ICON Survey Exposes Escalating Delays in Clinical Trial Startups—Calls for Human-Centred Site Activation Solutions
biotechnology, artificial intelligence, and precision medicine, the clinical trial landscape should be accelerating. Yet, a new industry survey fromICON plc (NASDAQ: ICLR)—a global leader in clinical research—reveals the opposite: clinical trial startup timelines are stretching longer, site frustrations are mounting, and systemic inefficiencies continue to stall the delivery of life-saving therapies to patients. The findings underscore a critical, yet often overlooked, truth: technological innovation alone cannot overcome deeply rooted human and operational challenges. What’s needed now is a fundamental shift toward human-centred site activation strategies that prioritize collaboration, empathy, and streamlined processes.
Released in June 2025, ICON’s latest survey gathered insights from just over 100 principal investigators and senior clinical trial site personnel across a diverse range of therapeutic areas and geographies. Notably, the survey was not limited to sites working on ICON-managed trials, ensuring a broad and unbiased view of industry-wide pain points. The results paint a sobering picture: despite industry-wide investments in digital transformation and operational efficiency, site teams continue to grapple with outdated workflows, fragmented communication, and burdensome administrative demands—particularly during the crucial startup phase of clinical trials.
Persistent Startup Delays Hamper Trial Momentum
The survey reveals that more than half of respondents—55%—report that the time between site selection and full activation now exceeds five months. Even more concerning, 39% noted that startup timelines have grown longer compared to just two years ago. In an environment where every week counts in bringing new treatments to market, these delays represent not only financial inefficiencies but also real-world consequences for patients awaiting novel therapies.
The root causes are both systemic and relational. Among the most frequently cited bottlenecks are delays in contract finalization and budget negotiations—issues reported by 66% of respondents as occurring “frequently.” These administrative hurdles are not merely logistical inconveniences; they erode site morale, disrupt staffing plans, and can ultimately lead sites to decline participation altogether. Alarmingly, ICON’s own analysis of pharmaceutical and biotech trials between 2021 and 2023 shows that site pre-selection decline rates have risen sharply—from 35% to 47%—a trend directly tied to the frustrations highlighted in the survey.
Communication Gaps Undermine Collaboration
Perhaps the most telling statistic lies in site perceptions of sponsor and CRO communication: 47% rated their interactions as “average” or “poor.” This signals a profound disconnect between trial sponsors/CROs and the front-line teams responsible for executing studies. When asked where sponsors and CROs could most improve, an overwhelming 92% of respondents pointed directly to contract and budget processes—the very areas plagued by delays and misalignment.
“AI and operational advancements are opening new possibilities for smarter, faster trials,” said Brian Mallon, Executive Vice President of Site and Patient Solutions at ICON. “Yet many sites still face persistent challenges that delay activation and disrupt momentum. These delays are solvable. Sponsors have a clear opportunity to improve communication and adopt approaches that centre on the human experiences of site personnel. By simplifying documentation, smoothing negotiations, and fostering open collaboration, we can build a thriving ecosystem for trial start-ups—one that prioritises site needs and accelerates access to new therapies.”
Mallon’s comments reflect a growing industry consensus: efficiency gains must be matched by empathy and partnership. The trial ecosystem cannot thrive if sites are treated as transactional vendors rather than strategic collaborators.
The Human-Centred Imperative
In response to these findings, ICON has published a new whitepaper titled “From Bottlenecks to Breakthroughs: Human-Centred Solutions for Faster Study Starts.” The report goes beyond diagnosing problems—it offers a roadmap for transformation grounded in human experience, data intelligence, and operational pragmatism.
The whitepaper emphasizes that “site-centricity” is not a buzzword but a necessity. It calls for a fundamental reorientation of trial startup processes around the realities faced by site staff: limited bandwidth, competing priorities across multiple sponsors, and the emotional toll of repeated administrative friction. To that end, ICON outlines four key strategies for accelerating startup while strengthening site relationships:
1. Balanced Site Engagement That Respects Competing Priorities
Sites often manage trials from multiple sponsors simultaneously, each with its own timelines, documentation requirements, and communication styles. A human-centred approach means aligning startup activities with site capacity—not forcing rigid, one-size-fits-all workflows. ICON advocates for early, transparent dialogue about expectations, resource needs, and milestone planning to foster mutual understanding and realistic commitments.
2. Human-Enabled Predictive Analytics for Smarter Site Selection and Negotiation
While AI and machine learning offer powerful tools for identifying high-performing sites, their true potential is unlocked only when combined with human insight. ICON’s approach integrates predictive analytics with real-world site feedback to pre-empt budget and contract sticking points. For example, historical data on a site’s past negotiation timelines or payment terms can inform more accurate, efficient discussions—reducing back-and-forth and building trust from the outset.
3. Data-Informed Over-Selection to Mitigate Attrition
Given the rising rate of site declines post-pre-selection, sponsors can no longer afford to assume all initially identified sites will come onboard. ICON recommends using data-driven over-selection—intelligently identifying more sites than needed based on predictive risk factors like therapeutic experience, regulatory history, and past responsiveness. This buffer allows for smoother activation even when some sites drop out, without derailing overall timelines.
4. Coordinated Site Networks and Structured Governance
Fragmented communication between sponsors, CROs, IRBs, and sites creates confusion and delays. ICON proposes implementing structured governance models—such as integrated startup teams with clear roles, escalation paths, and shared dashboards—that keep all stakeholders aligned. Coordinated site networks, where regional hubs share best practices and resources, can further amplify efficiency and consistency.
Beyond Efficiency: Building a Sustainable Trial Ecosystem
The implications of ICON’s findings extend beyond operational metrics. Chronic startup delays don’t just slow down trials—they contribute to site burnout, investigator turnover, and declining interest in clinical research altogether. In a landscape already facing a global shortage of qualified trial sites, preserving and nurturing site relationships is not optional; it’s existential.
Moreover, delays have direct patient impact. Every week a trial is delayed is another week patients wait for access to potentially life-changing therapies. A human-centred approach isn’t just about making life easier for sites—it’s about honoring the shared mission that unites sponsors, CROs, sites, and patients: advancing medical science to improve human health.
A Call to Action for the Industry
ICON’s survey and whitepaper serve as both a warning and an invitation. The warning: if the industry continues to prioritize systems over people, delays will worsen, sites will disengage, and patient access will suffer. The invitation: reimagine trial startup as a collaborative, empathetic, and streamlined journey—one where sites are empowered, not encumbered.
As Mallon puts it: “The solutions exist. What’s required is the will to implement them—not as isolated tactics, but as a cultural shift toward partnership and respect.”
For sponsors and CROs ready to lead this transformation, the path forward is clear. It begins with listening to sites, leveraging data with purpose, and designing processes that reflect the realities of those on the front lines. Only then can the promise of faster, smarter, and more patient-focused trials become a reality. For more insights and to download the full whitepaper, visit www.ICONplc.com/startup.
Source Link: https://www.iconplc.com/
