onversations about including diverse populations in clinical trials have been ongoing for decades. It has been well established that trial representation should reflect the population of those affected with the disease or condition.

With guidances and DAP requirements, clinical trial partner groups (sponsors, CROs, sites, and other vendors) continue to face unique barriers within their organization as well as interrelated barriers across partner groups. A fundamental understanding of the roles and expectations of each partner is essential as new regulatory requirements unfold and company processes change. Lack of clarity and misinterpretation of roles, responsibilities, and expectations of each partner can lead to communication gaps, mistrust, and confusion.

Effective collaboration requires good communication and mutual understanding of roles and responsibilities. The recently updated FDA draft guidance encourages sponsors to engage patients and HCPs during development of DAPs. However, it is not common practice for sponsors to ask sites for input on DAPs even though sites are responsible for enrollment and retention of research participants. While it is not feasible for sponsors to engage all sites when planning or writing DAPs, receiving feedback from some sites is critical. More transparency between partners including understanding of operational expectations, workflows, and handoffs throughout DAP implementation may ease anxieties, contribute to strong productive working relationships, and improve collaboration.

The flow of information across clinical trial partner groups is necessary for efficient study execution. When writing DAPs, sponsors estimate the number of participants needed in a trial based on disease prevalence and incidence data, then determine the number of sites needed to reach enrollment. For site selection, sponsors distribute feasibility questionnaires to determine site capability and capacity. However, site feasibility responses may generate underestimates or overestimates, or projected enrollment numbers per subgroup may not reflect the surrounding community demographics. Also, sites may not know if a sponsor will provide necessary financial resources to support enrollment efforts. Sites may fear potential repercussions, such as not being selected for future studies, in the event of underperformance even if enrollment estimates were correct at the time of completing the feasibility assessment. This example illustrates some of the mistrust among clinical trial partners. Mutual trust may be improved with better understanding of each partner’s processes, incoming competing trials, and other limitations.

A conversation about mistrust would be incomplete without mentioning ongoing patient and community mistrust of both healthcare systems and the clinical trial enterprise. Patient recruitment requires both patient and community engagement. Collaborating with community leaders and organizations as equal collaborative partners is key to achieving representative trials. Sponsors must understand the needs of the community and what research topics are of interest before asking community leaders to help with DAP implementation. Building trust requires meaningful, sustained community engagement and investment throughout drug development.

Some people question whether sponsors are submitting plans only as a box check, leaving the responsibility and accountability for successful implementation to sites. It’s one thing to write a plan but it is quite another to adhere to, monitor, measure, and evaluate the effectiveness of the plan. For example, sites often develop a site-specific recruitment plan, but it is unclear how revisions to a sponsor DAP are communicated back to these sites. Sponsors can also consider and incorporate existing site workflows, which allows sites to control some study activities (e.g., local labs, drug shipments, etc.) based on what works best for them. True collaborative efforts ensure that accountability and responsibility is shared across all clinical trial partners.

As the regulatory landscape on this topic continues to evolve, being aware of and actively identifying solutions to collaboration barriers is vital for overall success. It is important for all clinical trial partners to think creatively, be willing to have uncomfortable conversations, and remain open to change.