Benefits of Integrating Patient Engagement with Diversity, Equity, and Inclusion in New Medical Product Development: A Call for Action
ver the past decade, the importance of patient engagement (PE) has surged, reflecting a move towards integrating patient experiences and insights into research processes. This evolution aims not just to involve patients but to empower them as research partners. Concurrently, there’s a burgeoning urgency to incorporate diversity, equity, and inclusion (DEI) principles into the drug development process, though largely as a separate and distinct effort.
This integration is not just an ethical imperative for equitable healthcare, but a strategic move promising more personalized medicines built on stronger evidence of safety and efficacy across diverse and representative studies and an inclusive healthcare system where factors like race, ethnicity, or socioeconomic status do not dictate health outcomes.
This article explores the benefits and significance of merging PE with DEI in the development of new medical products, and practical steps that can make it a reality, with profound implications for the healthcare industry, biopharmaceutical companies, and, most importantly, patients. Lastly, we will cover a compelling trend for the PE and DEI paradigm shifts that, coupled together, speaks to a transformative change in our industry that answers the question “Why now?”
Understanding the Need for Integration
Before starting clinical development, it is invaluable to gather perspectives directly from patients who are representative of the intended condition to learn first-hand about their lived experiences. This enables a development process that is more informed about unmet needs, symptoms that matter most, the burden of the condition or current treatment, as well as the impact on people’s lives and the lives of their care partners. This increased clarity can help shape the design and conduct of more inclusive and patient-centric clinical trials. Gaining these representative and more diverse patient insights need not cause delay in the development process nor in trial recruitment. Proactively including these insights from the outset can decrease the overall development cycle time, as opposed to utilizing PE as a rescue strategy when recruitment rates are slower than anticipated.
In fact, integrating PE builds trust and inclusion among patients and the general public more broadly, which is critically important to achieving shared objectives of advancing science and patient care for those in need. The US FDA’s Patient-Focused Drug Development (PFDD) program seeks to embed patient perspectives into regulatory decisions, aiming for treatments that resonate with patient experiences.
Historically, clinical trials have lacked diversity in race, ethnicity, gender identity, socioeconomic status, age, comorbidities, and pregnant and lactating women, which has limited our understanding of benefits and risks across relevant demographics for a given medical condition. The FDA’s guidance on diversity action plans urges pharmaceutical companies to broaden trial diversity, across the various aspects of diversity. For reasons including health equity and structural determinants of health (SDOH), the FDA is focusing on racial and ethnic diversity.
Taken together, the focus on FDA’s PFDD emphasis, along with DEI initiatives, serves to foster inclusivity, cultural competence, and trust in clinical development. This approach values participant diversity, enhancing community engagement, and respect in research. By integrating PE and DEI, we accelerate impactful changes beyond mere compliance, ensuring patient- and community-centricity across all diversity aspects.
Benefits of Integration
The benefits of designing trials that people want to enroll and stay in through to the end include improved data quality, improved understanding of genetic differences, and greater support of safety and efficacy assessment in relevant subpopulations. The value of engaging patients, caregivers, and advocacy groups throughout development prioritizes relevant outcomes and enhanced product labeling which in turn supports better medical decision-making at the point of care.
Integrating patient engagement (PE) and diversity action plans—what this article calls “Equity-Centered Patient Engagement”—boosts clinical development programs by providing methodology and emerging best practices to inform the process much earlier than Phase 2. Early identification of diverse patient needs can help shape study design, including eligibility criteria, endpoints, and trial locations, focusing on underrepresented groups. This approach enables more inclusive and effective trial designs and helps build trust.
The FDA suggests that sponsors include diversity action plans in their Investigational New Drug Applications (NDAs), ideally during early development or by the End-of-Phase-2 meeting, as well as in marketing applications. These plans should detail implementation successes and challenges, promoting industry-wide learning and collaboration.
Sponsors are encouraged to discuss diverse population enrollment strategies with the FDA throughout development. The plans should prioritize early and ongoing inclusion of underrepresented groups to gather adequate safety and effectiveness data. If recruitment goals aren’t met, sponsors should anticipate planning for post-marketing data collection.
FDA also emphasizes specific enrollment and retention strategies, such as accessible site locations, community engagement, and addressing language, disability, and transportation barriers. These operational aspects are crucial for enhancing trial inclusivity and are a key focus for both the FDA and industry sponsors.
Practical Steps for Integration
Companies can take specific actions to begin integrating PE strategies and insights with diversity action plans in clinical research. Here are some practical ways to begin:
- Diverse Patient Advisory Boards: Establish patient advisory boards that reflect the diversity of the patient population. The US Census Bureau reported in 2022 that more than 40% of the US population identifies as nonwhite, which could encompass Hispanic or Latino, Blacks, Asians, Native Americans, and people of Middle Eastern descent. Advisory boards can provide insights, feedback, and recommendations for product development. Diversity and inclusion in the development process bring together individuals with varied experiences and challenges, which encourages a more holistic perspective. Diverse insights can uncover new opportunities for innovation and improvement that may have been overlooked in a less inclusive process.
- Community Partnerships: Collaborate with communities and organizations that serve diverse and underserved patient populations. Engaging local community leaders, understanding the unique needs of their community, and seeking an ongoing relationship helps build trust and facilitate participation in research and clinical trials. Engaging patients from diverse backgrounds allows for a deeper understanding of their needs and challenges and an alignment of expectations. This insight is invaluable in developing medical products that address a broader range of patient demographics relevant for a given medical condition.
- Language and Cultural Competency: Ensure that communications with patients and patient communities, written and verbal, are delivered in the languages commonly used by the patient population and incorporate well-proven health literacy principles and techniques. Each occasion to bring clarity and understanding through effective communication serves as an opportunity to build trust. Integrating patient and community engagement into the development process enables the creation of tailored solutions, for example, by anticipating the cultural, linguistic, and physical requirements of people from more diverse backgrounds, including people from racial and ethnic minority groups, people experiencing poverty, and rural communities in order to reach people where they are with a more personalized approach. The goal is to enhance satisfaction, help build trust, and ultimately lead to better health outcomes.
Leveraging PE to increase diversity in clinical research can also enhance the overall quality of clinical trials. Engaged participants in clinical trials are more likely to understand and follow instructions and requirements and can provide valuable feedback, so they are more likely to complete trials successfully. This patient-centric approach helps to ensure that patients and communities are uplifted after interactions with the clinical trial sites and team members with more positive experiences. In time, people may feel more empowered to navigate their healthcare journeys, ultimately leading to the preservation of dignity for individuals and communities.
Strengthening Environmental, Social, and Governance (ESG) Strategies
To take it even further, PE, when integrated into sustainability strategies, can offer authentic and lasting impact. This integration brings a patient-centered perspective into sustainability considerations, demonstrating the value of PE and DEI for investors, industry, patients, and society as a whole.
In the biopharmaceutical industry, patients and patient communities are recognized as a key stakeholder group. As such, their perspectives and experiences hold significant weight in environmental, social, and governance (ESG) considerations. ESG is a framework that assesses an organization’s business practices and performance in various areas, including sustainability and ethical issues.
An effective sustainability strategy should include activities that are “material” or important to a company’s core purpose. Sustainability strategies that align with an organization’s core purpose and what matters to stakeholders, often referred to as “double materiality,” can create greater value. This trend has caught the attention of both the patient and investor communities.
Companies that integrate PE strategies and DEI are likely to be seen as more responsible and ethical. This enhanced reputation can translate into greater support for research and development efforts and the fulfillment of shared objectives. Improved social impact can lead to enhanced brand identity and reputation, and can ultimately impact patient choices in terms of clinical trial participation and medication choices. Internally, companies experience improved employee morale with a greater sense of purpose and urgency in the work environment, as well as the ability to attract and retain employees.
In capital markets, some investors use ESG criteria to evaluate companies and determine their investment plans. This practice, known as ESG investing, involves considering an organization’s environmental impact, how it treats employees, suppliers, and other stakeholders, and its overall ethical and sustainable business practices and governance.
In Europe, the Corporate Sustainability Reporting Directive went into force in January 2023, requiring 50,000 companies to file annual reports on business risks and opportunities related to social and environmental issues and how their operations affect people and the environment.
A multistakeholder convening organization called Patient Focused Medicines Development (PFMD) has played a crucial role in bringing together investors, industry experts, and the patient community to explore this topic. Analysts and investors expressed their need for quantifiable measures that demonstrate an organization’s impact on both financial performance and the well-being of patients and society. Experts have shown how PE efforts align with ESG goals on issues such as reducing the number of patient visits during clinical trials sites using telehealth or home health visits, which can result in greater efficiency, enhanced patient quality of life, and improved environmental impact.
Similarly, integrating DEI principles into a company’s ESG framework can offer potential benefits. This integration improves decision-making and innovation through diverse perspectives. Like PE, a commitment to DEI enhances a company’s image as an ethical and responsible corporate citizen, aligning seamlessly with ESG principles. In the US, Bioethics International has been developing metrics for DEI in clinical trials to rate corporate performance through its Good Pharma Scorecard (GPS) publication. Pharmaceutical companies are sharing their GPS DEI ratings in their annual reports and Securities and Exchange Commission (SEC) filings to demonstrate their commitment to elevating DEI efforts.
The integration of PE and DEI principles into ESG strategies has the potential to be a potent combination. It positions businesses to lead in sustainable and equitable practices, appealing to ESG-focused investors and ensuring beneficial outcomes that align with the shared objectives of all stakeholders.
Organizations can:
- Promote sustainability and equity in their operations, products, and services
- Foster a positive reputation as responsible and ethical corporate citizens
- Demonstrate a commitment to social and environmental causes
- Align with the expectations of ethical investors and the broader public
- Contribute to improved patient outcomes and community well-being
- Drive innovation and decision-making through diverse perspectives.
Organizations that integrate PE and DEI into ESG principles may also be seen as socially responsible, culturally competent, and patient centered. A positive reputation attracts patients, investors, and ethical consumers, contributing to the organization’s long-term success.
An inclusive approach to medical product development also extends to the organization’s internal culture. When organizations value DEI, they are more likely to attract diverse talent. A diverse workforce brings fresh perspectives and ideas, enhancing innovation and decision-making. Moreover, organizations known for their inclusive practices are more likely to be the employers of choice for a wide range of professionals.
Conclusion
As the industry continues to evolve, the synergistic integration of DEI and PE can help pave the way for more “Equity-Centered Patient Engagement” and more accessible global healthcare in the future. Individually, their impact will be substantial. The fusion, however, not only advances each effort but also catalyzes a more transformative and urgently needed change in the biopharmaceutical industry, responding compellingly to the question “Why now?” and setting a new standard for patient-centered, inclusive healthcare.