Taking a 360° approach to embedding diversity and inclusion in the clinical development ecosystem

“I’ll do it because I trust you want the best for me.” This response from an African American patient stuck with me from when I was a practicing physician over 20 years ago. It says so much about the importance of the relationship between a doctor and a patient. I had asked this patient whether she’d be willing to participate in a trial. Her condition was worsening and the only treatment option I saw for her was an agent that was still in clinical development at the time. She was reluctant at first as neither she nor anyone she knew had ever participated in a study before, but eventually agreed.

“I’ll do it because I trust you want the best for me.”

The exclusion of minority groups from the research and development ecosystem is both the result of, and results in, mistrust and a delayed uptake of life-saving innovative medicines and effective care models, further heightening disparities in care and outcomes. A vicious cycle that needs to be addressed by a 360° approach. It has existed before and extends beyond the pandemic, but COVID-19 also further demonstrated long-standing, systemic racial inequities in health. The rate of hospitalization and death in minority groups was disproportionate, and minority patients were reluctant to participate in clinical trials.

Health equity is a topic that’s close to my heart and my personal purpose is to develop the best medicines that improve the standard of care for all patients. When I look across the Novartis portfolio of medicines with over 500 ongoing clinical trials across over 50 diseases, there is no population on earth that is not affected by at least one of the diseases our research efforts cover. Understanding who the patients most likely to be treated for a disease or condition are and how they will respond to a treatment is essential for our research efforts to develop transformative medicines. Cardiovascular disease, for example, is globally prevalent but disproportionally affects certain racial and age groups. It takes substantial scale to study and we need to ensure clinical trial participants represent the epidemiology of the disease.?

Understanding who the patients most likely to be treated for a disease or condition are and how they will respond to a treatment is essential for our research efforts to develop transformative medicines.

To play our part toward addressing the barriers to clinical trial participation and ultimately help eliminate health inequity in society, Novartis has published a new Commitment to Diversity in Clinical Trials . We’ve learned from what has previously happened in pockets of the organization to form a global, holistic, measurable approach.

In the short term, we are committing to first evaluating diversity and inclusion principles for all of our Phase 3 studies with US country participation, with the goal to increase and embed this evaluation throughout our global trials. In the longer term, we are working to leverage data and digital technologies, build strategic partnerships and remodel our processes and tools to create sustainable change.

We are working to leverage data and digital technologies, build strategic partnerships and remodel our processes and tools to create sustainable change.

For example in the data and digital space, we are using and expanding our existing tools by integrating our own clinical trial data with external sources of demographic and census data. Through this, we are aiming to build epidemiologic insights and set baselines and target ratios for patient enrollment in terms of gender, ethnicity and race appropriate for each trial. By embracing digital patient recruitment and decentralized clinical trials, we are further enabling diversity in patient participation across geography, socio-economic status and mobility. For instance, we’ve seen that social-media campaigns can reach a broader group of patients who could participate in our clinical studies, and that telemedicine-enabled trials can expand access to patients with lower mobility.

The lack of diversity not only exists among trial participants, but also among clinical trial investigators, medical school students, and physicians. To take action and address this, Novartis recently announced a 10-year collaboration with Coursera, the National Medical Association, Thurgood Marshall College Fund, Morehouse School of Medicine and 26 additional Historically Black Colleges, Universities and Medical Schools (HBCUs). Working together, we’re planning to co-create a platform and collectively design programs and solutions to create greater diversity, equity and inclusion across the research and development ecosystem. In the spirit of true diversity and inclusion (D&I), we are inviting others to join us on this endeavor. One of the four key areas of focus is around supporting the establishment of Digitally Enabled Clinical Trial Centers of Excellence, managed and led by clinical researchers of color, to build trust, increase diversity and inclusivity in clinical trials, and contribute to improved health outcomes for people of color.

Within the Global Drug Development organization that I lead, we recognize that D&I considerations need to be integrated into everything we do, for example core processes and existing decision points, as well as tools and solutions that empower our clinical teams to increase D&I. For instance, when we engage patients at key moments in the development and launch of a medicine, we need to ensure that this input comes from a diverse group of patients that can offer various different perspectives. However, ensuring that D&I is embedded in our research approach starts with it being embedded in our culture and is fundamental to achieving our purpose as a medicines company. At Novartis, we encourage all of our associates to embrace what makes them unique and understand and overcome their own biases in order to recognize that we all bring diverse perspectives to our work, which help us generate new ideas, drive innovation and understand our stakeholders and patients.

Eliminating health inequity in society will take time and there is no single solution to this critical challenge. It calls for a holistic approach to embedding D&I across the clinical development ecosystem and will take the concerted, urgent action of diverse stakeholders across the public and private sectors. I am passionate about ensuring every patient can achieve the best outcomes from our medicines as possible and am proud of the proactive, science-driven approach we are taking.

If you found this article interesting, please also read my personal story as an Asian American , which I shared here in March because I believe creating awareness through speaking up is critical for overcoming inequity, such as the discrimination against Asian Americans during the COVID-19 pandemic.