Insufficient patient enrollment is one of the main reasons clinical trials fail

When we help a sponsor not only complete enrollment, but complete it 30 days early, we consider it a win worth sharing.

Here’s what happened: A global diagnostics company partnered with Fortrea on a pivotal trial to evaluate one of its assays. Although physicians use the assay on a broad patient population, enrollment had stalled and sites were frustrated.

A few challenges included:

• Enrolling over 5.000 patients in medical distress: The study needed patients who presented to emergency departments with signs and symptoms of acute distress. Encouraging participation and obtaining consent required fast action at the right time
• Winning over reluctant sites: The study launched in late 2020, in the middle of the COVID-19 pandemic. Potential sites struggled with staffing shortages, rigorous safety protocols and general uncertainty related to COVID-19. With so many additional stressors, sites hesitated to participate
• Relieving site burdens: Study teams initially reported delays in EDC data entry as well as data monitoring backlogs. Site-sponsor contract negotiations were also taking longer than expected

Fortrea worked across continents to exceed expectations

Solving these problems required global coordination, aggressive patient recruitment and meticulous project management. Fortunately, Fortrea has the expertise and resources to solve complicated problems.

Here are a few strategies we used:

• To meet enrollment goals, Fortrea leveraged its global site network and data-driven selection process to expand the number of sites to 50 facilities across North America, Europe and Asia. We also worked closely with sites to make it easier to recruit and enroll patients.
• We simplified the data collection and data entry processes for sites. This helped improve productivity and soon resolved data collection and data entry difficulties.
• Targeted monitoring, focusing on aspects most likely to impact patient safety and data credibility, cleared backlogs for data monitors. Once they were caught up, they could more efficiently oversee protocol compliance.
• We planned and delivered several in-person team-building events to boost morale and build trust among team members. We also developed sample collection training videos which helped protect data quality.
• With additional governance and project management support, Fortrea developed plans that aligned with the client’s outsourcing structure and future pipeline.

And we got to the finish line 30 days early

By thinking strategically and eliminating inefficiencies, Fortrea completed site selection and activation on time. Even better, we completed EU enrollment one month ahead of schedule.

By taking a partnership approach, Fortrea supported the sponsor with outsourcing and additional governance strategies. Fortrea also worked with the adjudication vendor and the sponsor to enhance data cleaning and adjudication, all while implementing plans to improve data entry and monitoring.

When the pivotal trial wraps up, the results will help the sponsor understand how its assay can improve outcomes in life-threatening situations. By enabling physicians to triage patients more quickly, and accurately, the assay has the potential to reduce hospital admissions without increasing adverse events.

Why Fortrea excels in diagnostics

As a diagnostics leader for over 30 years, Fortrea makes life-changing healthcare solutions possible. With insight-driven expertise, Fortrea works with diagnostics companies through all phases of development, from safety to postmarket support.

Our clinical validation services include:

• Feasibility studies
  
• Clinical strategy development
• Study design
• Study operations
• Safety monitoring and management
• Datenmanagement
• Biostatistical analyses
• Clinical auditing
• Medical writing

The recruitment and enrollment challenges presented by the diagnostics pivotal trial were significant but within reach for Fortrea. With a global site network, sophisticated technology and a full roster of diagnostics development professionals, Fortrea makes the exceptional possible.

Are you ready to advance your diagnostics? Request a meeting today.

Study facts

Prospective, noninterventional, single arm, longitudinal cohort multicenter study

• Sites: 50
• Countries: 11 (USA, China, Japan, Austria, Bulgaria, Germany, Netherlands, Norway, Spain, Switzerland, United Kingdom)
• Patients: 5.600 (USA, 3,250; APAC, 1,050; Europe, 1,300)

NOTE: This study is still in progress as of 07/25/2024