What Is the Future of Patient Engagement Planning?

Patient engagement planning is entering a new phase. As patient-centricity continues to shape how clinical trials are designed and executed, sponsors face a difficult question: how far should personalization go?

From counseling services to gym memberships, sponsors are exploring new ways to support participants. But at what point does added care risk influencing trial outcomes?

To unpack the balance between meaningful engagement and scientific integrity, this Xtalks Spotlight features Stephanie Galarza, Associate Director of Patient Recruitment at IQVIA. Galarza leads patient recruitment and retention efforts, aligning operational execution with strategic goals across global studies.

With more than a decade of experience across patient recruitment and trial optimization, she brings an operationally focused perspective to one of the most pressing questions in clinical operations: how to build engagement models that are inclusive, scalable and measurable without compromising data validity.

Personalization in Trials: How Much Is Too Much?

Patient support offerings are expanding. Increasingly, trials incorporate services such as registered dietitian counseling, reimbursement for gym memberships and even meal-related planning to support participants in making lifestyle changes alongside study participation.

Galarza said the intent is not to “over-personalize,” but to enable participants to actually implement what many protocols already include, particularly in obesity studies.

A key nuance, she explained, is that many obesity protocols include “vague lifestyle counseling.” The operational challenge is turning that general guidance into something participants can follow consistently enough that outcomes remain interpretable.

When lifestyle support is designed thoughtfully, she noted, it can improve overall outcomes while still allowing treatment effects to be assessed.

“What our goal is, is really one to support everyone in the same way. So have a little bit of standardization there.”

— Stephanie Galarza

“Some patients will lose weight because they’re exercising and they’ve improved their diet,” she said. “And then we expect that if the drug is working for the patients who are receiving the drug, they will lose more weight and have a more significant impact. So they’re really supposed to work hand in hand and improve the lives of patients.”

For Galarza, the key is standardization across participants and sites, with customization used to keep protocol expectations feasible across geographies and cultures.

At the same time, “customization” can be essential when protocols specify requirements such as a calorie deficit, because diet patterns vary across countries. “The diet in the US is going to be different than the UK or Japan, for example,” she said, emphasizing that support should be adapted so it is realistic for participants to follow while still aligned with protocol intent.

Her bottom line is that patient support should be intentional and strategically designed so it does not cross into influencing outcomes in a way that clouds validity.

“We aren’t providing so much personalization that the results are then not valid,” she said.

Why Select Sites if They Need Supplemental Support?

At first glance, selecting sites that require extra staffing or external services may sound counterintuitive. But Galarza framed supplemental support as a way to protect study execution in a resource-constrained environment.

“We understand that retention in studies is really important, that sites are strapped for resources,” she said. Sponsors also want access to “the best sites that have the biggest patient population,” but those sites may not always have the capacity to deliver the full level of support required.

Importantly, she emphasized that needing support is not a reflection of site skill. “So it’s not necessarily about the sites not having skills or not having patients, but reducing their burden to enable them to perform at the highest level and provide that level of care in turn to the patients.”

Galarza highlighted two common examples of supplemental support:

• Virtual registered dietitian counseling, particularly when sites do not have that resource available, or when the needed level of counseling does not justify hiring a dedicated role at a site
• Supplemental site staffing, such as a study coordinator, to reduce burden and maintain consistent execution

This approach, she explained, can allow more sites to participate, helping studies reach a wider and more representative patient population while also expediting timelines and supporting overall study quality and execution.

Planning for Long-Term Follow-Up and Retention

Long-term retention is one of the hardest operational challenges in clinical research, and Galarza called it “a really big topic.”

While study teams often treat recruitment as the urgent priority during startup, she stressed that retention needs to be designed in from the beginning. “So really planning for that retention upfront,” she said, even when “recruitment is the star of that show.”

Galarza described retention planning as a combination of:

• Selecting participants who understand the commitment and the value of staying in the study
• Training and resourcing sites so they can communicate expectations clearly and maintain frequent touchpoints
• Proactive planning that anticipates different barriers for different participants, rather than relying on a single retention tactic

“Retaining one patient may mean something and then another patient a totally different solution because the barriers to participation or continued participation are different,” she said.

Example: Retention in Obesity Trials

Galarza also pointed to a practical reality in obesity trials: many participants are working professionals who may not feel sick on a day-to-day basis. As a result, frequent visits and follow-ups may not align with their normal routines.

In these cases, retention planning may require reducing time burden and making site interactions more efficient. It can also mean equipping sites to problem-solve around participant schedules without sacrificing protocol requirements.

Example: Keeping Participants Engaged Through Major Life Changes

Another common retention risk is life transitions, such as younger adults moving for school or work.

“If something does happen, how can we mitigate that risk and keep that person participating as long as possible?” Galarza said.

She emphasized the importance of clear communication of commitment during enrollment and having transition plans to mitigate disruption if a participant’s circumstances change.

Designing Engagement That Delivers Impact Without Compromise

Patient engagement planning is evolving from “nice-to-have” to a core element of trial quality, particularly in high-enrollment, high-visibility categories like obesity.

In Galarza’s view, the future will be defined by programs that combine standardization with realistic, culturally aware execution and use supplemental support to broaden access while reducing site burden.

It will also depend on treating retention as a startup priority, not an afterthought.

The goal is measurable impact, improved participant experience and stronger trial execution, all while protecting scientific integrity.

This article was created in collaboration with the sponsoring company and the Xtalks editorial team.