Public Comments
Comments provided on: July 20, 2020
Comments provided to: Food and Drug Administration (FDA)
Focus Area: Clinical Trials & Research
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)
Mark Barnes co-authors a special report in New England Journal of Medicine
Mark Barnes, MRCT Center Faculty Co-Director co-authored a special report in New England Journal of Medicine “Challenges of “Return to Work” in an Ongoing Pandemic.”
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
Advancing Health Literacy in Clinical Research: Clear Communications for Every Participant
In Science Magazine, Dr. Barbara Bierer describes the COVID-19 Collaboration Platform.
In Science Magazine, MRCT Center Faculty Director Barbara Bierer along with her COVID-19 Collaboration Platform colleagues details the need for a home for clinical trial protocols that are available for collaboration.
“To increase the power of RCTs, we have created a pilot repository for RCT protocols led by principal investigators who are open to various levels of collaboration. On the COVID-19 Collaboration Platform (CovidCP.org), researchers can submit their draft or completed protocols and find collaborators.
Issues in the registration of database studies
Publication
Published on: January 20, 2020
Published in: Journal of Clinical Epidemiology
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
Partnering with Patients and Participants to Develop Clinical Research Materials and Plain Language Summaries
Presentation
Presented on: January 24, 2020
Presented by: Sylvia Baedorf Kassis
Presented at: CBI conference on Clinical Data Disclosure, Transparency and Plain Language Summaries