Report Published from I-ACT for Children’s Innovation Forum on Inclusion of Adolescents in Adult Clinical Trials

I-ACT for Children is focused on innovation in clinical trials as a means to facilitate pediatric medicines development. The report of a recent conference on the inclusion of adolescents in adult clinical trials has now been published in the journal Therapeutic Innovation and Regulatory Science.

Noel, G.J., Nelson, R.M., Bucci-Rechtweg, C. et al. Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum. Ther Innov Regul Sci (2021)

2020 Annual Report

Even amid the challenges of 2020, I-ACT for Children achieved important progress in our efforts to accelerate and enhance the quality of pediatric clinical trials. We have highlighted these and other efforts in I-ACT for Children’s first Annual Report.

I-ACT for Children announces Emergency Access Program to speed pediatric COVID-19 research

The COVID-19 Emergency Access Program allows all biopharmaceutical and other companies developing COVID-19 treatments and vaccines to use the organization’s pediatric research network to conduct their pediatric trials.

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.

Read more about the challenges facing pediatric trials

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.
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