In the Spotlight
The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). Together, they presented a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20.
MRCT Center Faculty Director Dr. Barbara Bierer and Medable’s Dr. Pam Tenaerts and Leanne Madre presented guidance and tools organized around 12 key elements during the webinar. These elements are grouped into three domains: People, Remote Data Collection, and Data Oversight. The aim is to provide IRBs, ethics committees (ECs), and sponsors with a framework, tools, recommendations, and best practices for conducting ethical review. Advarra representative Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.
For more about the IRB/EC Considerations for DCT Review, click here.
Click here to view the webinar resources, including the recording and presentation slides.
Return of Individual Research Results and Data: Digging Deeper Webinar Series
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar.
Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning related to returning individual results.
The series will feature conversations with Pfizer, Yale University, and the National Cancer Institute representatives. Please register for one, two, or all by clicking the links below.
Session 1: Pfizer’s Participant Data Return Solution
Thursday, July 27, 12 – 1:00 PM ET: Paula Boyles, Pfizer, Inc
Session 2: IRB and HRPP Responsibilities
Thursday, August 17, 12 – 1:00 PM ET: Linda Coleman and Madelon Baranoski, Yale University
Session 3: Genetic Testing
Thursday, September 21, 12 – 1:00 PM ET: Megan Frone, National Cancer Institute
Joint Task Force for Clinical Trial Competency (JTF) News
The MRCT Center hosted a biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) on May 2. The meeting included updates from various members of the JTF and progress reports from workgroups, including Data Management and Informatics, Assessment, and Emergency Preparedness.
Click here to read the meeting summary.
The next biannual global meeting has been scheduled for November 14, 2023. To learn about or present updates and coordinate ongoing activities, please register here.
A Global Plain-Language Standard: MRCT Center Glossary Public Review
The MRCT Center continues to lead the co-creation of a plain-language clinical glossary. As a new CDISC global standard, the MRCT Center Clinical Research Glossary is being developed by a workgroup of dedicated volunteers, including patients, advocates, research professionals, medical writers, and others, to deliver understandable and valuable research information to a broad audience.
As part of the process, a CDISC public review period is currently open for 118 new words and definitions.
Here is the link to the public review package.
We have included a helpful video to guide you through submitting a review.
Please click here for more information about the MRCT Center glossary and our collaboration with CDISC to create a plain-language global standard.
Pediatric Brochures in Arabic
We are delighted to share that several pediatric educational brochures to explain aspects of clinical research have been translated into Arabic by our colleagues at the King Hussein Cancer Center in Amman, Jordan. We are grateful for this ongoing collaboration.
· What happens at the end of a Research Study?
Stay tuned for translations into additional languages! Please contact Lisa Koppelman at ekoppelman@bwh.harvard.edu if you are interested in partnering to translate and adapt these or any of our other pediatrics-focused materials.
Events & Presentations
June 21-22: The MRCT Center leadership hosted External Advisory Board and Executive Committee meetings in Cambridge, MA. These meetings focused on the MRCT Center’s strategic planning and vision of our work, which are critical steps in our efforts to develop innovative solutions and aligned approaches to global clinical research.
June 27 and 28: Faculty Director Dr. Barbara Bierer presented IRB/EC Considerations for Ethical Review and PI Oversight at the DIA conference in Boston.
June 28: Program Director, Sylvia Baedorf Kassis MPH, presented “Returning Individual Participant Data: A Cultural & Operational Shift Towards Personalized Clinical Trial Options” at the DIA conference in Boston.
July 27, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper
Session 1: Pfizer’s Participant Data Return Solution (see Spotlight above)
August 17, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper
Session 2: IRB and HRPP Responsibilities (see Spotlight above)
September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3)
Topic: Research Collaboration with China. Open to R3 Sponsors.
September 21, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper
Session 3: Genetic Testing (see Spotlight above)
Publications
May 25, 2023: MRCT Center Program Director Dr. Deborah Zarin co-authored an article, “Bringing data monitoring committee charters into the sunlight,” in Clinical Trials, addressing the lack of access to data monitoring committees (DMCs) charters and calling on the NIH to allow their voluntary upload into ClinicalTrials.gov.
June 2023: The MRCT Center’s work on IRB/EC considerations for DCT review with Medable, Inc. was cited in several publications:
· Biospace
· Applied Clinical Trials
· Contract Pharma
· Trial Site News
· Clinical Trials Arena
· Clinical Research News
· Clinical Trials Arena/INFORMA
Quotable Quote: June 7, 2023: MRCT Center Program Director Sylvia Baedorf Kassis was quoted in an article, “Patient Data Return: Do the Benefits Outweigh the Barriers?” in Applied Clinical Trials Online, speaking about the importance of returning individual results and data to Clinical trial participants.
MRCT Center Updates
The MRCT Center welcomes three new team members:
Alyssa Panton: Research Assistant
Alyssa will be primarily involved in the Center’s clinical research data literacy and AI work and is very interested in global
health ethics, health equity, and human subject protection and education.
Alyssa obtained her Master of Bioethics degree from Harvard Medical School and her Bachelor of Arts in the History of Science and Language from Harvard.
Yimeng (Anna) Lyu: Student Researcher, Creative Design
As a summer intern, Anna works on creative design and research for several MRCT Center projects, including the Clinical Research Glossary and Promoting Global Clinical Research in Children.
Anna is a senior at Tufts University, School of Museum Fine Arts, pursuing her Bachelor of Fine Arts (BFA) degree.
Xinyu (Sandra) Ye: Student Researcher, Creative Design
As a summer intern, Sandra works on creative design and research for several MRCT Center projects, including the Clinical Research Glossary and Promoting Global Clinical Research in Children.
Sandra is a junior at Vanderbilt University pursuing a Bachelor of Science in Cognitive Studies and Communication of Science and Technology.
