The Joint Task Force for Clinical Trial Competency (JTF) is an international team of investigators, educators and clinical research professionals that has developed a framework that defines the knowledge, skills and attitudes necessary for conducting safe, ethical and high-quality clinical research.
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.
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.
Each keynote speaker was followed by two moderated panel discussions to:
This project is supported by the FDA (R13) Scientific Conference Grant Program.
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 |
Each keynote speaker was followed by:
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.
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 |
Each keynote speaker was followed by:
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.
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 |
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.
📄 Agenda and Bio Book
🎥 Watch webinar recording
⬇️ Download webinar slides
Published on: December, 2018
Published in: Journal of Clinical and Translational Science
Released on: December 6, 2017
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Released on: December 6, 2017
Developed by: MRCT Center Post-Trial Responsibilities Workgroup
Date: March 30, 2023
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 will be included as a CDISC standard starting in 2023 and will go through a public review process. This helpful video explains how to submit public comments to JIRA, a software application that tracks comments in an organized way.
Click here to complete the January 12, 2024 public review.
Click here to read more about our collaboration with CDISC to expand access to the MRCT Center’s Clinical Research Glossary.
Date: March 21, 2023
A “how-to” video to support the Including Young People in Clinical Research toolkit. These tools, checklists, and considerations are offered to assist investigators, Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and those working with children and adolescents to engage youth respectfully and thoughtfully.
Comments provided on: March 8, 2023
Comments provided to: Food and Drug Administration re: Docket No. FDA-2020-N-0258
Published on: March 29, 2023
Published in: Patterns
Description: Dr. Barbara Bierer, MRCT Center Faculty Director, and Laura Meloney collaborated with Ariel Carmeli, a graduate student at Harvard Medical School Department of Biomedical Informatics and Harvard Business School, to develop a dynamic data visualization tool. The tool allows users to explore demographic representation in clinical trials associated with 339 FDA drug and biologic approvals from 2015-2021, using data from FDA Drug Trials Snapshots. The tool can help organizations improve trial representation and enhance health equity by providing information on trial representation over time, according to race, ethnicity, age, and sex, across therapeutic areas and pharmaceutical sponsors. A co-authored article about the tool, “Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products,” was published in Cell Patterns.
