Despite the introduction of legislation to increase the quality of evidence from rigorous testing in children, most drugs used remain “off-label” in pediatrics today. The design and execution of pediatric clinical drug development plans continues to be inefficient, slow and expensive. That means children may have to wait for a decade or more to get access to pediatric medicines initially approved for use in adults.

I-ACT for Children is dedicated to closing that gap by improving efficiency and success from study design to trial execution.

Pediatric Drug Development by the Numbers

5-10 Years

From Adult Drug Approval To Pediatric Labeling

40%

Of drugs are Prescribed “Off-Label” In Children

Risk

60%

Of Pediatric Trials Stall

40%

Of Pediatric Trials Fail

Shortage

Trial Demand Surpasses Available Patients, Sites and Investigators

Time

Startup Time: 12-16 MO.

(6 Months Adult Trials)

Duration: ~ 15 Years

(8-10 Years Adult Trials)

What I-ACT for Children Offers

I-ACT for Children brings together pediatric research stakeholders to help biopharmaceutical companies develop proprietary projects more efficiently. We also advance drug development through the following capabilities.

We’re changing the paradigm of pediatric clinical trials by providing:

Efficiency By Design

Study design and feasibility guidance for a successful foundation

  • Plans and protocols that consider perspectives of patients, parent/patient advocates, caregivers and sites to drive enrollment strategies and trial participation
  • Data-driven assessments of trial-targeted pediatric patients: rapid analyses of multiple real-world databases and site-specific feasibility surveys
  • Advice on state-of-the-art methodologies to optimize trial sample sizes
  • Expert advisors that identify emerging trends impacting trial feasibility and timelines
  • Optimal alignment of Pediatric Study Plans (PSPs) and Pediatric Investigational Plans (PIPs) to enable accurate timelines and costs

Trial-Ready Sites

Trial-ready sites to accelerate study startup and execution timelines

  • Pre-qualified network of global pediatric clinical trial sites
  • Established collaboration with other global site networks
  • Expertise in multiple pediatric therapeutic areas
  • The Pediatric Improvement Collaborative for Clinical Trial Research (PICTR), a robust quality improvement collaborative to streamline processes and timelines
  • Built-in, across-site mentoring program
  • Continuing education program developed and administered by I-ACT for Children

Expert Resources

Access to operational, medical and regulatory experts to enable innovation and improve outcomes

  • Established panels of therapeutic and disease-specific experts that rapidly convene to advise sponsors/CROs
  • Connections to patient/parent advocacy groups and patient opinion leaders in advising sponsors on development of plans/protocols
  • Rapid access to our Pediatric Regulatory Expert Panel
  • Proven leader in organizing key stakeholders to develop and advance innovative methodologies to improve efficiency and quality of pediatric drug development (pre-competitive activities)