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.

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

Advancing International Pediatric Clinical Research: Facilitating Pediatric Medicines Development

Webinar

Presented on: November 29 & 30, 2022

Presented at: Advancing International Pediatric Clinical Research webinar series: Facilitating Pediatric Medicines Development: Models of Global Cooperation

Part One

Download Slides Here >

Part Two

Download Slides Here >

Related Resources

See related webinars, maintained on our website

Informing the Future from COVID-19 Lessons Learned 

Time To Listen: Hearing From Young People in Clinical Research

Assent and consent in the field: culture, context, and respect

FDA Office of Minority Health and Health Equity Webinar Introducing MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Supplemental Toolkit

September 22. 2022

Location: Virtual

Discussion topic:  The FDA Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck).

Drs. Bierer and Clark will introduce the recently released MRCT Center’s Diversity Framework, titled Achieving Diversity, Inclusion, and Equity In Clinical Research. After providing a brief introduction, background, and contextual orientation to listeners, Drs. Bierer and Clark will highlight the ways in which stakeholders can contribute to increasing diverse representation in clinical research and, ultimately, improving health equity and public health domestically and abroad.

🎥  Watch webinar recording          ⬇️   Download slides

Launch Of Equity By Design (EBD) In Clinical Research: The EBD Metrics Framework

Webinar Presentation

Presented on: June 30, 2022

Presented at: MRCT Center webinar and public launch, “Equity by Design (EbD) in Clinical Research: The EbD Metrics Framework”

Dr. Barbara E. Bierer moderated this webinar, in which MRCT Center Program Manager Dr. Willyanne DeCormier Plosky introduced the background and structure of EbD Metrics Framework and panelists Yasmeen Long (Faster Cures, Milken Institute) and Dr. Rodrigo Garcia (PPD, Thermo Fisher Scientific) discussed their experiences in testing and utilizing it.

The EbD Metrics Framework is a tool developed by the MRCT Center in collaboration with colleagues from professional, trade, academic, regulatory, and patient advocacy organizations. It is designed to advance organizational diversity, equity, and inclusion (DEI) efforts; orient users toward potential entry and follow-up strategies; and provide guidepost measures for assessing and reporting on progress. To access the tool, please visit the EbD Metrics Framework page.

Webinar

Presentation Slides

Presentation Transcript

Advancing International Pediatric Clinical Research: Assent and Consent in the Field: Culture, Context, and Respect

Webinar

Presented on: June 2022

Presented at: Advancing International Pediatric Clinical Research webinar series: 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.

Webinar

Related Webinars

Informing the Future from COVID-19 Lessons Learned 

Time To Listen: Hearing From Young People in Clinical Research

Supporting IRB Efforts To Advance Diversity And Inclusion In Clinical Research Tools And Resources

Webinar Presentation

Presented on: June 23, 2022

Presented at: MRCT Center webinar and public launch, “Supporting IRB Efforts to Advance Diversity and Inclusion in Clinical Research”

Does the IRB play a role in addressing the problem of diversity, inclusion, and equity in clinical research? It is true that the need for change must be systemic and embraced at all levels of the clinical research enterprise, and while IRBs are not the primary driver for assuring diversity, inclusion, and equity in clinical research, IRBs can and should serve as a checkpoint for reviewing research for the principles of DEI. This webinar introduced tools and resources created for IRBs and HRPPs to help drive the change.

Presentation Slides

Launch of Online Health Literacy Training For IRB Members and Staff

Webinar

Presented on: June 14, 2022

Presented at: MRCT Center webinar and public launch

The IRB can play an important role in championing the creation of research materials for participants that are clear and understandable. Please join us as we launch a new online Health Literacy training for IRB members and staff. The webinar launch will review health literacy concepts and introduce the online training which is designed to be a self-paced opportunity to learn and apply health literacy principles to the IRB role. The training also offers a facilitation guide to support continued conversations with colleagues about how to implement lessons learned.

Webinar

Presentation Slides


Return of individual research results (IRR) website launch webinar

Webinar

Presented on: March 24, 2022 at 1:00 pm to 2:00 pm ET

Location: Virtual

The practice of returning IRR is consistently identified by participants as something that participants not only desire but also expect. Returning IRR demonstrates participant-centricity and respect.

A taskforce was convened during 2021 to update and further develop the MRCT Center’s guidance on Returning Individual Research Results to Participants – these resources and tools are ready to be shared, on a new, easy-to-navigate, dedicated website.

This one-hour webinar will include a review of IRR and its importance, a patient advocate describing her own lived experience with IRR, and a live demonstration of the new tools and website.

Presentation Slides

Advancing International Pediatric Clinical Research: Time To Listen: Hearing From Young People in Clinical Research

Webinar

Presented on: February 2, 2022

Presented at: Advancing International Pediatric Clinical Research webinar series: Assent and Consent in the Field: Culture, Context, and Respect

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.

Related Webinars

Informing the Future from COVID-19 Lessons Learned  

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