on what therapeutic area you’re talking about, takes several years of integrating mitigations or implementing new tactics that, over time, move the needle.

We have seen some great examples in our EMPACTA study. The study was conducted during the COVID-19 pandemic, and it included patient populations in the US. Approximately 84% of patients were non-White and from places worldwide, including Latin America and Africa, and in the US like the Navajo nation and New Orleans, where patients were disproportionately affected by the disease.

We had to show with that study that it’s possible, and we can find these patients. If we can do it in a global pandemic, I’m sure we can think about how to do it more holistically. So many learnings have come from that. There have been several proofs of concepts that have shown what we can achieve. Now it is a matter of how we bring it into the whole totality of the lifecycle of development.

MA: I understand you have global partner trial sites. Can you tell me more about those partner trial sites and how they are working successfully to include diversity while also de-risking it as much as possible?

NR: Absolutely. That is undoubtedly the plan. We launched the first-ever oncology industry study in Kenya this year. So there are sites that have that high rigor and that fidelity that is necessary, but we don’t typically think about them in that way. From the global vantage point, we’ve been thinking about where those patient populations are particularly understudied. So you end up in Latin America, Africa, India, these vast regions. With the appreciation that, to your point, we have to have an infrastructure that serves us.

In a similar manner that we have established the Advancing Inclusive Research Site Alliance model in the US, we are looking at how we can do something that’s probably quite different in the actual tactical planning but has the same intentionality. So that we again create this infrastructure that is a center of excellence and has fidelity, conveys trust, and creates partnerships that can be forged over time and then maintained.

The other thing we’re looking at is how Europe and the UK are rapidly diversifying, in certain regions more than others. So really, it takes much global strategy with local implementation and information, which is typically how we do things. So it fits right into our current operating model.

MA: Can you tell me about the disparities in clinical trials? What can the pharmaceutical industry essentially do to bridge that gap? Or at least try to bring that gap together through bringing those innovative and breakthrough medical products to those patients?

NR: I think there are a couple of elements. As a pharmaceutical company, we can intervene in many ways from a research and data generation perspective. We are moving into real-world data and other forms of information that we can use to supplement and facilitate our understanding of populations that have almost entirely been understudied and left behind by science and medicine.

There is a commitment to leveraging more considerable data assets to generate insights and contribute to scientific discourse in a new way. We’re trying to achieve population-specific medical elements based on the appreciation that disease affects populations differently. For example, there are well-known variations in clinical course and even response to therapy due to therapeutics attributed to race, ethnicity, and genetic ancestry.

As a science company, we have to get the science right. But, we also have to think about health equity, access, and the totality of health. I think that’s deeply at our intersection of how we think about personalized healthcare.

Because research is just one piece of the broader health continuum, there is a leadership element to showing and setting industry standards on addressing health equity.

We must partner in new ways across the ecosystem, which we currently do in many different avenues through charitable giving, for example. We also do so through our External Council on inclusive research and health equity, which includes key opinion leaders that are very established in the health equity space representing healthcare professionals and patient advocacy groups and organizations.

Our role as a biotechnology company is twofold. Firstly, it is to get the research and the science right, increasing the clinical utility and results generation. Secondly, we need to make sure that we address access deprivation and the channels needed to ensure that patients are getting access to our medicines.

We also have to put a line in the sand with public declarations of our intention, hoping that we will instill that in other companies. Because it will take all of us coming into this space to achieve more remarkable health outcomes for more patients. Ultimately it’s also to mobilize the industry and enterprise at large.

MA: The Advancing Inclusive Research Site Alliance is one of the many examples of what Genentech is doing as a trailblazer in the industry. How do you anticipate that the biopharmaceutical industry will also change to address diversity?

NR: Hopefully, this is setting the standards. We are very active in pharma trade organizations and other cross-industry collaborations, and we are even publishing our approach and methodology. For example, the Advancing Inclusive Research Site Alliance announcement shared how we’re thinking and what infrastructure and foundational elements we’re putting in place are serving us well.

One of the things I like about our approach is that it is very much in Genentech fashion to partner with experts. So this is where again the External Council comes in. We have these incredible minds who have been in this space for decades and can help challenge us and inform our process. So there are tangible outcomes from that.

For example, on the council, we have an incredible multiple sclerosis (MS) clinician who has observed that the clinical course and outcomes look different in Hispanic and Black patients. So, as a result, we now have a study called CHIMES to address this specific hypothesis in Black and Hispanic patients. It goes to show that in pure Genentech fashion, we’re harnessing the best and the brightest because we know that this is bigger than just one company. We understand that this is a substantial multifaceted challenge, and we have the humility to say that that is the case.

There is no magic bullet. This takes much learning and much iteration, and it’s probably different across disease areas, as we’ve come to appreciate as well.

I think the leadership element of this also comes in the fact that we resource it. I have a team of people that focus on this that serve this work globally. Quita Highsmith, our Chief Diversity Officer, has a strategic pillar concentrated on this. There’s a US medical affairs group focused on health equity and inclusive research. Both of our research institutions in Genentech and Roche have cross-functional teams that have come together around this. So I think it all comes back to giving it time, space, money, and funding.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.