Managing Patient Experience and RWE in Clinical Trials: Q&A with Matt Holms, MB

In early April 2026, Pfizer and BioNTech paused a study for their COVID vaccine due to enrollment shortfalls. This came several weeks after Pfizer announced results from a Lyme disease vaccine study that missed a key cutoff goal due to fewer than anticipated cases of Lyme disease amongst the trial participants.

While the Covid vaccine study was impacted by strict guidance from FDA, both instances show how promising drugs can stumble during the trial phase due to operational issues.

Mattl Holms, MBA, is VP of commercial, patient engagement, and recruitment at Citeline. He spoke with Pharmaceutical Executive about the ways that the industry is updating the way it handles trial design to tackle these potential problems before the trials even begin.

Pharmaceutical Executive: How can pharma ensure that it is recruiting the right patients for clinical trials?
Matt Holms, MBA: Sponsors continue to execute clinical studies with increasingly more complex inclusion/exclusion (I/E) criteria. While this is driven by clinical profile needs and business drivers for post-market differentiation within a highly competitive environment, it continues to increase the complexity of patient recruitment for both sites and patients.

Feasibility has evolved where leveraging real-world data (RWD), electronic health records (EHR) integration, and AI-driven patient identification — to match patients based not only on clinical characteristics, but also on likelihood to adhere and complete the trial — is no longer a nice to have, but the norm. Equally important is early collaboration with investigators and patient advocacy groups to validate that eligibility criteria reflect real-world populations. Overly restrictive protocols often result in “ideal” patients who don’t exist at scale, delaying enrollment.

PE: What does pharma need to do to properly engage patients in clinical trials?
Holms: Patient engagement is a broad concept with many different facets of actual execution. It starts with incorporating the patient voice during protocol development to minimize burden. More specifically, how can the same clinical trial objectives be met but at the same time reduce unnecessary site visits, simplify procedures, and integrate decentralized elements where appropriate?

Clear, transparent communication is also critical. Patients need and want to understand how the trial fits into their care journey, what’s expected of them and the value of participation. Ongoing engagement tactics can include regular updates, support services, and feedback loops that will help maintain trust and retention throughout the study. Patients and sites seek more simplicity, and the patient voice is often the ideal starting point.

PE: What gaps exist in the clinical trial landscape?
Holms: One of the biggest gaps is the disconnect between trial design and real-world patient experience. This concept is not new to the industry; however, protocols are still often built around scientific rigor without equal consideration for feasibility from the patient’s perspective.

While there have been notable advances to focus on increasing diversity in enrollment and better access, many trials still fail to adequately reach underrepresented populations due to geographic, socioeconomic, and systemic barriers. Lastly, data fragmentation across healthcare systems still limits the potential ability to efficiently identify and recruit eligible patients at scale.

PE: What issues regularly lead to poor patient engagement in trials?
Holms: The most common issues are excessive patient burden and logistical challenges that interfere with daily life. Common challenges include burdensome protocols focusing on complicated eligibility requirements, too many site visits, complex procedures and inadequate communication about the purpose and process of the trial. Patients who don’t feel informed or supported are less likely to remain engaged. When participation feels disruptive and patients feel overwhelmed, unsupported, or are unclear on expectations, dropout becomes much more likely.

Sites are the unsung heroes in clinical research, but site burden due to resource constraints is a legitimate challenge with patient engagement. Some sponsors invest in patient engagement resources, technology and tools, but it’s not always part of the overall clinical trial investment. Reasons for this include prioritization of resources for patient recruitment and perception that generalized patient engagement tools are more difficult to trace back specifically to measure return on investment (ROI). Sites could greatly benefit from sponsors investing in more patient engagement tools and resources.

PE: What are the most common clinical trial missteps?
Holms: Several recurring missteps continue to limit the success of clinical trials, many of which are preventable with more patient-centered planning. First, overly complex protocol design remains one of the biggest challenges. Trials are often built to maximize data collection, but this inadvertently increases patient burden, narrows eligibility, and creates friction for sites. This can significantly slow recruitment and increase dropout rates.

Second, there is still a tendency to treat recruitment and retention as downstream execution issues rather than strategic priorities. When patient engagement is not embedded early in trial design, sponsors often find themselves reacting to enrollment shortfalls instead of proactively mitigating them. Another common misstep is insufficient incorporation of real-world insight. Trials frequently lack input from patients, caregivers and frontline investigators during the design phase, leading to protocols that may be scientifically sound but operationally difficult to execute. Operational fragmentation is also a persistent issue whereby disconnected systems, inconsistent site performance and lack of coordination across stakeholders can create a disjointed experience for patients and sites.

Ultimately, a common root cause is designing trials around internal assumptions rather than the realities of patient and site experience. Sponsors that prioritize simplicity and early patient/site stakeholder engagement are better positioned to execute successfully.