The Convergence Project is pleased to invite you to an upcoming virtual event hosted by the MRCT Center, focused on workforce development strategies to support a more dynamic and competitive clinical research workforce.
This meeting will bring together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics will include workforce development, targeted recruitment, and actionable steps to drive systemic improvements. You’ll have the opportunity to engage with panelists leading programs in Georgia, North Carolina, West Virginia, and other states across the country.
We hope you can join us for this important conversation. We look forward to your participation!
Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series.
Key Topics:
Why and How Long-Term Follow-up (LTFU) studies are conducted for Gene therapies
Ethical, Regulatory, and Operational Challenges of LTFU studies
Maximizing the value and minimizing the burden of LTFU studies
We invite you to attend the next virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) to learn about, present updates, and coordinate ongoing activities with the JTF Framework.
Agenda Highlights:
· Launch of a participant and patient partner competencies task force.
· Delphi results from the Data Management Task Force.
· Proposed team science competencies.
· Updates on the Portuguese translation of JTF resources.
· Results from the JTF competency survey conducted in the Philippines.
· Training community workers using the JTF framework.
Description: On Thursday, September 19, 2024, the MRCT Center and Ropes & Gray will be co-presenting a webinar to review significant changes to the federal research misconduct regulations outlined in the highly anticipated Final Rule, issued on September 12, 2024, by the U.S. Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”). Ropes & Gray has prepared a redline of the changes against the current regulations (available here) and a redline of the changes against the proposed rule (available here).
The Final Rule outlines changes to the federal research misconduct regulations set forth at 42 C.F.R. Part 93 (“Part 93”). Part 93 sets forth the federal regulatory framework that must be followed for investigating allegations of research misconduct (falsification, fabrication, or plagiarism) pertaining to research in which U.S. Public Health Service funds—including NIH funds—have been provided. The changes outlined under the Final Rule are extensive and highly impactful and include significant changes from the proposed rule that was published by ORI in October 2023. By way of example, the Final Rule omits a provision in the proposed rule that would have prohibited institutions from reaching an “honest error” finding at an early stage of a research misconduct proceeding. These changes will require institutions to implement significant changes to their existing policies and practices for reviewing allegations of misconduct. The Final Rule provides that institutions must implement these changes by January 1, 2026.
For a detailed discussion of the key changes in the Final Rule, we invite you to attend our webinar on Thursday, September 19, 2024. MRCT Center Faculty Director Barbara Bierer and Ropes & Gray presenters, including Mark Barnes, co-founder and Faculty co-Director of the MRCT Center, will be joined by The University of Texas MD Anderson Cancer Center’s Madhu Purewal, Senior Legal Officer & Executive Director, Research Compliance, who will offer perspective during the question and answer portion of the webinar on the significance of the rule changes from the perspective of a large academic research institution.
November 14, 2024
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November 15, 2024
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JOIN US! MRCT Center 2024 Annual Symposium
The MRCT Center is proud to invite clinical research stakeholders—including professionals, patient participants, and advocates—to the 2024 Annual Symposium, a complimentary event celebrating 15 years of advancing ethical, actionable, and practical solutions for clinical trials. This symposium will bring together diverse voices to explore cutting-edge advancements, regulatory updates, and participant-centered approaches shaping the future of clinical research.
Event Details:
Date: November 14–15, 2024
Location: Gordon Hall & Countway Library, Harvard Medical School, Boston, MA. A virtual option is also available.
Cost: Free to all registrants
Featured Keynote:
We are honored to welcome Dr. Khair ElZarrad, Director, Office of Medical Policy, FDA, as our keynote speaker. Dr. ElZarrad will share perspectives on current trends and future developments in clinical research and regulation.
Highlighted Panels:
Panel 1: Post-trial, Continued Access to Investigational Medicines and Devices
This panel will address the complexities of ensuring post-trial access to investigational interventions, spotlighting practical solutions and ongoing challenges.
Panel 2: Expanding the Uses of Data and AI in Support of Clinical Trials
Explore how AI-driven digital twins are transforming the landscape of clinical trials by creating virtual simulations of patient outcomes. This session will cover the technical, ethical, and practical considerations of this game-changing technology.
Panel 3, Breakout 2: A Conversation with Participant Advocates: The Future of Participant-Centered Clinical Research
Participant/advocates will share their personal experiences and discuss how participant-centered clinical research can better address participant needs.
Panel 4: Accessibility in Decentralized Trials
This panel will focus on the importance of inclusive trial design, emphasizing how decentralized trial components can be made accessible to all participants, particularly those with disabilities, through universal design principles.
Additional Highlights:
Networking opportunities, including lunch and a cocktail reception
Vivli/MRCT Center Annual Meeting on Friday, November 15: Symposium registrants are invited to join the Annual Meeting at the Harvard Faculty Club, which will include:
Keynote by Steffen Thirstrup, CMO, European Medicines Agency, on the future of data sharing and the European Health Data Space
Panel Discussions on data sharing, Health Information Exchanges (HIE), and the opportunities and risks of AI in clinical research
Help advance solutions that lead to meaningful change in clinical trials and ultimately improve patient outcomes. Join us in Boston to help foster collaboration and drive the implementation of strategies that deliver tangible results for both patients and the wider research community.
To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools for incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
The Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
Description: Join the REACH collaborative for a dynamic webinar focused on improving PowerPoint presentations through clear, accessible, and inclusive considerations. This session will begin by continuing the discussion from the first two October 2024 MRCT Center webinars on developing impactful and empowering participant-facing materials (such as Informed Consent forms) and utilizing plain language. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how these health literacy principles congruently apply from a disability perspective. Because so much communication is now virtual, we’ll then move to exploring how to make PowerPoint content not only readable and approachable, but also formatted for accessibility and inclusiveness of people with disabilities. Whether you’re a researcher, HRPP, or involved in other areas of clinical research, this webinar will provide valuable insights into creating presentations that are both accessible and engaging.
Key Topics:
Learn about the core concepts of health literacy and why they matter in clinical research. Understand how these principles can improve the clarity of your presentations.
Explore hands-on approaches for integrating readability and health literacy principles into your PowerPoint slides.
Participate in a moderated discussion and Q&A session to delve deeper into the application of plain language and readability in presentations. Share your experiences and get answers to your questions.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
Description: Join the MRCT Center for this webinar that will feature experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Paula Steeves, Lead Patient Advocate, Breast Oncology, Dana-Farber Cancer Institute, and Timothy Erick, Science Writer, Dana-Farber Cancer Institute.
Please join us as we discuss:
The core elements of creating and disseminating Plain Language Summaries.
What results to return, who to involve in the creation process, and how to approach dissemination.
How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.
To celebrate Health Literacy Month this October, the MRCT Center invites you to participate in three engaging and informative webinars. These sessions will provide practical tools and foster robust discussions, benefiting anyone interested in incorporating health literacy and accessibility best practices into communicating participant-facing clinical research information.
Description: This informative webinar will leverage experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.
The moderator, Sylvia Baedorf Kassis, will join the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program.
Implementing a participant-centric approach, utilizing the Clinical Research Glossary, and integrating innovative elements into the consent process.
Participate in a moderated discussion and Q&A session to delve deeper into ways to enhance the informed consent process. Share your experiences and get answers to your questions.
We look forward to sharing this important work with you.
The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024
People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.
This webinar featured two interactive exercises in which participants learned:
Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.
More about REACH: Research Ethics Action Collaborative for HRPPs (REACH) is an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Click here to learn more.
The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
Practical implementation examples and areas that require further research and guidance.
Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
Hafeez H et al. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017;9:e1184. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/
Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (2011). The health of lesbian, gay, bisexual, and transgender people. National Academies Press (US). Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK64806/
Landers SJ et al. Sexual Orientation Differences in Asthma Correlates in a Population-Based Sample of Adults. Am J Public Health. 2011:101:2233-2244. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222437/
Fredriksen-Goldsen KI et al. Health and Access to Care and Coverage for Lesbian, Gay, Bisexual, and Transgender Individuals in the U.S. Am J Public Health. 2017:107:1332-1338. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508186/
Hughes LD et al. Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance. Demography. 2022;59:1023-1043. Accessed August 30, 2023. https://doi.org/10.1215/00703370-9942002
Morris M et al. Training to reduce LGBTQ-related bias among medical, nursing, and dental students and providers: a systematic review. BMC Medical Education. 2019;19:325. Accessed August 30, 2023. https://doi.org/10.1186/s12909-019-1727-3
Dahlhamer JM et al. Barriers to Health Care Among Adults Identifying as Sexual Minorities: A US National Study. Am J Public Health. 2016;106:1116. Accessed August 29, 2023. https://doi.org/10.2105/AJPH.2016.303049
Sterling J et al. Cancer screening in the transgender population: a review of current guidelines, best practices, and a proposed care mode. Transl Androl Urol. 2020;9(6):2771-2785. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807311/
Cahill S et al. Do Ask, Do Tell: High Levels of Acceptability by Patients of Routine Collection of Sexual Orientation and Gender Identity Data in Four Diverse American Community Health Centers. PLoS ONE. 2014;9:e107104. Accessed August 7, 2023. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0107104
Daniel H et al. Lesbian, Gay, Bisexual, and Transgender Health Disparities: Executive Summary of a Policy Position Paper From the American College of Physicians. Ann Intern Med. 2015;163:135-137. Accessed August 7, 2023. https://doi.org/10.7326/M14-2482
Badgett MVL. (2009). Best Practices for Asking Questions about Sexual Orientation on Survey. Los Angeles: The Williams Institute. Accessed August 7, 2023. https://escholarship.org/uc/item/706057d5
Spade D. Normal Life: Administrative Violence, Critical Trans Politics, and the Limits of Law. Durham, NC: Duke University Press; 2015.
Brown I, McKenzie M, Srirangam A, Patel S. Making an Inclusive Impact: LGBTQ+ Health Equity in Clinical Trials. Poster presented at Drug Information Association Global Annual Meeting: June 25-29, 2023; Boston, MA.
Data on File. Genentech, Inc. South San Francisco, CA.