Clinical Operations at the Center: Three Pressures That Will Shape 2026 Clinical Trials

1. Site Burden: A Growing Challenge for Clinical Trial Operations

WCG’s 2024 Clinical Research Site Challenges Report found that clinical trial complexity has overtaken staffing and retention as the top challenge for 38% of sites, while staffing remained a close second at 31%. Complexity is more than an inconvenience; it cascades into delayed visits, protocol deviations, and patient attrition.

Other data underscores the impact:

• Since 2018, there has been a 61% increase in the number of vendors per trial, creating more touchpoints and oversight burden (IQVIA).
• Nearly half of surveyed sites declined to participate in trials because investigator grants were insufficient against rising operational costs (IQVIA).

For clinical operations, the message is clear: site frustration translates directly into operational risk. Reschedules, deviations, and disengagement ultimately land on ops teams to resolve.

Takeaway: When sites feel the strain, clinical operations absorb the risk.

2. Flexibility in Clinical Trial Models: Now a Core Requirement

The pandemic accelerated what had been a slow evolution. COVID-19 forced decentralized and hybrid models from “nice-to-have pilots” into operational necessity. Virtual visits, remote monitoring, and direct-to-patient supply chains kept studies moving when sites were closed or access was restricted.

That acceleration has had lasting impact:

• Global Data reported a 93% increase in decentralized/virtual trials between 2020 and 2022, reflecting how quickly these models moved from experimental to mainstream.
• Yet a Tufts CSDD survey found over 50% of sites had no prior experience with decentralized methods, underscoring that rapid adoption left many sites underprepared.

Heading into 2026, clinical operations leaders are balancing the legacy of that pivot: decentralized elements are expected by sponsors and patients alike, but they add layers of operational complexity. Ensuring that these models reduce site burden rather than shift it, and that global execution aligns with local compliance, is now a core operational responsibility.

Takeaway: Decentralized models are here to stay, but only flexible, well-planned operations keep them sustainable.

3. Cost vs. Complexity: Managing Clinical Trial Pressures

Budgets are tightening while designs become more ambitious. The WCG/ACRP 2024 report flagged study start-up as a top challenge for 35% of sites, with extended activation timelines extracting both financial and reputational costs.

Add in inflation, increased vendor oversight, and rising technology demands, and clinical operations leaders face a dual challenge: do more with less, while avoiding compromises in quality or patient experience.

Strategies that align efficiency with simplicity, such as minimizing redundant vendors, reducing unnecessary assessments, and proactively budgeting for regulatory and technology overhead, will protect both clinical trial integrity and patient continuity.

Takeaway: Simplification is the new strategy for balancing tighter budgets with more ambitious clinical trial designs.