Bridging the Feasibility Gap: A Smarter Path to Clinical Trial Enrollment

Despite decades of progress in data access and analytics, the clinical research industry continues to struggle with one seemingly simple challenge: enrolling patients on time.

The statistics are stark: nearly 80% of clinical trials fail to meet enrollment timelines, and 9 out of 10 end up doubling their planned duration to reach target enrollment. These delays aren’t just scheduling inconveniences. They carry staggering financial consequences and, most critically, delay access to potentially life-saving therapies for patients who need them most.

The problem isn’t a lack of data. It’s that the data exists in disconnected silos.

The Hidden Problem: The Feasibility Gap

At H1, we’ve identified a fundamental issue plaguing clinical trial planning: the Feasibility Gap. This represents the inability to access integrated country, site, and investigator data during the planning phase: a disconnect that’s costing sponsors millions and delaying critical treatments for patients worldwide.

Consider this scenario: A clinical feasibility team selects Germany, Spain, and Italy for a Phase III oncology trial based on solid epidemiological data. Months later, the site selection team identifies leading cancer centers in each country. Finally, the clinical team engages investigators, only to discover most qualified researchers are already committed to competing trials.

This sequential approach isn’t a planning failure. It’s a data access limitation. Country-level data exists in regulatory databases, site information lives in sponsor CTMS systems, and investigator details are scattered across relationship management platforms and personal networks. Without connected data systems, even the most experienced teams are forced into this fragmented process. The result? One in ten trial sites fail to enroll even a single patient, and each day of delay can cost between $600,000 and $8 million.

The True Cost of Fragmented Planning

The financial impact extends far beyond obvious operational expenses:

Direct Costs

• Delayed market entry and extended operational budgets

Opportunity Costs

• Competitive disadvantage from slower development timelines

Regulatory Risks

• Trials failing to enroll representative populations may face additional requirements

Site Management

• Resources wasted on non-performing locations that require replacement
  Most importantly, every delay means patients continue waiting for potentially life-changing treatments.

A Smarter Approach: The Three-Tier Framework

When teams have access to connected data across all three levels, they can adopt an integrated approach that connects insights across three critical levels:

1. Strategic Country Selection

Effective country selection goes beyond basic prevalence data to incorporate real operational intelligence. This includes understanding standard of care variations, regulatory nuances, cultural attitudes toward clinical research, and historical enrollment patterns. The goal is connecting high-level strategy with downstream realities before committing resources.

2. Site-Level Intelligence

Not all sites are created equal, even within the same therapeutic area or geographic region. With access to comprehensive site data, the most successful trials look beyond basic capacity metrics to understand protocol fit, infrastructure capabilities, patient demographics, therapeutic experience with similar studies, referral networks, and competitive trial saturation. This granular view helps predict which sites will actually deliver on enrollment projections.

3. Investigator-Level Insights

Individual investigators ultimately determine enrollment success, yet without integrated data systems, many feasibility assessments are limited to surface-level metrics like “number of trials conducted.” Connected data enables a more accurate picture that includes investigator experience with similar protocols and patient populations, investigator access to diverse patient populations, current trial commitments, referral networks, and their historical enrollment performance compared to projections in previous trials.

Why Integration Matters Now

As trial protocols become increasingly complex and regulatory bodies demand more representative populations, the limitations of fragmented data systems have never been more costly. Without real-time visibility across all three tiers, sponsors are forced into reactive decisions: replacing sites mid-trial, expanding into new countries late in the process, or extending timelines to meet enrollment goals.

These reactive “fixes” are both expensive and inefficient, often requiring sponsors to essentially restart portions of their feasibility assessment months into execution.

The H1 Solution

H1’s integrated platform solves the data connectivity challenge by unifying insights from 500,000+ sites and 11 million+ investigators with comprehensive data on trial experience, enrollment patterns, and patient access — all accessible through a single interface.

• This integration enables clinical teams to:
• Make proactive decisions based on complete visibility across all planning tiers
• Identify and avoid potential enrollment bottlenecks before they impact timelines
• Build more accurate enrollment projections by incorporating investigator availability and patient access data

Design trials that meet both scientific and regulatory requirements for population diversity. The result is faster enrollment, reduced costs, and accelerated delivery of new therapies to patients.

Moving Forward

The Feasibility Gap isn’t an inevitable part of clinical development. It’s a solvable problem that requires access to integrated data. By providing teams with connected data that treats feasibility as an integrated process rather than a series of disconnected assessments, sponsors can significantly improve their enrollment success rates and overall trial efficiency.

Ready to see how connected feasibility data can transform your clinical development process? Request a demo to learn how H1 can help you bridge the Feasibility Gap and accelerate your path to market.