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.

Webinar: Remote Patient Monitoring and Children in the COVID 19 Pandemic: What’s the Opportunity and What’s the Impact?

Join us on Oct. 16 from 10 am to 11 am to discuss remote patient monitoring and its role in preserving the continuity of pediatric clinical trials amid the COVID-19 pandemic and beyond. Co-hosted by I-ACT for Children and Aparito, the virtual discussion will feature researchers and regulators in the US, Canada and Europe discussing the importance of this innovation in maximizing access to and participation in pediatric trials.

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.

Learn more about our Emergency Access Program by clicking here.

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.

The Institute for Advanced Clinical Trials for Children Announces the Appointment of Alexandre LeBeaut, MD as
Chief Executive Officer

Rockville, Maryland, May 4, 2021 - The Institute for Advanced Clinical Trials for Children (I-ACT for Children) is pleased to announce the ...
Read More

The Institute for Advanced Clinical Trials for Children Announces the Appointment of Cynthia Jackson, DO, FAAP as Chief Operating Officer

I-ACT for Children is pleased to announce the appointment of Cynthia Jackson, DO, FAAP as Chief Operating Officer, reporting to the Interim ...
Read More

Video Now Available from Webinar, Prevention = Safety: No Tears Approach to Research Compliance

We are pleased to post our webinar featuring a discussion of research compliance, understanding the value of prevention, and implementing preventive measures ...
Read More

Video Now Available from Webinar, Fair Market Value: Impact on Pediatric Clinical Trial Study Budgets

We are pleased to post our fair market value webinar, which provides a clear explanation of the meaning of “fair market value,” ...
Read More

Video Now Available from Webinar on Coverage Analysis

We are pleased to post our coverage analysis webinar. Not only does it provide a better understanding of what coverage analysis is ...
Read More

I-ACT for Children Welcomes
David Mc Neeley, MD, MPHTM

The Institute for Advanced Clinical Trials for Children welcomes David Mc Neeley, MD, MPHTM as SVP Clinical Development, Pediatrics reporting to Dr. ...
Read More