ASH Clinical News spoke with MRCT Center Faculty Director, Dr. Bierer about the lack of inclusivity in clinical trials, its implications, and efforts to strengthen the applicability of clinical trial results.
Focus Area: Clinical Trials & Research
Pediatric engagement in research: Young people have a voice
Presentation
Released on: June 29, 2021
Presented at: DIA 2021 Global Annual Meeting (Virtual)
MRCT Center Driving Inclusion in Clinical Research webinar: Improving Inclusion of Persons with Disabilities in Clinical Research
Webinar / Presentation
Webinar: June 9, 2021, 11:00 AM.-12 noon. EDT.
Discussion Topic: MRCT Center Driving Inclusion in Clinical Research webinar: Improving Inclusion of Persons with Disabilities in Clinical Research
Moderated by MRCT Center Faculty Director, Barbara Bierer, with guest speakers:
- Tinamarie Duff, Global Lead: People and Business Resource Group for DAWN (Differently-Abled Workplace Network) at Bristol Myers Squibb
- Julie Sowash, Executive Director, Disability Solutions; Co-Host, Crazy and The King Podcast; DEIB Lead, Ability Beyond
- Michael Stein, Professor; Executive Director, Harvard Law School Project on Disability
Webinar
Presentation Slides
MRCT Center Driving Inclusion in Clinical Research webinar: Inducement or Fair Compensation? Impact on Diverse Participation
Webinar Presentation
Webinar: May 12, 2021, 11:00 AM.-12 noon. EDT.
Discussion Topic: The MRCT Center Driving Inclusion in Clinical Research webinar: Inducement or Fair Compensation? Impact on Diverse Participation.
Moderated by MRCT Center Faculty Director, Barbara Bierer, MD and with guest speakers:
- Luke Gelinas, PhD, Senior Advisor at the MRCT Center and Chairperson at Advarra IRB
- Melissa Gonzales, PhD, Inclusion Principal, External Partnering in the Chief Diversity Office at Genentech
- J. Leonard Lichtenfeld, MD, MACP, Medical Oncologist and former Deputy Chief Medical Officer for the American Cancer Society
- Joseph Liss, JD, Associate at Ropes & Gray, LLP
Webinar
Presentation Slides
Applying Health Literacy Principles to Clinical Research Studies: A Three-part Health Literacy Training
In the Spring of 2021, Sylvia Baedorf Kassis, MPH, Program Manager, facilitated a successful three-part virtual training entitled “Applying Health Literacy Principles to Clinical Research Studies” for clinical research professionals across the University of Utah.
The training covered:
- Health Literacy 101: The focus of this session was on the ethics/principles of health literacy as applied to the entire clinical research life cycle, including an introduction to co-developing materials with participants.
- Health Literacy in Action: The focus of this session was to expand on health literacy introduction to give specific examples of health literacy best practices applied to different types of research, including interventional and socio-behavioral studies. This session also included information on integrating participant feedback into the development and materials at various points across the clinical research life cycle (e.g., recruitment flyers, consent process, study questionnaires, study instructions, processes for pediatric studies, end of study communications).
- Health Literacy and Returning Research Results: This session focused specifically on managing and sharing aggregate research results (i.e. plain language summaries) with study participants and the community. Considerations for individual return of results were also introduced.
MRCT Center Driving Inclusion in Clinical Research webinar: How to Begin
Webinar Presentation
Webinar: April 14, 2021, 11:00 AM.-12 noon. EDT.
Discussion Topic: The MRCT Center Driving Inclusion in Clinical Research webinar: How to Begin. Moderated by MRCT Center Faculty Director, Barbara Bierer, MD. Our guest speakers were Anya Harry, MD, PhD, Head, Global Demographics & Diversity at GlaxoSmithKline and Christopher Romero, MD, PhD, FACP, Medical Director, USA, at PanAmerican Clinical Research.
Webinar
Presentation Slides
Role of Real World Evidence and ICH-E17: A provocative perspective
MRCT Center in Science Magazine: “Justice, diversity, and research ethics review”
Published in Science Magazine “Justice, diversity, and research ethics review: It is time for institutional review boards and research ethics committees to address the ethics of inclusion” by MRCT Center Faculty Director Barbara Bierer, Executive Director Sarah White and Senior Advisor David Strauss.
Rare Inspiration. Changing Lives: Sarah White is part of an Alexion panel honoring Rare Disease Day
Presentation
Presented on: February 28, 2021
Presented at: “Rare Inspiration. Changing Lives” an Alexion discussion to honor Rare Disease Day 2021
Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses
Presentation
Presented on: February 16-17, 2021
Published in: FDA/Duke Margolis Center Virtual Workshop
