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: December, 2018
Published in: Journal of Clinical and Translational Science
Presented on: March 21, 2023
Presented at: MRCT Center Webinar series, Advancing International Pediatric Clinical Research: Time to Listen—Hearing from young people in clinical research
Description: Dr. Gianna “Gigi” McMillan, an academic bioethicist and MRCT Center pediatrics project member, recorded in-depth interviews with three young people from India, Spain, and the US to create this 2-part video series, Time to Listen.
Part 2: Young people respond after watching adults discuss the goal of elevating their perspective at an international webinar.
Themes:
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.
Published on: March 21, 2023
Description: The “Including Young People in Research” toolkit offers tools, checklists, and considerations to support the intentional inclusion of the youth perspective in pediatric clinical trials and product development. These materials can assist investigators, Institutional Review Boards (IRBs)/Ethics Committees (ECs), sponsors, and others working with children and adolescents to engage youth respectfully and thoughtfully, helping to ensure that their perspectives are valued, gathered, appropriately weighted, and integrated. We expect that individuals will adapt these tools to their local context and specific study needs. We invite you to watch our short companion video for additional details on how to use and adapt these tools.
Tools, checklists, and considerations to assist investigators, Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and those working with children and adolescents to thoughtfully engage youth and ensure their perspectives are valued, weighted, and integrated.
Promoting Global Clinical Research in Children: Informing the Future (webinar)
Promoting Global Clinical Research in Children: Informing the Future (presentation slides)
Guiding Principles for Protecting Children in and through Pediatric Clinical Research
Advancing International Pediatric Clinical Research webinar series
Pediatric Research Information Materials
Prioritizing Young People’s Voices in Clinical Research – Part 1 (video)
Prioritizing Young People’s Voices in Clinical Research – Part 2 (video)
Prioritizing Young People’s Voices in Clinical Research – Part 3 (video)
Time to Listen: Hearing from Young People in Clinical Research – Part 1 (video)
Time to Listen: Hearing from Young People in Clinical Research – Part 2 (video)
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.
The MRCT Center presented a five-part virtual conference series, Advancing International Pediatric Clinical Research, to advance the design, review, oversight, and conduct of global pediatric clinical trials. These videos, shared in the webinars, were produced in collaboration with the International Children’s Advisory Network (iCAN.)
iCAN, in collaboration with the MRCT Center, produced a three-part video series that showcases young people from around the globe who have been involved in medical care and clinical research. The youth in the videos share some their thoughts on various aspects of what is important about including and listening to young people in clinical research.
Dr. Gianna ‘Gigi’ McMillan, an academic bioethicist and member of the MRCT Center pediatrics project, recorded in-depth interviews with three young people from India, Spain, and the US to create this 2-part video series, Time to Listen. In part 1, young people share their experience in clinical research and best practice guidance on communicating and conveying information to children and adolescents. Part 2 shows young people’s responses after watching adults discuss the goal of elevating their perspective at an international webinar.
