To achieve concrete outcomes, health care organizations and the biopharma industry must establish internal protocols for identifying and addressing the underlying causes of health disparities. Patient advocates and healthcare professionals from underrepresented communities can play a critical role in removing barriers to care.
- Examine the social determinants of health for patients with various chronic diseases
- Grasp how social determinants contribute to health inequities
- Best practices to address unconscious bias
Examine the challenges faced by racial and ethnic minorities in participating in clinical trials and gain actionable strategies for addressing these barriers.
- Highlight the importance of culturally competent care and recruiting practices
- Best practices from research groups and studies that were successful in including a diverse population
- Address socio-economic factors, and the role of community outreach and engagement in fostering inclusion
Explore strategies for increasing the participation of underrepresented communities in clinical research, including targeted outreach and education efforts, as well as changes to study design and inclusion criteria.
- Best practices for engaging with communities
- Address systemic barriers that prevent underrepresented groups from participating in clinical trials
- Consider the role of community-based organizations, patient advocacy groups, and other stakeholders in promoting clinical trial diversity
There are barriers to diversity in clinical trials that you may not see. Trial criteria can themselves constrain eligibility; in black patients, comorbidities such as hypertension, diabetes, and chronic kidney disease are common, yet they are the major excluding comorbidities embedded in trial protocols. In order for outcomes to be more diverse and inclusive, the necessary infrastructure needs to be implemented in the trial design.
- Examine eligibility criteria and the barriers to access
- Pinpoint eligibility criteria discrepancies that impact different groups
- Avoid writing protocols that impact eligibility
- Evolve inclusion/exclusion criteria and increase chances for diverse patients to pass screenings
A community-centric approach is crucial for building trust – and this means specifying the ideal partners and planning out how to get the most from these relationships. Leveraging partnerships between community, academia, government, and industry represents a tremendous opportunity to cultivate and sustain diversity.
- Establish partnerships to foster trust, and build scalable and sustainable relationships and solutions
- Determine how patient groups, hospitals, medical education systems, and patient advocacy groups can serve as a direct plug into your patient population
- Review tactics to build community engagement and partnership to increase study enrollment
Healthcare and medical inequities impacting underrepresented demographics add up to a staggering $1-2 trillion in economic losses. From a moral and scientific perspective, designing more diverse and inclusive clinical trials is an increasingly prominent goal and a regulatory requirement for the biopharma industry – and how can you turn that vision into reality?
- Examine strategies to engage and communicate with the patient community to achieve results
- Recognize why the patient’s voice should be incorporated into clinical study development
- Work with sites to ensure diverse and inclusive enrollment
- Identify and engage diverse sites or locations in underserved communities
- Meet patients where they are
Explore the use of decentralized clinical trials as a means of increasing diversity in clinical trial populations and improving the representation of underrepresented groups. Discuss the benefits and challenges of decentralized trials and review strategies for ensuring the inclusion of diverse patient populations.
- Examine the role of decentralized trials in improving clinical trial diversity
- Strategies for increasing inclusion of diverse patient populations in decentralized trials
- Explore the benefits and challenges of decentralized trials for diverse patient populations
- Review the importance of maintaining patient safety and quality in decentralized trials
Examine the current state of diversity metrics in clinical trials and discuss best practices for standardizing these metrics across different studies and research settings.
- Discuss the importance of creating a common set of diversity metrics
- Discover how to track progress, identify areas where more work is needed, and take data-driven approaches
Learn how Real-World Evidence (RWE) can improve study enrollment and increase diversity in clinical research. Understand the benefits of using RWE to identify trial locations with higher diversity and more clinically meaningful results.
- Assess the potential of RWE to reduce racial disparities in clinical trials and inform trial design
- Identify diseases where diversity is particularly important
- Leverage real-world data to expand understanding of diverse populations beyond product approval
More than 70% of clinical trials fail to achieve their intended patient enrollment goals, and health literacy is a major cause. With lower health literacy in underrepresented and underserved communities, it is imperative that trial materials are understandable, linguistically, and culturally appropriate in more diverse recruitment and long-term engagement and adherence to medications or use of medical devices.
- Examine incorporating health literacy practices into clinical trials
- Review health literacy as a change agent to improve enrollment
- Recognize the importance of linguistically and culturally appropriate materials in all research communication
Clinical studies often face challenges in recruiting diverse patients, one way to overcome this is by forming strategic partnerships with advocacy groups. This can not only increase the visibility of trials to these patients but also address issues of mistrust and promote diversity and inclusion in clinical research.
- Develop a comprehensive approach to patient, industry, and community alliances
- Align with business and commercial strategy
- Incorporate patient perspective through feedback from advocacy groups
- Establish realistic expectations to establish trust and long-term relationships
Under-representation the clinical research workforce contributes to the under-representation of diverse clinical trial participants. Taking action to increase and diversify the clinical research workforce is crucial to grow and diversify the clinical research workforce for sites. Discover initiatives that aim to introduce clinical research to early education and rising talent
- Prepare students to relevant careers that sets them on a path to gain position at sites
- Outline diverse opportunities to non-traditional recruits
- Hear about programs aiming to promote 1 million black individuals without four-year degrees into family-sustaining careers
Black women face significant disparities in breast cancer outcomes. With a mortality rate 42% higher than other groups, and a 2.3 times higher rate of triple-negative breast cancer diagnosis, these disparities demand urgent attention and addressing the low level of participation of Black women in clinical trials. Providing more targeted messaging and outreach can empower and better support Black women to take an active role in breast cancer care and improve outcomes.
- Hear directly from a triple-negative breast cancer survivor
- Learn unique methods for engaging and collaborating with patients, survivors, advocates, and companies
- Discover why clinical trial participation will help Black women beat cancer
Despite efforts to increase primary healthcare access, disparities still persist and result in unequal treatment outcomes and survivorship. These are attributed to factors including social determinants of health, genetics, and lack of education and access to quality healthcare; and a lack of research that reflects the diversity and minority involvement in drug development exacerbates the issue. Identify and address the causes of healthcare disparities, increase participation of minorities in screening and research
- Develop a trust-based system on community efforts and medical/pharmaceutical leaders
- Understand individual and cultural vulnerabilities to optimize cancer prevention, diagnosis, and treatment
- The importance of considering ancestry within the African continent and the US; highlighting the role that scientists can play
Clinical trials hold the potential to make a significant impact on the health of diverse populations, but their success depends on the participation of a representative sample. Delve into the challenges that hinder clinical trial diversity and offer strategies for overcoming them. Discover the importance of addressing the accessibility challenges that prevent diverse populations from participating in clinical trials, including site locations and language barriers.
- Review efforts made to increase diversity, including the patient advocacy involvement
- Recognize the importance of communicating clearly about informed consent
- Examine past industry mistakes, such as tokenism, and the need to focus beyond race and ethnicity
People of different age, race, ethnicity, and gender do not react to medications in the same way – yet, roughly 20% of major clinical trial participants are minorities. Engaging with diverse groups of patients early in the design and development process can build trust, enhance their experience, increase participation and retention rates, and ensure that the drugs that are developed are safe and effective.
- Demonstrate the clinical and scientific importance of diversity in early clinical development
- Identify ways in which patient groups can support drug development by recruiting diverse patients
- Outline broader eligibility criteria early in the drug development process
- Explore how a patient-centered approach should emphasize diversity
