Improving diversity in clinical trials is a critical goal for the biopharmaceutical industry — but to ensure that our work yields innovative medicines for all people, we have to start earlier, in the lab.
As head of Diversity and Inclusion for the Novartis Institutes for BioMedical Research (NIBR) — the early-stage research hub and innovation engine of Novartis — I am charged with ensuring that we account for D&I in our science and the activities that support it. This means taking diversity into account long before a potential therapy enters the clinic — recognizing and rooting out social biases that could skew our research, and lowering barriers to inclusive collaboration.
As an industry, to make our research truly diverse and inclusive, we must:
1. Start with inclusive patient data
If we inadvertently train our advanced analytics with biased data, it will produce biased models. For example, powerful studies are revealing that patient genetics can influence how safe and effective treatments for life-threatening diseases may be. But the genome-wide association studies these insights are based on are far from diverse — the vast majority of participants in these studies have primarily European ancestry. If we rely on databases that focus exclusively on one type of ancestry, we miss opportunities to design safe and effective treatments for all patients. By starting with more diverse and inclusive patient data, we can both uncover novel biology and keep a wider range of ancestral backgrounds in scope when designing treatments. We must also support research and validation of existing data standards that drive diagnosis and shape clinical trial endpoints. There is increasing evidence that some medical tools can inadvertently contribute to discrimination in the US health care system if the underlying software is not developed using adequately representative data. To course-correct, we need to involve more people of color in the design of biomedical studies and technologies, not only as research participants but also as scientists.
2. Challenge foundations of our knowledge
Too often, underlying assumptions about patients and diseases are based on social generalizations not founded in biology. This leads to characterizations that poorly reflect reality and the richness of our global ancestral diversity. Sickle cell disease, for example, is often defined, explicitly or implicitly, as a “Black disease.” In comparison, malaria, endometriosis and pre-eclampsia are not, even though they also disproportionately affect people labeled or self-identifying as “Black.” Instead of relying on outdated, proxy classifications, we should challenge the foundations of our knowledge and the ways we think about genetic and cultural ancestry. For instance, studies have repeatedly shown that higher genetic variability exists within racial groups than between them. And social groups are not static; they evolve over time to include a mix of physical, geographic, cultural, and religious factors. We need to shift conversations from racial and social groups towards personalized medicine approaches based in actual patient biology.
3. Be inclusive when it counts the most
Building diverse teams is necessary for any organization. But it’s not sufficient. We must also identify where the most important decisions in the organization are made and ensure that diverse perspectives are represented in these make-or-break moments. If we believe that good ideas can come from anywhere, it’s not enough to simply say it; we must practice what we preach and be inclusive and “innovator-agnostic” when it counts the most. This includes building the ability to have discourse on opposite views, which we know is important for innovation. Embedding diverse perspectives in all levels of an organization — and staying curious, open, and respectful to all — helps to ensure that we can capitalize on our collective intelligence.
4. Ensure that innovation benefits everyone
Historically, the primary beneficiaries of innovation have been highly educated or otherwise privileged groups. The pattern often starts with an unconscious assumption that advances in technology alone are sufficient to improve health, and with less conscious regard for the influence of social factors on our scientific and business decisions. To avoid unintentionally reinforcing health disparities, we should take social determinants of health into account from the beginning of the drug design process, to better ensure that innovation benefits everyone. By first considering how to ensure consistent and broad access to a new technology, we can design that technology so the barriers to access are lower. At NIBR, this means ensuring that we develop treatments for diseases that affect patients in a wide range of geographic and economic settings. It can also mean re-inventing technologies and therapies from the ground up.
There is still a tremendous amount of work to do to ensure that biomedical research is diverse and inclusive down to its foundations. But these four steps can take us a long way.
Learn more about how we are promoting diversity and inclusion at Novartis.
Anastacia Awad, Ph.D., is the head of diversity and inclusion for the Novartis Institutes for BioMedical Research (NIBR).