Presented on: July 27, 2023
Return of Individual Results Case Studies
Case Study: Implementing a Robust, Scalable Participant Data Return Solution
Return of Individual Research Results website
Presented on: June 20, 2023
Presented at: Virtual
Description: The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs) and presented a joint webinar titled “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20, 2023.
During the webinar, Dr. Barbara Bierer (MRCT Center) and Dr. Pam Tenaerts and Leanne Madre (Medable) presented guidance and tools organized around 12 key elements. 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 the necessary framework, tools, and recommendations for conducting ethical reviews. Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.
Date: May 2, 2023
Description: Since the updated Individual Return of Results toolkit was released last year, the MRCT Center has continued collaborating with leaders from academia, patient advocacy groups, and industry to create a series of case studies. These cases detail the experiences of five organizations planning and implementing procedures to return individual research results and data to participants, highlighting ethical, scientific, operational, regulatory, and technical considerations that should be considered. In this webinar, case study authors shared their experiences, successes, and challenges in a moderated conversation.
Published on: October 14, 2020 – July 14, 2021
Check out webinar recordings and slides.
Goals:
🎥 Watch the webinar recording:
| TIME | PROPOSED AGENDA | PROPOSED SPEAKERS |
| 8:30-8:45 | Welcome Opening remarks (MRCT Center) | Richardae Araojo Sylva Collins Barbara Bierer |
| 8:45-9:10 | Keynote speaker: A clinical trialist’s perspective “System Redesign needed to make sense of findings that suggest heterogeneity of treatment effect” | Robert Califf |
| 9:10-10:15 | Challenges for the Regulator, Clinician, and Patient: Population safety and efficacy but individual treatment Moderator: David Strauss | Christopher Granger Ellis Unger Janet Wittes Donna Cryer Danielle Campbell Aloka Chakravarty |
| 10:15-10:30 | Break | |
| 10:30-11:00 | Goals of subgroup analyses, assessing standards for analysis of differences, and limits of interpretation | Steven Snapinn |
| 11:00-11:30 | Subgroup identification: Utility, impact, and methods | Scott Evans |
| 11:30-12:45 | Statistical Methods I Moderator: Li Chen | Stuart Pocock Stephen Ruberg Lisa Lavange Mark Rothmann Kathleen Fritsch Ravi Varadhan |
| 12:45-12:50 | Closing remarks | Richardae Araojo and Barbara Bierer |
| Time | Proposed Agenda | Proposed Speakers |
| 8:30-9:30 | Statistical Methods II Moderator : Steve Snapinn | Donald Berry Thomas Louis Gene Pennello Frank Bretz |
| 9:30- 10:00 | Summary Discussion of Statistical Methods I and II | |
| 10:00-10:15 | Break | |
| 10:15-11:15 | Data Visualization and the role of graphical representation Moderator: Marcia Levenstein | Frank Harrell Ilya Lipkovich Michael Griswold |
| 11:15-12:15 | Panel: Statistical methodologies, pros and cons Moderator: Thomas Gwise | Frank Rockhold Qi Jiang Thomas Gwise John Scott |
| 12:15-12:45 | Open discussion and Conclusions | FDA and MRCT Center |
| 12:45- 1:00 | Core team to discuss Day 1 & Day 2 wrap up | Planning committee |
Date: April 5, 2023
A discussion about the MRCT Center’s collaboration with CDISC to promote the MRCT Center’s Clinical Research Glossary, a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers, as a global research standard.
Learn about the MRCT Center’s robust process of developing the plain language glossary, the CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Related Resources:
Presentation Slides
Audience Q&A
Speaker Bios
Link to Public Review Website
Helpful Video Tutorial about how to submit a Public Comment
Link to a Public Review Outreach Template
Date: May 4th, 2023
Description: Learn about the Accessibility by Design (AbD) in Clinical Research Toolkit, developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
We present the background, structure, and key themes of the AbD Toolkit. Invited speakers then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.
Related Resources:
Accessibility by Design (AbD) Toolkit
Integrating Supported Decision-Making into the Clinical Research Process (Publication)
MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)
Webinar: November 10, 2020, 1pm-2:30pm ET.
Discussion Topic: MRCT Center Faculty Director, Dr. Barbara Bierer, MRCT Center Executive Director, Sarah A. White, MPH and MRCT Center Senior Advisor David Strauss, MD discussing “The IRB’s Role in Achieving Diversity in Research” at the PRIM&R webinar “”The IRB’s Role in Achieving Diversity in Research.”
Webinar: December 9, 2020, 11:00 AM.-12 noon. ET.
Discussion Topic: MRCT Center’s Leaning In webinar: Study Conduct (Recruitment, Retention). Our moderators included RADM Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) and MRCT Center Program Manager Laura Meloney, MSc, MPH. Guest speakers were Quita Beeler Highsmith, MBA, Vice President and Chief Diversity Officer at Genentech, and Anne Marie Inglis, PhD, Senior Director, Global Development Operations at Mallinckrodt.
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical Research
Date: February 10, 2021, 11:00 AM-12 noon. ET.
Discussion Topic: The MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data held on February 10, 2021 from 11am – 12noon ET. Our moderators were MRCT Center Faculty Director, Barbara Bierer, MD and Luther Clark, MD, FACC, FACP, Deputy Chief Patient Officer at Merck. Our guest speakers will be Nicole Richie, PhD, Global Head, Health Equity and Population Science at Genentech Roche and Latha Palaniappan, MD, MS, Professor of Medicine at Stanford University School of Medicine. cs
See related Webinars, maintained on our project specific Diversity, Inclusion, and Equity in Clinical Research website:
October 14, 2020: Community Awareness, Access, Knowledge
October 28, 2020: Workforce Development
November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility
December 9, 2020: Study Conduct (Recruitment, Retention)
January 13, 2021: Data Standards and Analysis
January 27, 2021: Stakeholder Roles and Responsibilities
May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation
June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research
July 14, 2021: Simplifying the Complexity of Translation in Clinical Research
