The Mission of I-ACT for Children is

To serve as a neutral and independent organization on behalf of children everywhere, bringing a dedicated voice to the advancement of new medicines and devices needed now and in the future.  Our work is to engage public and private stakeholders through research and education to ensure that healthcare for children is continually improved by enhancing the awareness, quality and support for pediatric clinical trials.

Duchenne Platform Trial Stakeholder Meeting

I-ACT for Children and Parent Project Muscular Dystrophy co-hosted a stakeholder meeting on Sept. 9, 2019, to seek input on a draft platform trial protocol that is designed to allow multiple investigational treatments for Duchenne muscular dystrophy to be tested at one time – which could lead to more rapid completion of testing and approval of new therapies and minimize patients’ exposure to placebo. FDA’s Dr. Janet Woodcock and Dr. Billy Dunn were featured speakers at the meeting, which also was attended by researchers, parents, advocacy groups, industry representatives and other FDA scientists.

Pediatric Research Innovation Forum

I-ACT for Children hosted its 1st annual Pediatric Research Innovation Forum on Oct. 15-16, which focused on the inclusion of adolescents in adult clinical trials. The goal of the meeting was to drive innovation in this area by bringing key stakeholders together to agree on what’s known, identify continuing challenges and propose solutions to address those challenges.

Our Projects

I-ACT for Children is involved in a host of projects, both proprietary and in the pre-competitive space.

Pediatric Trials face many hurdles that adult trials do not. Because of this, pediatric trials often take longer and fail more frequently.

Of drugs used in children






Used in neonates

Are prescribed off-label, without adequate data.

Innovative drug development in pediatrics remains slow and inefficient.

We act because every child with a medical need deserves the best chance possible. That chance depends on a commitment to innovation, quality and urgency in advancing medical therapies specifically for children.

How I-ACT for Children is Improving Pediatric Clinical Trials

We lead and participate in cross-sector teams that streamline and improve clinical trial processes to enhance the quality, timeliness and impact of regulatory-quality data and reduce administrative burden.

Strategy & Planning

Strategy & Planning work ranges from innovative trial design (to help reduce sample size, exposure to placebo etc.) to use of real-world data (to assess feasibility & identify optimal research sites), in an effort to enhance the trial process from the very beginning.

Infrastructure & Trial Execution

The I-ACT for Children Site Network is an infrastructure of pediatric research sites that are expert in the conduct of innovative and efficient pediatric trials.



Tools, Capabilities, Best Practices

By implementing standard processes and practices such as budgeting templates, our network can shorten its study startup time when approached by a sponsor to conduct a clinical trial. Learn more about our site network

Thought Leadership

We engaging stakeholders to generate discussion and launch groundbreaking initiatives that raise awareness of the need to advance medical therapies specifically for children and promoting a sense of urgency to achieve this goal.

I-ACT for Children Welcomes Gary Noel, MD, as Chief Medical Officer

The Institute for Advanced Clinical Trials (I-ACT) for Children is pleased to announce the appointment of Gary Noel, MD, as its Chief ...
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SHERATON SILVER SPRING | SILVER SPRING, MD SEPTEMBER 9, 2019 | 8:30 AM-4:30 PM I-ACT for Children will co-host the first Duchenne ...
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I-ACT for Children Selects Advarra as Central IRB for its Pediatric Clinical Trials Site Network

I-ACT for Children has selected Advarra as the central IRB for the I-ACT for Children Clinical Trials Site Network – a geographically ...
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Chiesi Group Joins I-ACT for Children as an Annual Member

Today I-ACT for Children welcomes Chiesi Group as our newest Annual Member. Click on the link below for more details. Full press ...
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Bayer Joins I-ACT for Children as an Annual Member

We are thrilled to welcome Bayer AG as I-ACT for Children’s newest Annual Member! Click on the image below to read the ...
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Eli Lilly and Company Joins I-ACT for Children as a Sustaining Member

We are delighted to announce that Eli Lilly and Company has joined I-ACT for Children as our newest Sustaining Member. Please click ...
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You can “ACT for Children” by donating to this effort today!

The Institute’s work relies on financial contributions from individuals, groups, institutions and others