Webinar
Published on: October 14, 2020 – July 14, 2021
Check out webinar recordings and slides.
MRCT Center Leaning In Webinar Series
Resource Type: Webinar
Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations
Goals:
- Gain a common understanding on the desired goals of subgroup analyses
- Establish standards for assessing effects within subgroups and for defining meaningful differences in effect between subgroups
- Review the characteristics, assumptions, advantages and limitations of traditional and innovative models for subgroup analyses
- Review contribution of data visualization techniques to complement and enhance statistical modeling approaches and interpretation
- Develop and communicate recommendations
🎥 Watch the webinar recording:
Day 1: Monday, November 30, 2020
| TIME | PROPOSED AGENDA | PROPOSED SPEAKERS |
| 8:30-8:45 | Welcome Opening remarks (MRCT Center) | Richardae Araojo Sylva Collins Barbara Bierer |
| 8:45-9:10 | Keynote speaker: A clinical trialist’s perspective “System Redesign needed to make sense of findings that suggest heterogeneity of treatment effect” | Robert Califf |
| 9:10-10:15 | Challenges for the Regulator, Clinician, and Patient: Population safety and efficacy but individual treatment Moderator: David Strauss | Christopher Granger Ellis Unger Janet Wittes Donna Cryer Danielle Campbell Aloka Chakravarty |
| 10:15-10:30 | Break | |
| 10:30-11:00 | Goals of subgroup analyses, assessing standards for analysis of differences, and limits of interpretation | Steven Snapinn |
| 11:00-11:30 | Subgroup identification: Utility, impact, and methods | Scott Evans |
| 11:30-12:45 | Statistical Methods I Moderator: Li Chen | Stuart Pocock Stephen Ruberg Lisa Lavange Mark Rothmann Kathleen Fritsch Ravi Varadhan |
| 12:45-12:50 | Closing remarks | Richardae Araojo and Barbara Bierer |
Day 2: Tuesday, December 1, 2020
| Time | Proposed Agenda | Proposed Speakers |
| 8:30-9:30 | Statistical Methods II Moderator : Steve Snapinn | Donald Berry Thomas Louis Gene Pennello Frank Bretz |
| 9:30- 10:00 | Summary Discussion of Statistical Methods I and II | |
| 10:00-10:15 | Break | |
| 10:15-11:15 | Data Visualization and the role of graphical representation Moderator: Marcia Levenstein | Frank Harrell Ilya Lipkovich Michael Griswold |
| 11:15-12:15 | Panel: Statistical methodologies, pros and cons Moderator: Thomas Gwise | Frank Rockhold Qi Jiang Thomas Gwise John Scott |
| 12:15-12:45 | Open discussion and Conclusions | FDA and MRCT Center |
| 12:45- 1:00 | Core team to discuss Day 1 & Day 2 wrap up | Planning committee |
A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration
Webinar
Date: April 5, 2023
A discussion about the MRCT Center’s collaboration with CDISC to promote the MRCT Center’s Clinical Research Glossary, a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers, as a global research standard.
Learn about the MRCT Center’s robust process of developing the plain language glossary, the CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Related Resources:
Presentation Slides
Audience Q&A
Speaker Bios
Link to Public Review Website
Helpful Video Tutorial about how to submit a Public Comment
Link to a Public Review Outreach Template
Accessibility by Design (AbD) Toolkit Release
Webinar
Date: May 4th, 2023
Description: Learn about the Accessibility by Design (AbD) in Clinical Research Toolkit, developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
We present the background, structure, and key themes of the AbD Toolkit. Invited speakers then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.
Webinar
Related Resources:
Accessibility by Design (AbD) Toolkit
Integrating Supported Decision-Making into the Clinical Research Process (Publication)
MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)
PRIM&R WEBINAR: “THE IRB’S ROLE IN ACHIEVING DIVERSITY IN RESEARCH”
Webinar
Webinar: November 10, 2020, 1pm-2:30pm ET.
Discussion Topic: MRCT Center Faculty Director, Dr. Barbara Bierer, MRCT Center Executive Director, Sarah A. White, MPH and MRCT Center Senior Advisor David Strauss, MD discussing “The IRB’s Role in Achieving Diversity in Research” at the PRIM&R webinar “”The IRB’s Role in Achieving Diversity in Research.”
MRCT Center Leaning In webinar: Study Conduct (Recruitment, Retention)
Webinar
Webinar: December 9, 2020, 11:00 AM.-12 noon. ET.
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.
Webinar
Related Resources
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical Research
MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data
Webinar
Date: February 10, 2021, 11:00 AM-12 noon. ET.
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
Webinar
Related Resources
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical Research
MRCT Center Leaning In webinar: Data Standards and Analysis
Webinar
Presented on: January 13, 2021
Presented at: MRCT Center Leaning In Webinar Seriess
Webinar
Related Resources
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical 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.
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 📄 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:
- 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 📄 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 1 | SESSION 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 1 | PART 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: Promoting Global Clinical Research in Children: Informing the Future
Webinar
Presented on: March 21, 2023
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.
