A roadmap to budgeting for diverse recruitment

by Lauren Vamos, Operations Associate at Power

Improving clinical trial diversity starts at the community level.

Sites and sponsors are spending more time in the community than before, but there is still a minimal understanding and no validated frameworks on how to use community engagement practices effectively.

Community engagement is difficult without an explicit budget because an upfront financial investment is required to change defined processes. Without an upfront investment, diverse recruitment-specific activities fall to existing coordinators, researchers, and recruiters on top of their other daily tasks.

Since it's easier to reach existing patient populations, there's little incentive to explore alternative channels for recruitment unless there's external pressure. Although stakeholders recognize the importance of diverse recruitment, it can be challenging to prioritize diversity-specific activities within their current budgets.

Figure 1: Amalgamated “agree” and “strongly agree” responses to 2 prompts concerning diversity in research.

One tool to begin combating current roadblocks in diverse recruitment is to create a long-term plan, or roadmap, to invest in diversity. Community engagement and other diverse representation-focused initiatives that are funded with short timelines don’t foster long-term trust or relationships with the community for future research. An upfront investment is necessary to build the foundational systems that will carry forward.

This investment is necessary at the sponsor, CRO, and site levels. Each player must manage total recruitment budgets to improve their own practice while incentivizing those around them. The first tangible step is to set aside a portion of the recruiting budget at every level of research for diverse recruitment-specific activities.

The industry should expect a cost to accompany activities that are in pursuit of representativeness. Researchers and sponsors care about recruiting a representative research population, but without explicitly designated funds, sites are stuck trying to do more with the same budget.

One of the reasons it can be difficult to reallocate budgets for diverse recruitment is because quantifying ROI of investments in diverse enrollment activities is not straight forward. Lots has been said about the utility of community engagement to recruit diverse populations, but there is little validated evidence that these methods work, perhaps due to the short-term nature of many such projects.

Stakeholders could take the first step by prioritizing recruitment channels with a high potential for representative patient populations. For example, sponsors could collect data on the demographics of participants recruited from different recruitment vendors and use this information as a key deciding factor when choosing vendors for trials. If sponsors lead with the expectation that this data should be available during the selection process, it will make it easier for smaller sites and CROs to request the same data when they are expected to choose and use their own recruitment vendors.

The co-chair of the Health Equity Steering Committee at a large AMC explained that his site has a defined DEI budget set aside for diverse enrollment activities. These activities have been anecdotally invaluable to the success of diverse enrollment at the AMC for the last 20 years. One crucial element of this sample diversity and inclusion budget is salaries for community engagement coordinators.

One Principal Investigator at an industry trial site shared how they budget for a dedicated community engagement coordinator. The goal of this role is to maintain a consistent presence between recruitment sessions instead of exclusively arriving when the site needs to recruit participants. Their day-to-day job involved outreach at churches, community centers, grocery stores, schools, and assisted living facilities. The PI specified that if it is not possible to invest in an engagement coordinator, PIs and coordinators could perform these tasks themselves.

The first step of a sample diversity budget is a segment set aside for this dedicated community engagement coordinator role. Large sponsors may choose to work with sites that already have this role, or they may choose to set aside budget, especially for community engagement activities. Smaller sites that are unable to hire a full-time position may choose to budget the hourly work of a trial or outreach coordinator for engagement-specific activities.

Sponsors should highlight and incentivize innovative methods to improve diverse participation. They can choose to collect stories from their sites about the best moments in recruitment and share them with other sites or provide additional compensation for the most creative and effective ideas.

Some innovative ideas include “lunch and learn” programs. These programs invite community members to the site once a month to learn about their disease, meet others with similar conditions, and learn about all the trial options available in the area. Sites have anecdotally been successful at recruiting trial participants from the community as a result of this initiative.

The recruitment manager at a large AMC also told us that he found great success walking around an arts festival with a Bluetooth speaker wearing a sandwich board saying “ask me about clinical trials”.

Innovative initiatives like these improve participant and site staff satisfaction with the recruitment process while enhancing community engagement and resulting recruitment metrics.

Sponsors and academic medical centers are starting to see the value of patient boards. These boards are composed of community representatives that are involved in crucial elements of the iterative process in trial design and recruitment protocols. They have been effective at providing feedback on inclusion and exclusion criteria, methods design, and recruiting images and other materials that are more effective at incentivizing diverse patients to participate.

Sponsors and medical centers generally pay each board member a defined sum per meeting, and these meetings occur monthly, biweekly, or at another frequency defined by the stage in trial planning. Specific compensation can range and can depend on board member feedback and the trial budget. Patient board compensation is a comparatively small investment that can pay back in dividends if the sponsor implements feedback to improve trial accessibility and outreach.

The fact that diverse recruitment is a nascent discipline means that early investments in new types of initiatives may have an uncertain ROI. The industry has not yet invested enough in these initiatives for practitioners to have a strong sense of how any given initiative will or won't translate into patient diversity. New types of initiatives are required for diverse enrollment, so sites and sponsors must reassess budgets to enable these new activities.

Not all activities will work for all disease types in all areas. The purpose of investment now is to build a body of data on which methods are the most economically efficient, which factors most influence where and how different methods work, and ways to better predict the best methods in the future. Once defined systems exist, diverse recruitment can become the norm without any additional financial input.

This work is part of a larger body of research on diverse representation from every angle. Read the full report here.