Beyond Recruitment: Q&A with Del Smith, PhD, Acclinate

The clinical research industry has long acknowledged the gap between intention and action on trial diversity, but the path from awareness to meaningful representation remains poorly mapped for many sponsors.

To explore this further, Applied Clinical Trials spoke with Del Smith, PhD, CEO and co-founder of Acclinate, about what distinguishes authentic community engagement from transactional recruitment outreach, why sustained engagement carries measurable ROI, and how the insights gathered through genuine community relationships can reshape everything from protocol design to site selection.

ACT: What are the most common barriers that prevent underrepresented communities from participating in clinical trials, and how should research teams be addressing them?

Smith: If you look at the barriers keeping a lot of underrepresented groups from participating in clinical trials, you'll find that they fall into one or two categories. They're either structural barriers or relational barriers.

By structural barriers, I mean things like where your sites are located, what time you're expecting people to take part in your study throughout the day, whether that interferes with their work, the distance someone must travel, even compensation for taking part. Those are structural types of barriers and issues to address.

Then you also have the relational barriers. Are you engaging with the right people? Are you doing that in a sustained way? Have you built a level of trust with the individual before just coming in and asking them to be part of a study? Those are relational issues. And the thing I'll add to that, which is really important, is cultural relevance and understanding lived experiences. These are relational things that we sometimes see sponsors miss.

ACT: How does authentic community engagement differ from traditional recruitment outreach, and why does that distinction matter for trial feasibility?

Smith: Authentic community engagement is really about sustained engagement that truly understands the lived experience of the individual you are trying to engage with. That is very different from traditional approaches that come in just in time, right before a study is recruiting, and then as soon as the study is over and the sponsor has their data, they leave. That's not what we call authentic community engagement.

The other part of this is the lived experience piece. Lived experience is truly understanding, recognizing, and then making modifications to the way you engage with the community based on meeting them where they are. That could be from a proximity standpoint—you are actually meeting them at a senior citizen center or at a little league baseball game, versus trying to get someone to come to an academic medical center or a health fair that may be 15 to 20 miles from where they actually live. That's really, really important when it comes to authentic community engagement.

ACT: What does a practical trust-building framework look like for sponsors trying to improve representation across therapeutic areas?

Smith: In order for a trust-building framework to be practical, it needs to have some tangible ROI to it. The important part of that is that sponsors need to understand that you can actually get ROI from sustained community engagement, and that ROI can translate to more efficient, faster, and more representative enrollment.

The way you do that is by practicing sustained community engagement in ways where you're not just thinking about that engagement around a particular study and a particular timeline. You're thinking about how you do this work sustained over a particular indication or therapeutic area. Maybe you're very specific about the geographic areas you want to focus on, because those are around the sites you're most likely to use.

When you have that sustained engagement activity going on and tie it to your recruitment, what you typically find is that you've built a well of people who are willing and ready to take part in your studies. And that just makes the whole process much more efficient.

ACT: How can deeper community engagement translate into long-term research insights beyond just hitting enrollment targets?

Smith: A lot of people think about community engagement only in terms of mobilization, but there's a lot of additional value that comes from it. Gathering data to understand an individual's lived experience can be very helpful when it comes to protocol design, ensuring that you have the proper endpoints for your particular study, all the way to where you're locating your sites and how far someone's willing to drive.

In addition to that, you have the opportunity to build a bridge to your future studies. Instead of starting this whole process over again when your next study starts, you have an on-ramp to a much faster ability to engage and recruit. What you'll find is that sustained engagement over time has an exponential impact on your future studies.