Discussion Topic: MRCT Center’s Leaning In webinar: Study Conduct (Recruitment, Retention). Our moderators included RADM Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) and MRCT Center Program Manager Laura Meloney, MSc, MPH. Guest speakers were Quita Beeler Highsmith, MBA, Vice President and Chief Diversity Officer at Genentech, and Anne Marie Inglis, PhD, Senior Director, Global Development Operations at Mallinckrodt.
Discussion Topic: The MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data held on February 10, 2021 from 11am – 12noon ET. Our moderators were MRCT Center Faculty Director, Barbara Bierer, MD and Luther Clark, MD, FACC, FACP, Deputy Chief Patient Officer at Merck. Our guest speakers will be Nicole Richie, PhD, Global Head, Health Equity and Population Science at Genentech Roche and Latha Palaniappan, MD, MS, Professor of Medicine at Stanford University School of Medicine. cs
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.
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 1
SESSION 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
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.
Each keynote speaker was followed by two moderated panel discussions to:
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.
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 1
SESSION 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
Keynote speakers A youth guest speaker: Rohit Keynote speaker: Dr. Sandhya Kanaka Yatirajula, Senior Research Fellow, The George Institute for Global Health, India
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 1
SESSION 2
June 28, 2022 (9-11 AM EDT)
Keynote speakers Dr. Dylan Graetz & Dr. Victor Santana, St. Jude’s Hospital, USA
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.
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.
The fifth and final part of the FDA-supported virtual conference series on Advancing International Pediatric Clinical Research showcased select resources and materials from the larger body of work developed by the MRCT Center pediatric working group initiative, including highlights from the four prior webinars in this series.
Presented at: Advancing International Pediatric Clinical Research webinar series: Facilitating Pediatric Medicines Development: Models of Global Cooperation
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.
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.
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.
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.
