Because Children Can't Wait!

The Institute for Advanced Clinical Trials for Children (IACT4C) is a 501(c)(3) non-profit organization established to drive innovation to improve and expedite pediatric drug development.

Our work is not just about advancing the development of new therapies; it's about giving children with medical conditions a better chance at a high quality of life, allowing them to flourish despite their condition, which for some, can be a matter of life or death.

IACT4C engages subject matter experts, academics, regulatory agencies, drug developers and patient advocates in our mission. Together, we foster an environment that finds solutions to the many challenges for safe and effective pediatric drug development.

*“The launch of I-ACT for Children is an important milestone in the global effort to collect reliable data to accelerate treatment development for our pediatric patients.”***

Janet Woodcock M.D.

Director of the Center for Drug Evaluation and Research, FDA

“I-ACT helped our site to work strategically, improving our study feasibility and start-up process. The collaboration with the I-ACT for Children team and other sites was extremely valuable. We are thankful for the groundwork we received by being a part of the network.”

Lauren Davis

Le Bonheur Children’s Hospital

“Participation in I-ACT’s site network has stimulated in-depth evaluation of our research process. This led to the development of an internal feasibility questionnaire for sponsors to complete which ultimately eliminated multiple emails and helped streamline this process. ”

Dr. Janice Sullivan

Norton Children’s Hospital University of Louisville School of Medicine

We Serve Children - Because Children Can't Wait

Children need safe and effective new drugs now.

On average, it takes 10 years to develop and approve a new drug for adults and an additional 8-9 years for a drug to be developed and approved for the same use with pediatric patients, a problem known as the "pediatric gap."

In addition, more than 40% of drugs used in children and 90% of those used in newborns are prescribed without adequate data to verify their efficacy and safety for children. At the core of this frustrating situation is the challenge of timely execution of a clinical development program in children: 40% of clinical trials for children fail, 60% stall, and 30% never enroll a single patient.

Consequently, many drugs are prescribed and used off-label in pediatrics. The disparity between the availability of novel drugs for adults versus children is unacceptable. There are many root causes, but key factors include the need for an integrated and sustainable trial infrastructure, operational efficiencies and patient recruitment.

Our 9 to 5 Project: Closing the Pediatric Gap

IACT4C is committed to reducing this “Pediatric Gap” from 9 to 5 years; we call this “The 9 To 5 Project”. This ambitious 5-year goal is not just a target but a necessity. It's a race against time to ensure that children have access to safe and effective drugs when they need them the most, potentially saving countless lives.

Child lying in the hospital in an oxygen mask and her mother looking at her

The 9 to 5 Project is more than a mission,

it's a race against time...

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