The FDA has recommended clinical trial sponsors submit a Diversity Action Plan (DAP) for all Phase 3 and pivotal studies. Yet, many sponsors are uncertain about what is expected of them and how to best create a successful DAP. We hypothesized that sponsors who have had the most success developing, presenting, and engaging the FDA created and applied similar approaches and systems. Results of in-depth interviews and public and confidential source data found that there were nine common approaches successful sponsors applied with their DAPs. For sponsors who did not apply these approaches, their DAP development has been “chaotic,” “wasteful,” and demoralizing. Results support industry considering these approaches best practices and study sponsors employing these practices to improve their DAP planning, development, and outcomes.

Diversity is a key success factor in clinical trials: advancing science and medicine through a variety of lived experiences and living conditions – particularly, people with disabilities. Digital accessibility design standards for patients with disabilities can be critical to clinical trial access, engagement, adherence, and measurement. With the Web Content Accessibility Guidelines (WCAG) design standards for Information & Communication Technologies (ICT), explore the WHY, the HOW, and the WHAT for digital accessibility in clinical trial diversity. WHY: patients and types of disabilities WHAT: trends in digital health and clinical trials HOW: digital accessibility design standards

Recognize that feedback from real-world clinical experience is crucial for comparing and improving the use of drugs, vaccines, medical devices

• Acknowledge how to take advantage of the far broader options now available to trial sponsors
• Go over at length the hurdles of Social Determinants of Health (SDOH) and see why they must be understood to be solved
• Engage in a conversation about how the industry must spearhead the movement to move beyond this

There is a need to implement diversity plans and innovate for patient access for increased awareness and improved gender, racial and ethnic representation in clinical trials.

• Gain insight into adapting the draft guidance which provides a framework for a Diversity Plan focused specifically on racial and ethnic characteristics.
• Understand how to support the objectives of this new guidance by highlighting methodological implementation of the Diversity Plan.
• Discover how to put in place the opportunities for studies to facilitate their implementation and expansion.

To achieve greater diversity and inclusion in clinical trials, we must understand the history behind a major issue in disadvantaged populations: medical mistrust.

• Understand the Past and explore historic examples of medical mistreatment, particularly as they relate to clinical and scientific research
• Address the Present and recognize the remnants of past failures and give credit to advancements and progression in the proper direction
• Prepare for the Future, discuss opportunities for improvement and identify key resources for development while establishing boundaries to avoid repeating history

There is a need for a comprehensive understanding of health trends and challenges through robust data and analysis. This facilitates evidence-based decision-making, supports impactful strategies, and enables effective policy engagement. The emphasis on this session will include an overview of the need for:

• In-Depth Understanding of Health Trends: Comprehensive data collection on health issues, including disease prevalence and mortality rates, provides a clear picture of global and local health trends. This knowledge is crucial to understand the evolving health landscape.
• Evidence-Based Decision Making: The use of advanced analytical tools and health metrics allows for data-driven decision-making. This provides in aligning research and development strategies with real-world health needs.
• Collaboration and Policy Engagement: Data can serve as a common ground for Pharma companies to engage with policymakers, healthcare providers, and international bodies. This collaboration can lead to more cohesive and impactful health strategies.

For many reasons, the medical device industry faces a unique journey towards representative enrollment. During this session we will:

• Discuss challenges that Med Tech faces towards achieving representative enrollment.
• Share our experience on what's worked well... and what hasn't.
• Identify opportunities to partner across the industry to address barriers to success.

Precision medicine requires the referencing of sequencing data to arrive at a targeted therapy, however we can all agree that the genetics samples and health data utilized for the analysis has significant diversity gaps, we have a commitment to address the disparity (Lee et al 2022)

• There are several ways to define diversity in the context of precision medicine, becoming familiar with these varied approaches can advise both trial design and recruitment strategies.
• Recruitment strategies geared a improving the diversity of patient participation in precision medicine research must include mapping out the biocultural journeys of target populations. This approach can aid the development of research scientific aims that serve the population.
• Diversity in Precision Medicine should not only address diverse patient enrollments but should also address diversity patient needs and risk/benefit ratios in clinical research.