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.
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.
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.
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.
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.”
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.
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
