Current dynamics across the oncology clinical development landscape – including extremely rapid therapeutic innovation, crowded treatment and trial pathways, highly complex trials and increasingly biomarker-segmented patient populations– are leading to significant enrollment feasibility challenges across a range of oncology drugs and trial archetypes. At the same time, the new requirements for Diversity Action Plans and commitments to improve the level of representativeness in clinical trial populations bring additional design and delivery variables into consideration. Together, there is a new level of urgency around advancing pragmatic approaches that balance multiple interests without extending the time for innovative therapeutics to reach the patients who will benefit from them. This also provides a real possibility for stakeholders to navigate the complexity in partnership with the FDA.

Key program and trial design levers – including trial inclusion/exclusion criteria, country selection, site type and number mix, and patient screening strategies – provide an opportunity to optimize diversity plans for cross-population outcomes, and many efforts are already ongoing across sites, patient organizations, sponsors, and CROs. 

The IQVIA Institute, in collaboration with the IQVIA Oncology Center of Excellence, has assembled a multi-stakeholder panel to explore the challenges, key levers, and scenarios for consideration in oncology clinical trial diversity planning processes and in designing and delivering those trials. Our panel will look to address issues such as: 

• Determining the ‘right’ level of diversity to ensure inclusive access and sub-group insights
• Balancing optimal diversity without delaying the availability of new medicines when designing trials and programs
• Adopting varied planning approaches based on trial archetype (e.g., rare vs. non-rare cancer target, level of trial complexity)
• Building effective FDA communication and partnership into diversity planning process
• Implementing clinical trial plans that deliver optimized trial inclusiveness 
• Measuring progress across a diverse pipeline of oncology trial archetypes and diversity plans