Framework
Developed in: March 2015
Developed by: MRCT Center Post-Trial Responsibilities Working Group
Language: English
Ethical Considerations for Clinical Investigations of Medical Products involving Children: Guidance for Industry, Sponsors, and IRBs
Public Comment
Comments provided on: December 20, 2022
Comments provided to: Food and Drug Administration re: Docket No. FDA-2022-D-0738
Dr. Bierer discusses Diversity in Clinical Research on the Clinical Trials Guru podcast
Podcast
Achieving Diversity, Inclusion, and Equity in Clinical Research A link to the guidance document: https://mrctcenter.org/diversity-in-clinical-research/
Joint Task Force for Clinical Trial Competency Website
Project-Specific Website
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.
Returning Aggregate Results of Clinical Trials
Publication
Published on: December, 2018
Published in: Journal of Clinical and Translational Science
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.
Guiding Principles for Protecting Children in and through Pediatric Clinical Research
Including Young People in Clinical Research Toolkit Companion
Video
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.
Investigational New Drug Application Annual Reporting; A Proposed Rule
Public Comments / Sponsor Resource
Comments provided on: March 8, 2023
Comments provided to: Food and Drug Administration re: Docket No. FDA-2020-N-0258
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.