Novartis CEO Vas Narasimhan, M.D., sat down with Stephen Ubl, CEO of PhRMA, to discuss the pharmaceutical industry’s commitment to increasing clinical trial diversity and the efforts Novartis is making. PhRMA is an organization representing top innovative biopharmaceutical research companies in the US, committed to discovering and developing medicines to help patients. Below is a condensed version of their conversation.
Stephen: [Last year] PhRMA announced the first ever industry-wide principles on clinical trial diversity, which is a critical component of health equity. Why is this industry effort so important in improving diversity in clinical trials? Why does it matter for patients?
Vas: When you think about clinical trials and why we want diversity in clinical trials, there’s a few big reasons on my mind.
One is we need to study populations where we ultimately use our medicines to understand the efficacy and safety of these medicines. In many cases, we learn, often after the fact, that we can see different profiles of medicines, depending on race, ethnicity, genetic factors, etc. ... It’s absolutely critical we get a diverse patient population in our clinical trials that reflects the world, and that reflects the diversity of the United States.
A second element is that we know that when you do clinical trials in healthcare systems, you build a positive ecosystem to adopt new technologies. Clinical trials are a critical element in continuing to raise the capabilities of healthcare systems, train clinicians, and enable those clinicians to use the most modern and advanced medicines to treat patients in those communities. So I believe clinical trials can be a powerful lever to also improve the healthcare ecosystem in Black and Brown communities ... [and] in diverse communities in the country.
And then lastly, we know it builds trust. And we need the trust of society behind our medicines. And having diverse clinical trial participants enables us to build trust with communities to get these medicines taken up by the patients who need them.
I believe clinical trials can be a powerful lever to also improve the healthcare ecosystem in Black and Brown communities ... [and] in diverse communities in the country.
Stephen: What are some of the barriers to getting to where we need to go on clinical trial diversity?
Vas: ...There’s a long history here. And of course history shapes, in many ways, the current situation that we’re in. Unfortunately, there was the loss of trust in many communities behind participating in clinical trials, particularly, importantly in Black and Brown communities and understandably so.
Another critical element is I think we – as a medical, academic complex – have not done enough to train investigators from these communities to be able to participate in clinical trials. It does take investment, it does take training, it does take know-how to participate in what are actually very advanced undertakings, complex undertakings. And we need to do more. And that’s one of the elements of the program that we’ve set out.
And then lastly, I think there's a big element of patient education and community education to really build that underlying trust to want clinical trials to happen in these populations.
Stephen: What do you see as some of the best practices ... whether it's in Novartis or as we look at the broader industry, best practices that you think can help us get to where we need to go?
Vas: I think there are a lot of things we’re learning as we go through this. Probably the most important thing is to be consistent. And I think I’m hopeful now, in the current context, that whatever we do, we do it consistently over time. Because there are no quick wins to building broader clinical trial diverse patient populations and investigator pools.
I think trying to engage with communities around specific diseases of interest can also be a powerful way. ... We have a program called Generation S where we've been able to use social media to engage sickle cell patients to build more trust, more interest in sickle cell clinical trials, get better therapeutics.
So I think each one of these has a role to play.
Stephen: As you think about hard-to-reach communities and community engagement, what do you think are the keys for our industry to reach into those communities and really build trust and move us forward?
Vas: I think a lot of it starts with listening. I think we have to listen to the stakeholders in that community, probably something we’ve not done well enough historically. Whether those are patient groups, whether those are hospital and physician communities in those centers, community advocates. I think there’s also more we can do with the medical education systems. I know some of our member companies have launched major partnerships with historically Black medical schools. I think that kind of engagement with educational systems that can hopefully then raise the next generation of physicians who are comfortable working on clinical trials ... will only help us get to a better place.
Vas Narasimhan reflects on a commitment to increase clinical trial diversity