Advancing International Pediatric Clinical Research Webinar Series

JOIN US!

The MRCT Center is delighted to announce a 5 part virtual conference series to advance the design, review, oversight, and conduct of global pediatric clinical trials. Ensuring all children have access to safe and effective medicines is contingent upon the conduct of trials that include them. For many pediatric conditions, disease incidence is low and the pool of potential participants small; conducting multisite and multinational pediatric studies is necessary to secure sufficient enrollment for completion. Given the dearth of relevant data and the challenges of working across jurisdictions, harmonized approaches for pediatric research are necessary.

To ensure wide global relevance and participation, each conference will be offered twice to better accommodate individuals across international time zones, each with the same general agenda but different speakers to hear a variety of opinions.

A special thank you to the dedicated members of the webinar series planning committee.

This conference series is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The first conference in the series was a three-hour webinar that focused on applying lessons learned—those sustained and those abandoned– during the COVID-19 pandemic to future work with children in clinical trials. We were delighted to host the keynote speakers:

October 6, 2021

Keynote Speaker:
Dr. Peter Marks
Director, Center for Biologics
Evaluation and Research (CBER),
U.S. Food and Drug Administration (FDA)

USA

📄October 6, 2021 session Agenda

🎥  Watch Day 1 webinar recording

⬇️   Download Day 1 slides

October 7, 2021

Keynote Speaker:
Prof. Mojisola Christianah Adeyeye
Director General, National Agency for Food and Drug Administration and Control (NAFDAC)
Nigeria

📄October 7, 2021 session Agenda

🎥  Watch Day 2 webinar recording

⬇️   Download Day 2 slides

 

We would appreciate feedback on these webinars. Please complete the survey to help us plan future webinars in this series that are both informative and convenient.

We invite you to browse the Day 1 & Day 2 speakers’ brief biographical details.

Each keynote speaker was followed by two moderated panel discussions to:

  1. Deliberate the appropriateness and timing of initiating trials in children, and the different age groups within the broad scope of “children,” using lessons learned from COVID-19 and applying that learning to future pediatric trials.
  2. Address infrastructure, both new and adaptations to existing structures, needed to conduct efficient and ethical pediatric clinical trials on a global scale.

This project is supported by the FDA (R13) Scientific Conference Grant Program.

The MRCT Center is delighted to announce the second of the 5 part virtual conference series to advance the design, review, oversight, and conduct of global pediatric clinical trials. Ensuring all children have access to safe and effective medicines is contingent upon the conduct of trials that include them. For many pediatric conditions, the pool of potential participants is small; conducting multisite and multinational pediatric studies is necessary to secure sufficient enrollment for completion. Given the dearth of relevant data and the challenges of working across jurisdictions, harmonized approaches for pediatric research are necessary.

The second conference in the series is entitled, “Time to Listen: Hearing from Young People in Clinical Research.” This two-hour webinar focused on incorporating the perspectives of young people and the adults who care for them in clinical research and product development. The webinar was hosted twice, from 9-11 am EST and 8-10 pm EST, with similar content but different speakers and panelists, to allow for wide attendance and global participation.

SESSION 1
February 2, 2022 (9-11 AM EST)
Keynote speakers

  • A youth guest speaker: Sophie Ainsworth, RAiISE
  • Keynote speaker: Ms. Jennifer Preston, University of Liverpool, Institute in the Park at Alder Hey, Children’s Hospital in Liverpool, England

📄  SESSION 1 AGENDA

🎥  Watch SESSION 1 webinar recording

⬇️   Download SESSION 1 slides

SESSION 2
February 2, 2022 (8-10 PM EST)
Keynote speakers

  • A youth guest speaker: Rohit
  • Keynote speaker: Dr. Sandhya Kanaka Yatirajula, Senior Research Fellow, The George Institute for Global Health, India

 

📄 SESSION 2 AGENDA

🎥  Watch SESSION 2 webinar recording

⬇️   Download SESSION 2 slides

Prioritizing Young People's Voices in Clinical Research Part 1

Time to Listen - Hearing from Young People in Clinical research

We invite you to browse the Session 1 & Session 2 speakers’ brief biographical details.

Each keynote speaker was followed by:

  • The premiere of a short video featuring several youth who address their involvement in clinical research and what they want adults to know.
  • A 1 hour moderated panel where experts responded directly to the issues and concerns raised by young people.
  • Concluding comments and introduction of new MRCT Center resources for international pediatrics research.
This series is supported by an FDA Scientific Conference Grant.

Special thanks to Dr. Gianna “Gigi” McMillan and International Children’s Advisory Network (iCAN) for their collaborative efforts in creating impactful videos that will be featured at each webinar.

high-resolution-iCAN-logo

The MRCT Center is pleased to announce the third of the 5 part virtual conference series to advance global pediatric clinical trials. Entitled Assent and consent in the field: culture, context, and respect,”  the conference will focus on the cultural context of assent and the challenges and solutions encountered on the ground. The 2-hour agenda will feature a moderated panel of experts who will share their experiences with assent around the world, including how to manage the tension between an (ideal) ethical framework and cultural context.

The webinar will be hosted twice: Tuesday 28 June 2022 at 9-11 am EDT and Wednesday 29 June 2022 at 8-10 pm EDT with similar content but different speakers and panelists, to allow for wide attendance and global participation.

REGISTER for Session 1: Tuesday 28 June 2022 at 9-11 am EDT

REGISTER for Session 2: Wednesday 29 June 2022 at 8-10 pm EDT