As we enter 2026, the conversation around clinical research has gravitated toward “trending” innovations: AI-driven data science, cutting-edge digital health tools, and revolutionary therapeutics. However, these advancements are only as effective as the infrastructure that delivers them and the success of clinical trials still depends on the ability of clinical trial sites to translate complex study designs into real-world execution.
Increasingly, sites are being asked to do more. Clinical research is no longer just about executing a protocol; it now requires sites to reach broader patient populations, generate real-world insights, and sustain long-term patient engagement. Yet, while industry expectations for site performance continue to rise, the “hidden” burden these demands place on already-stretched healthcare teams is often overlooked. Supporting sites, particularly those embedded in local communities, is no longer an optional line item; it is foundational to the future of research.
The Regulatory Push: Why Representation is Non-Negotiable
We often talk about the importance of Real-World Data (RWD) but rarely discuss the structural strain it places on site staff. 2026 marks the point where RWD moves from a regulatory ambition to a scientific requirement and a shift amplified by the December 2025 FDA Guidance, Enhancing Participation in Clinical Trials.1
This guidance requires sponsors and sites to look beyond basic enrollment metrics and intentionally include both demographic characteristics (such as race, ethnicity, age, and sex) and non-demographic characteristics (including organ dysfunction, disabilities, and geographic location). While this is a vital step for patient equity, it places significant, and often unacknowledged, burden on the sites responsible for execution.
The Numbers Behind The Requirement
The push for broader representation reflects a longstanding reality: for decades, clinical trials have failed to reflect the actual patients who will use the approved drugs.2 In the United States, Black or African American individuals make up roughly 13% of the population3 and Hispanic or Latino individuals roughly 19%,4 their representation in pivotal clinical trials often lingers in the single digits—frequently as low as 5% to 9% for many oncology and cardiovascular studies.3,5
When the FDA puts forward an expectation that patients with comorbidities or those living in “pharmacy deserts” are included in clinical research, they are essentially asking sites to rethink, and often rewrite, their standard operating procedures. Community-based sites are the key to reaching these broader patient population pools. These sites hold the trusted relationships with underrepresented groups, yet they remain underutilized.
The Paradox Of Choice For Community Sites
Many community clinics face a difficult reality: they are either already stretched to capacity or relatively inexperienced in clinical research.6 They often have access to the right patients but lack the administrative infrastructure required to manage complex trial protocols alongside their routine clinical care.
When a protocol requires rigorous RWD collection, which often involves specialized data entry, long-term monitoring, or additional examinations, a community site is forced into a difficult choice. They either decline the trial because they don’t have the specialized staffing, or they take it on and risk bed-blocking, staff burnout, or compromised care delivery.
This is why the conversation must shift from simply expecting representation to actively enabling it. If sites are expected to enroll patients with chronic kidney disease or patients who require caregiver support, sponsors must also provide the logistical infrastructure to make that possible. This can include in-home healthcare professionals (HCPs), additional support staff or decentralized data tools, all of which, when seamlessly implement, can take the weight off the site’s shoulders. Without this support, the FDA’s new guidance remains a well-intentioned goal that many community sites simply lack the capacity to meet.
From Expectation To Enablement: The Power of Site Support
This is where community-based site networks, paired with hybrid decentralized solutions, offer a scalable and sustainable path forward. Sites are individually assessed and provided targeted support based on their specific needs and capabilities. This support may include:
- Tailored & specialized site staff training: Training programs can empower site teams in areas such as real-world data collection, SDOH documentation, decentralized workflow coordination, and the use of digital trial technologies. Training can be adapted to a site’s experience level – helping trial-naïve sites become research-ready while enabling experienced sites to manage increasing protocol complexity.
- Additional site staff placement: Placement of additional site staff, either temporarily or for the duration of a study, can significantly reduce operational strain. Embedded research coordinators, data specialists, or research-experienced HCPs allow sites to scale participation without committing to permanent headcount increases.
- Home Trial Support (HTS) as an extension of the site: When combined with community-based site networks, tools such as Home Trial Support (HTS) act as a force multiplier. Routine or follow-up visits can be conducted in the patient’s home, while complex assessments remain site-based. This hybrid approach enables sites to meet inclusion goals for patients with mobility challenges, comorbidities, or significant SDOH barriers.
These supports allow sites to participate in trials that match their operational reality while building long-term research capacity.
Conclusion: A 2026 Imperative
The benefits of supporting trial sites are boundless, but they are often missed because they offer “hidden” value as a byproduct of a smoother workflow. By investing in site support through flexible infrastructure, collaborative models, and hybrid trial approaches, sponsors and CROs can enable a broader range of sites to contribute meaningfully to research. The result is evidence that better reflects real-world care and supports more equitable health outcomes.
In 2026, site support is no longer a forward-looking aspiration. It is a prerequisite for credible, inclusive, and effective clinical research
Show me how MRN supports sites.
References:
- U.S Food & Drug Administration. Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs. Guidance for Industry, December 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-participation-clinical-trials-eligibility-criteria-enrollment-practices-and-trial-designs. Last Accessed December 2025.
- Bibbins-Domingo K, et al. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. National Academies Press (US); May 2022. Summary. https://www.ncbi.nlm.nih.gov/books/NBK584393/. Last Accessed December 2025.
- Metlock F E, et al. More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities. Int. J. Environ. Res. Public Health 2024, 21, 449. https://doi.org/10.3390/ijerph21040449. Last Accessed December 2025.
- Lopez MH, et al. Who is Hispanic?, Pew Research Center, September 2024. https://www.pewresearch.org/short-reads/2024/09/12/who-is-hispanic. Last Accessed December 2025.
- Espinoza-Gutarra MR, et al. The Problem of Hispanic/Latinx Under-Representation in Cancer Clinical Trials. JCO Oncol Pract 18, 380-384, May 2022. DOI: 10.1200/OP.22.00214. https://ascopubs.org/doi/10.1200/OP.22.00214. Last Accessed December 2025.
- Lee A, et al. Recruiting Community Health Centers for Implementation Research: Challenges, Implications, and Potential Solutions. Health Equity. 2024 Feb 13;8(1):113-116. doi: 10.1089/heq.2022.0195.