Redesigning Reach: Community-Based Research In Action – Part 2
Our series highlighting industry perspectives on community-based research continues. In partnership with Citeline, we surveyed 130 leaders from biotech companies, pharmaceutical organizations, and CROs to understand how they view emerging community‑centric efforts to bring trials closer to patients. In part 1, we explored the key findings from the survey. Here, we take a closer look at the biggest perceived barriers preventing broader adoption of community-based research.
What’s holding them back?
Among survey participants, only 25% reported that their organizations have fully implemented community‑based research models. While many are piloting new approaches, enthusiasm is often tempered by logistical and structural challenges. Most leaders recognize the potential of community-based research, but some still question how to operationalize it effectively.
The most commonly cited barriers were:
- Patient adherence and engagement
- Logistical and supply chain challenges
- Data consistency across visits
Respondents who remain hesitant noted concerns that community-based research may expose gaps in operational readiness. Tasks like clinician assignment, data capture, and supply management are already challenging in traditional site settings, and some worry that conducting research outside brick‑and‑mortar environments introduces additional complexity.
Among those who have not yet adopted this model, 43% said their biggest hesitation is data quality compared with traditional site‑based approaches. In conventional models, data oversight is anchored to physical infrastructure, making some stakeholders cautious about moving trial activities into more distributed settings.
Shifting mindsets
To maintain compliance and uphold data integrity, sponsors must establish robust systems for training, data capture, and quality control across all environments. For some reluctant adopters, this feels like a heavy lift. Yet nearly half of survey respondents stated they believe data quality actually improves in community‑based designs, while only 11% reported concerns about lower quality. This signals a meaningful shift in sentiment and challenges the assumption that home or mobile methods weaken oversight.
Distributed trial settings do bring added complexity – staff training, oversight models, technology integration, and GCP compliance among them. However, industry leaders who have successfully executed decentralized approaches point to one common success factor: a supportive, purpose‑built infrastructure that reinforces scientific rigor across home visits, community settings, and mobile sites.
There is a growing consensus that access and diversity are no longer “nice‑to‑have” metrics; they’re strategic imperatives. But ambition must be matched by executable, audit‑ready processes. The latest FDA guidance echoes this shift. Sponsors are now expected to prioritize broad patient representation as part of core scientific strategy, not as a downstream compliance task.
The real question is no longer if sponsors and CROs should adopt community‑based strategies, but when. Organizations that delay risk falling behind more forward‑thinking peers.
Looking forward
With patient participation still limited by longstanding accessibility barriers, the industry cannot afford the delays and dropout rates that slow timelines, increase costs, and hinder pipeline momentum. Reducing barriers and expanding patient optionality are essential to improving accessibility and patient outcomes.
This shift can’t be driven by FDA guidance or by technology alone. It must be championed by organizations willing to lead, evolve, and embed community-based research into their operating strategies. At EmVenio, our team is transforming clinical research by moving beyond traditional sites and into communities. We make trials more accessible without compromising oversight or data integrity.
Curious how we put this into practice? Contact us to learn how our community-based model can support your next study.
Stay tuned as we continue this series in part 3, where we’ll explore how sponsors and CROs can move community‑based research from an emerging trend to a core strategic pillar.