Publication
Published on: August 6, 2020
Published in: Healthcare: The Journal of Delivery Science and Innovation
Language: English
Diversity, Inclusion, and Equity In Clinical Research: Diversity Principles And Suppositions
Framework
Developed on: August 2020
Developed by: MRCT Center Diversity Workgroup
The MRCT Center Diversity Workgroup has developed a set of fundamental principles that help to frame considerations of diverse representation in clinical research. While we recognize that a case-based analysis will be required for each clinical research question, we also believe that these principles will help guide those analyses.
Action for Change: Diversity, Inclusion, and Equity in Clinical Research.
Framework: Action For Change
Developed on: August 2020
Developed by: MRCT Center Diversity Workgroup
There are practical and operational barriers that prevent routine participation of underrepresented, underserved, and diverse populations in clinical research. These must be addressed to promote change. While many challenges exist, for each section, we provide a key summary and recommendations to address appropriate representation in clinical research. Link to Resource >
Response to the FDA’s RFI on Rare Disease Clinical Trial Networks, supporting the Rare Disease Cures Accelerator
Public Comments
Comments provided on: July 20, 2020
Comments provided to: Food and Drug Administration (FDA)
Response to FDA’s request for comments on strategic priorities for the Office of Minority Health and Health Equity (OMHHE)
Public Comments
Comments provided on: June 29, 2020
Comments provided to: Food and Drug Administration (FDA)
Observational Patient Evidence for Regulatory Approval and understanding Disease (OPERAND)
Presentation
Presented on: June 18, 2020
Presented by: Barbara E. Bierer, MD
Presented at: DIA 2020 Virtual Global Annual Meeting
Communicate and co-create with patients across the medicines development lifecycle: Principles and best practices
Presentation
Presented on: June 18, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: DIA 2020 Virtual Global Annual Meeting
Issues in the registration of database studies
Publication
Published on: January 20, 2020
Published in: Journal of Clinical Epidemiology
Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)
Public Comments
Comments provided on: April 29, 2020
Comments provided to : European Commission
Writing and Design Workshop for Research and Practice
Presentation / Video
Presented on: April 17, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: Tufts University School of Medicine Plain Language Workshop