Optimizing Diversity: A Site-Level Strategy for Clinical Trials

How sites can lead the charge in improving diversity and inclusion to improve clinical trials.  

As regulatory agencies mandate clinical trial diversity action plans, trial sites play a pivotal role in meeting these requirements. In a recent Syneos Health podcast episode, experts share how oncology trial sites can adopt practical strategies to create more inclusive, representative and effective studies. 

The Role of Trial Sites in Diversity 

Ensuring that clinical trials reflect real-world populations is essential for developing treatments that benefit all patients. Sites are at the heart of this effort, with the potential to directly impact which patients are recruited and retained in studies.  

“Sites need to understand their patient population and reach out beyond their usual recruitment pools,” says Jane Bentley, Vice President of Oncology Therapeutic Strategy and Innovation. By engaging with local communities, advocacy groups and using targeted outreach methods, sites can expand their participant base and ensure that trials reflect the diversity of the disease population. 

By engaging with local communities, advocacy groups and using targeted outreach methods, sites can expand their participant base and ensure that trials reflect the diversity of the disease population.

Utilizing Technology to Expand Reach 

Sites can leverage technology to reduce the barriers that traditionally hinder diverse participation. AI tools and digital platforms help sites funnel more diverse patient populations into clinical trials. These technologies allow sites to identify patients more effectively by scanning electronic medical records (EMRs) and using AI to predict who might be eligible for trials. 

Another successful approach involves using patient concierge services, which can address transportation and scheduling challenges that disproportionately affect underrepresented groups. These services can arrange transportation, accommodate caregivers, and bring trial-related procedures directly to the patient through home nursing solutions, making participation more accessible. 

Building Cultural Competency at the Site Level 

Cultural competency is critical when working with diverse populations, and it starts with site staff. Roberts stresses the importance of making sure that patients feel understood and respected. “It’s often the small things — diverse representation in patient-facing materials, having site personnel who can relate to patients culturally, and being sensitive to language barriers — that can make a big difference,” she says. 

Involving caregivers in trial communications early on is an effective strategy. Many oncology patients rely heavily on caregivers so by ensuring caregiver involvement in the trial process can ease patient concerns and improve retention. Sites that take steps to accommodate the needs of both patients and their caregivers — whether through flexible scheduling or home-based solutions — are more likely to succeed in recruiting and retaining diverse participants. 

Collaborating with CROs and Sponsors 

While sites play a critical role, collaboration with CROs and sponsors is equally important. Patient Recruitment Liaison, Kelli Defenbaugh, notes that sponsors are increasingly looking to sites for feedback on protocol designs that might impact diversity. Sites should be vocal about the tools and support they need to implement diversity initiatives effectively, from budget considerations to operational resources like nurse navigators who can guide patients through the trial process. 

Another key area of collaboration is the feedback loop between sponsors, CROs and sites. Regular feedback mechanisms, including patient surveys, are essential for understanding what works and what doesn’t in terms of diversity initiatives. Sites that actively participate in these conversations help shape future trials and contribute to long-term improvements in trial design and patient engagement. 

Measuring and Sustaining Success 

Diversity is not a one-time initiative but an ongoing effort that requires continuous evaluation and adjustment. Sites can track success through various metrics beyond simple enrollment numbers. Retention rates, patient feedback and even the quality of informed consent processes can provide valuable insights into how well diversity goals are being met. 

“Retention is a crucial part of diversity,” Roberts explains. “It’s not just about getting diverse patients into the trial, but about ensuring they stay in the trial.” Sites can foster retention by addressing patient needs holistically, from managing side effects to providing logistical and emotional support throughout the trial journey. 

Sites also need to incorporate diversity into their long-term planning. As Bentley notes, “Diversity initiatives must become part of the site’s DNA.” This means that ongoing relationships with community organizations, long-term cultural competency training and sustained efforts to improve patient experiences are built into how sites operate. 

Diversity initiatives must become part of the site's DNA.

Looking Forward 

The road to more inclusive clinical trials requires a multi-faceted approach, with trial sites leading the charge. By addressing protocol barriers, utilizing technology, building cultural competency and fostering strong collaboration with sponsors, sites can play a crucial role in optimizing diversity in oncology trials. These efforts will not only benefit the individual patients who participate but also ensure that the findings of clinical trials are truly representative of the diverse populations affected by disease. 

Listen to the full podcast episode for more insights on site-level strategies to enhance diversity in oncology trials. 

Contributors 

 Juliette Roberts | VP, Global Head, Oncology Therapeutic Strategy & Innovation 

Jane Bentley | VP, Oncology Therapeutic Strategy & Innovation 

Kelli Defenbaugh | Patient Recruitment Liaison, Patient Recruitment and Retention Management