Around the Globe

Practice Follows Principles: Creating More Inclusive Patient-Centered Development & Commercialization
Hilary Wilson
Boehringer Ingelheim
Cleonette D. Cudjoe
Patient Advocate
Jen Horonjeff
Savvy Cooperative

nderrepresentation of Black and Indigenous people of color (BIPOC) and other racial and ethnic minorities in clinical trials is a longstanding issue. The disparate impact that COVID-19 has had on BIPOC, Hispanic, Latinx, and Asian communities, combined with the underrepresentation of these subgroups in some COVID-19 clinical trials, has brought a sense of urgency to address this historic challenge. Within the past year, the Pharmaceutical Manufacturers of America (PhRMA) released the first industry-wide principles on clinical trial diversity; the Multi-Regional Clinical Trials Center published the “Achieving Diversity, Inclusion, and Equity in Clinical Research” guidance; and the US FDA released a final guidance to encourage the inclusion of groups that are often overlooked in clinical trials.

Industry will not be able to address underrepresentation of racial and ethnic minorities in clinical trials if the approach is a reactive scramble each time a trial launches. Instead, inclusive design should be built into the entire process. Inclusion is a core principle of patient-centric drug development and requires directly engaging with patients to co-create solutions that address unmet patient needs. It is paramount to ensure that diverse patients are included in this process, otherwise one risks innovating only for a subset of the population and exacerbating health disparities.

The Challenge: Creating More Inclusive Drug Development Process

How do we ensure that the patient voice that informs the design of trials, products, and services is representative of the diverse gender, age, cultural, racial, and ethnic backgrounds of patients impacted by the disease? And how do we ensure that diversity and inclusion across the continuum of clinical development is not just a byline, but results in meaningful change that informs decisions at the team, company, and industry levels?

Creating Solutions: Industry and Patient Collaboration

These recommendations from a patient engagement collaboration between Boehringer Ingelheim (BI) and Savvy Cooperative, a patient-owned innovation co-op, are designed to generate solutions to this challenge and address the following organizational objectives:

  1. Create awareness about the challenges BIPOC, Latinx, and Hispanic patients experience in the healthcare ecosystem.
  2. Generate ideas and solutions to continue to advance diversity and inclusion across the continuum of clinical development.

Approach: Gathering Diverse Insights, Raising Awareness, and Co-Creating Solutions

A three-phased approach was designed to first gather insights from BIPOC, Hispanic, and Latinx patients about their experiences and perspectives on clinical trials, then amplify these insights broadly across the organization, to establish an approach for ongoing bidirectional engagement with diverse patients to further advance diversity across the clinical trial continuum (Figure 1).
chart of the Patient-Centered Approach
Figure 1. The 3-phased approach: Listen, amplify, engage.
Graphic provided by Boehringer Ingelheim.

Recommendation: Listen and Learn

Nothing more effectively builds empathy than hearing individuals share their personal stories. One of the goals of the collaboration was to foster understanding of the unique experiences and perspectives of BIPOC, Hispanic, and Latinx patients related to clinical trials across the organization. The stories shared were raw, unedited, and difficult to hear, yet critically important for the organization to understand.

There is a human tendency to jump directly to solution-oriented thinking. In truth, there is no easy fix to address intergenerational trauma endured by many communities of color. The first step is simply to listen.

“My grandfather told us about how they were allowed to go to the dentist. When you needed a tooth pulled you went to the veterinarian after midnight on a Sunday because people didn’t even want their animals to have the same medical care as black people.”

“My tribe was recently invited to be a part of a clinical trial for a COVID vaccine but too many people were concerned about safety and questions weren’t being answered so the tribe decided not to participate.”

Recommendation: Building Trust

Workshop participants ranked increasing trust as a high priority to improve diversity in clinical trials. But the workshop went deeper to uncover actionable steps to building trust, such as establishing relationships with communities, including equitably valuing diverse patient input in the development of products and services, reducing the study burden, increasing education and outreach, and doubling down on transparency surrounding these efforts.

“I also think generally providing more information about how drugs are developed, how much it costs, what the timelines are and why could help – not just providing information when a trial has been successful or a new drug is being launched. It will help the patient community to understand why it might take a long time to develop drugs, why a drug might cost so much, why a drug works the way it does. Then people aren’t left making assumptions – they have the facts and they’re more educated about the whole process.”

Recommendation: Build Relationships with Communities

Mistrust in the pharmaceutical industry runs deep. Mending this requires establishing relationships with trusted community and patient organizations in a manner that meets minority patients where they are, and recognizes and seeks to rectify the implicit power dynamics and systemic racism that got us to where we are.

This may require thinking beyond well-established national organizations, to working with grassroots and local community-based groups in order to be inclusive of those not traditionally represented by large organizations. Dialogue with diverse patients should start early on in order to identify unmet needs and provide ample opportunities to work together.

“I think pharmaceuticals companies need to have better outreach in the communities they are attempting to reach. Don’t just attempt to sell us a drug but actually try to understand how a particular disease impacts the person and their families.”

Recommendation: Co-Design Solutions

All too often, solutions to address the needs of a specific group of people are designed without any input from the target population. While well-intended, these kinds of approaches are the antithesis of a patient-centric approach.

Workshop participants were asked about the importance of including diverse patient perspectives in the design of a clinical trial, and 100% indicated this is important. 80% said that knowing diverse patients informed the design of a trial would impact their decision to participate. Co-designing solutions across the clinical trial continuum with diverse, representative patients will help ensure that the needs and preferences of all patient communities are considered.

“What better way to reach diverse patient groups then by having someone from that community assist in designing the planning – they will know what works and what best ways to recruit and put people at ease. This would have a tremendous impact on my decision to participate. For one thing I probably wouldn’t feel as much like the guinea pig. It would demonstrate a more sincere interest in understanding the disease and its impact on many populations of people.”

Being mindful of power dynamics is critical. It is imperative to work with expert moderators trained in qualitative research and implicit bias in order to create opportunities for marginalized communities to provide input in safe and effective ways. This is why it is important for industry to work with patient groups to create and facilitate their diversity and inclusion, patient council, and related initiatives, to co-create solutions across the clinical trial continuum.

Early, Often, and Throughout

Consistent with the principles of a patient-centric approach to medical product development, diverse patient perspectives must be integrated early, often and throughout the life cycle of medicines – from the design phase through to commercialization. As industry continues to advance systems and processes to support a patient-centric approach to drug development, it is critical to re-evaluate established approaches to engaging with patients to ensure that the perspectives of BIPOC patients are equitably included and integrated.

Acknowledgements: The authors would like to thank the Savvy Cooperative participants in the workshop and panel for their courage and willingness to share their perspectives, and the BI planning committee, including Nicole Cohen, Nicole Forman and Lakisha Rodwell.