In short
- Pediatric infectious disease clinical trials face challenging recruitment windows, narrow patient pools, and heightened ethical considerations
- PSI’s infectious disease and pediatric trial expertise helped with sponsor-CRO oversight, navigating FWA registration requirements and BARDA approval timelines (directing protocol and operational decisions) without delaying startup
- Strategic site selection prioritized experienced pediatric infectious disease PIs with local microbiology infrastructure and established interdisciplinary communication (primarily with emergency medicine departments), maintaining enrollment momentum despite challenging patient identification
- A regional microbiology laboratory model streamlined startup while maintaining full BARDA compliance, replacing site-by-site lab qualification that would have extended timelines
- The trial is meeting its milestones, demonstrating that operational experience and regional infrastructure planning can overcome challenges associated with pediatric infectious disease trials
The challenge
Pediatric infectious disease trials demand more than protocol expertise. Acute infections create narrow enrollment windows. Biomedical Advanced Research and Development Authority (BARDA) oversight and requires site-level compliance structures many centers lack. These studies need investigators who can coordinate urgent clinical care with rigorous research procedures, and a CRO that knows how to build that network.
PSI partnered with a sponsor on a pediatric BARDA-funded infectious disease study. We combined infectious disease trial expertise with regional operational knowledge to meet milestones consistently. This case study explains how.
The operational reality of pediatric infectious disease trials
Pediatric clinical trials present distinct scientific, ethical, and operational challenges, requiring specialized expertise at every stage of study design and execution [1, 2]. Acute infections present suddenly, leaving narrow windows for screening, consent, and enrollment while coordinating urgent SoC treatment and research procedures. Eligible patient populations are small, referral pathways are fragmented, and families face the dual burden of clinical care and trial participation.
Add the requirement for age-appropriate protocols, developmental considerations, and robust consent procedures, and these trials become operationally demanding before any sites activate.
Pediatric patients are often underrepresented in infectious disease trials because few CROs build infrastructure to address these realities [1, 3]. High-quality sample collection from young children, coordination with rapid microbial diagnostics, and integration into busy clinical research environments require sites with established pediatric infectious disease expertise and multidisciplinary teams accustomed to balancing research with urgent clinical care.
The solutions
Valuable BARDA oversight adds predictable complexity
BARDA-funded trials place further emphasis on operational readiness and reliability in populations frequently underrepresented in clinical research [4]. All sites and ethics committees require Federalwide Assurance (FWA) registration [5]. All major decisions on the protocol and operations need dual review and approval by both sponsor and BARDA. Study teams must actively follow up to keep these trials on track.
For this study – almost entirely BARDA-funded – PSI conducted feasibility analyses accounting for FWA submission timelines. Early planning around these requirements turned potential bottlenecks into predictable steps.
Building a site network that could actually enroll
Successful enrollment in pediatric infectious disease trials depends on more than protocol design. It requires clinical teams experienced in engaging families under acute conditions, established relationships with emergency departments, and cross-functional coordination among investigators, laboratories, and operational staff. PSI built this trial’s site network around these principles, selecting high-performing centers identified through rigorous feasibility and pairing them with experienced pediatric infectious disease PIs.
Momentum depends on centers with:
- Local clinical expertise
- Cross-functional hospital cooperation with the emergency departments
- Established relationships across study teams
In a trial where the screening window is measured in hours, not days, these operational relationships determine whether a patient enrolls or is missed entirely.
Regional labs: Infrastructure that moves faster than central models
Qualifying multiple laboratories local to each site would have extended startup timelines and introduced unnecessary operational complexity. Instead, we prioritized countries with qualified regional microbiology laboratories, streamlining startup while maintaining full compliance with BARDA requirements.
Combining this infrastructure approach with regional operational knowledge allowed PSI to select countries with existing coordination. The result: faster site activation, predictable sample processing, and enrollment momentum that began during startup and was maintained throughout the trial.
The outcome
Milestone achievement in a difficult indication
The study is meeting its milestones. The momentum built in the startup phase – through strategic site selection, regional laboratory infrastructure, and BARDA-experienced operational planning – is being maintained as the trial progresses.
Congratulations! And gratitude to [the trial Project Manager] and the PSI team for being our valued partner on this […] incredibly important journey!
Key takeaways
This case study highlights a straightforward principle: Pediatric infectious disease enrollment becomes predictable with the right operational expertise, site network decisions, and access to established regional infrastructure. Choose a CRO with proven experience in complex infectious disease trials.
Explore our industry-leading infectious disease services
Abbreviations
BARDA, Biomedical Advanced Research and Development Authority;
FWA, Federalwide Assurance.
References
1. World Health Organization. The future of paediatric clinical trials – setting research priorities for child health. 2025. Accessed March 2026. Available from: https://www.who.int/publications/i/item/9789240116597.
2. Vamshy, J.K., et al., Recent Advances in Pediatric Infectious Diseases: A Review of Diagnostic and Therapeutic Strategies. Cureus, 2025. 17(10): p. e94523.
3. Berkley, J.A., et al., Strengthening the paediatric clinical trial ecosystem to better inform policy and programmes. The Lancet Global Health, 2025. 13(4): p. e732–e739.
4. Medicalcountermeasures.gov. About BARDA. 2026. Accessed March 2026. Available from: https://www.medicalcountermeasures.gov/barda.
5. U.S. Department of Health and Human Services. Register IRBs & Obtain FWAs. 2026. Accessed March 2026. Available from: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html.
