The importance of diversity and equity in clinical trials 

The “Global Impact in Health” Symposium in Leiden brings together the life science community to think through ways of improving some of our most critical health dilemmas globally, including diversity and health equity. Anne Kerber, Senior VP and Head of Cell Therapy Development at Bristol Myers Squibb, gave a keynote about the importance of equity and diversity in clinical trials to deliver better science and outcomes for patients.

We are seeing a fundamental shift in the healthcare sector to tackle the societal inequalities there are to disease prevention and healthcare provision, and the need to shift towards an equity-driven approach. But what is health equity? Health equity is achieved when every person has the opportunity to “attain his or her full health potential” and no one is “disadvantaged from achieving this potential because of social position or other socially determined circumstances”. If we do not increase equity and diversity in clinical trials, the medicines that we develop will only work for a proportion of the actual population.

Did you know?

Research has been largely focused on how health conditions affect men. As a result, women are more likely to be misdiagnosed, even today*. For example, what are known as the classic symptoms for heart attacks, like pain in the chest and down the left arm, are only ‘classic’ for men. Women are more likely to experience breathlessness, fatigue, nausea and what feels like indigestion. We see the same thing in engineering. It’s shown that women are more likely to be severely injured or suffer fatal consequences when involved in car accidents because seatbelt technology is designed and tested on the male body.

Looking at ethnicity, rather than gender. As with so many aspects of this pandemic, the COVID-19 pandemic confirmed the ways in which our healthcare system isn’t built equitably as 80% of COVID-19 vaccine trial participants were white, while only 10.6% were Black and 11.6% were Hispanic/Latino.

How we increase equity and diversity in clinical trials

In 2020, BMS announced a series of global commitments over five years to accelerate and expand health equity and diversity and inclusion efforts. One of those commitments is to increase clinical trial diversity.

A lack of diversity in clinical trials is a barrier to ensuring that patient populations are accurately represented when developing new medicines. Hence, our objective is to improve the recruitment of diverse patients in our clinical trials, ensuring the trial population is more reflective of the real-world population we serve in each country and in alignment with the epidemiology of the disease we are studying.

To support this effort:

        -    We have increased the number of US sites in highly diverse areas to increase access to clinical trials, address issues related to trust, raise awareness, and educating both internally and externally and actively ensure patient representation in our clinical trial design processes.

        -    We are supporting grant writing efforts for STEM education and independent research, investing in diversity owned businesses, and increasing diverse representation in our executive roles.

        -    We also work with patient advocacy and community outreach organisations to ensure the patient voice is included in trial designs, so we understand and represent their needs.

        -    We will open clinical trials in communities that are traditionally under-served and under-represented.

        -    We are taking a customised, comprehensive approach by centring our strategy around the patient experience — from screening and early diagnosis, to access to quality care and innovative medicines.

Successful initiatives inspire future actions

At BMS, we have had some successful initiatives that have proven the effect breaking the barriers can have on trial diversity globally. For example, in the U.S. we drove increased enrolment of black patients in prostate cancer trials. This was important because globally the incidence of prostate cancer is about 60% higher for black patients than it is for white patients for unknown reasons. Despite this, black patient enrolment in prostate cancer clinical trials in the U.S. was only 4%.

In Argentina, most clinical trials take place in the private health sector, but the majority of the population is treated at public hospitals. To address this imbalance, BMS is proactively working with stakeholders across the system to increase the number of company clinical trials in the public sector.

And in Australia, we have strategies to address specific health inequity through participation in Reconciliation Action Plan (RAP) set up by the government, investment in clinical trials for rare cancers which disproportionately affect patients in regional and remote communities, and in telemedicine.

Breaking down the barriers for clinical trial participation

We’re confident that by breaking down the barriers to clinical trial participation with thoughtful and long-term approaches, we will effect real and sustainable change with maximum impact— delivering better science and outcomes for our patients. But we are also very conscious that there is much work to be done, and that our partners are critical to this journey.

This is a recap of the keynote speech given by Anne Kerber, Senior VP and Head of Cell Therapy Development at Bristol Myers Squibb, on the “Global Impact in Health” Symposium in Leiden on the 30th of May 2022.

* ‘Invisible Women – Exposing Data Bias in a World Designed by Men’ by Caroline Criado Perez