Focus Area: Clinical Trials & Research

Advancing International Pediatric Clinical Research Webinar Series

Webinar

Published on: October 6-7, 2021

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.
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PART ONE: INFORMING THE FUTURE FROM COVID-19 LESSONS LEARNED

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:

SESSION 1SESSION 2
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.

PART TWO: Time to Listen: Hearing from Young People in Clinical Research

The second conference in the series, “Time to Listen: Hearing from Young People in Clinical Research,” focused on the perspectives of young people and the adults who care for them in clinical research and product development. The two hour webinar featured a moderated panel and 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 1SESSION 2
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		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

Time to Listen – Hearing from Young People in Clinical research

Prioritizing Young People’s Voices in Clinical Research: Part 1

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.

PART THREE: Assent and Consent in the Field: Culture, Context, and Respect

The third conference in the series, “Assent and consent in the field: culture, context, and respect,”  focused on the cultural context of assent and the challenges and solutions encountered on the ground. The 2-hour agenda featured a moderated panel of experts who shared their experiences with assent around the world, including how to manage the tension between an (ideal) ethical framework and cultural context. The webinar was hosted twice on 28 June 2022 at 9-11 am EDT & 29 June 2022 at 8-10 pm EDT with similar content but different speakers and panelists, to allow for wide attendance and global participation.

SESSION 1SESSION 2
June 28, 2022 (9-11 AM EDT)

Keynote speakers
Dr. Dylan Graetz & Dr. Victor Santana, St. Jude’s Hospital, USA

📄  SESSION 1 AGENDA
🎥  Watch SESSION 1 webinar recording
⬇️   Download SESSION 1 slides		June 29, 2022 (8-10 PM EDT)

Keynote speakers
Professor Phaik Yeong Cheah, University of Oxford, MORU Tropical Health Network Thailand

📄 SESSION 2 AGENDA
🎥  Watch SESSION 2 webinar recording
⬇️   Download SESSION 2 slides

Prioritizing Young People’s Voices in Clinical Research: Part 2

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 shared their experiences with assent and consent in the field.
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.

PART FOUR: Facilitating Pediatric Medicines Development: Models of Global Cooperation

The fourth conference in the series, “Facilitating Pediatric Medicines Development: Models of Global Cooperation,” focused on global regulatory cooperation with an eye to building on existing models to strengthen the global regulatory ecosystem for pediatric drug approval. This two-part webinar took place on 29 November 2022 at 9-11:30am ET and 30 November 2022 at 9-11am ET; participants were encouraged to attend both parts of this virtual meeting as Part 2 built on Part 1.

PART 1PART 2
November 29, 2022 (9-11:30 AM EDT) 

📄  PART 1 Agenda
🎥  Watch PART 1 webinar recording
⬇️   Download PART 1 slides		November 30, 2022 (9-11 AM EDT) 

📄 PART 2 Agenda
🎥  Watch PART 2 webinar recording
⬇️   Download PART 2 slides

Prioritizing Young People’s Voices in Clinical Research: Part 3

PART FIVE: Promoting Global Clinical Research in Children: Informing the Future

The fifth and final conference in the FDA-supported virtual conference series “Promoting Global Clinical Research in Children: Informing the Future” showcased select resources and materials from the larger body of work created, and the four webinars held, throughout the work of the MRCT Center pediatric working group initiative.

This series is supported by an FDA Scientific Conference Grant.

📄  Agenda and Bio Book
🎥  Watch webinar recording
⬇️  Download webinar slides

MRCT Post-Trial Responsibilities Toolkit Version 1.1

Released on: December 6, 2017

Developed by: MRCT Center Post-Trial Responsibilities Workgroup

View Toolkit
2017-12-07 Post-Trial Responsibilities Toolkit Version 1.1_updated_25-07-01Download
Post Trial Responsibilities: Continued Access
Principles of Post-Trial Responsibility: Continued Access to an Investigational Product
Framework: Post-trial, Continued Access Responsibilities to Investigational Medicines
Framework: Post-trial, Continued Access Responsibilities to Investigational Significant-Risk Devices – Scenarios that require further consideration

How to Submit Comments on Glossary Definitions via JIRA

Video

Date: June 6, 2025

Description: Clinical Data Interchange Standards Consortium (CDISC) offers a quarterly public review period, a time when feedback on its new standards can be collected from its users.  The plain language definitions developed for the MRCT Center Clinical Research Glossary are included as a CDISC standard.  This helpful video explains how to submit public comments to JIRA, a software application that tracks comments in an organized way.

Public Review for new terms in the Clinical Research Glossary occurs annually – and is now open (June 6 – July 5, 2025).

Click here to read more about our collaboration with CDISC to expand access to the MRCT Center’s Clinical Research Glossary.