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Time to Listen: Hearing from Young People in Clinical Research – PART 2

Video

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:

  • recognizing the power imbalance
  • validating young people’s opinions
  • creating a “safe space” to share
  • reiterating the importance of young people in clinical research.
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Data visualization explorer: A tool for participant representation

Publication

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.

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Including Young People in Research

Tools

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.

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View Video Resource

Including Young People in Clinical Research – PDF

2023-12-07 Peds Toolkit v4.1 (1)

Including Young People in Clinical Research – A “How-to” Guide

Related Resources

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)