In the Spotlight
MRCT Center and CDISC Collaborate to Advance the Plain Language Clinical Research Glossary
We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) to promote the MRCT Center Clinical Research Glossary as a global clinical research standard. The MRCT Center Clinical Research Glossary is a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers. With this collaboration, the MRCT Center Clinical Research Glossary will be offered as a CDISC standard, helping sustain and expand its reach across the research enterprise. It will grow over time, increasingly helpful to participants and in participant-facing clinical research communications. As part of this collaboration, all plain language definitions in the MRCT Center Clinical Research Glossary will undergo CDISC’s public review process, which is now open through April 14.
Click here for a helpful video tutorial on how to submit comments.
Click here to submit comments.
Please join us on April 5 from 11 AM – 12 PM ET for a joint MRCT Center and CDISC webinar. Learn about MRCT Center’s robust process of developing the plain language glossary, CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Click here to register.
Release of Including Young People in Research toolkit
This toolkit is offered to assist investigators, sponsors, IRBs, and others in their support of the inclusion of young people as patient partners in clinical research and research-related activities. Only by inviting young people to the table will we help ensure that their perspectives are heard and valued.
Click here to view the Including Young People in Research toolkit, the “how-to” companion video, and related resources.
JTF Framework
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Bahasa Indonesia. Click here to view.
Other available translations: English, Spanish, French, Japanese, and Thai. Additional translations are in progress.
Translation in Bahasa Indonesia:
Terjemahan Bahasa Indonesia dari Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework kini tersedia!
Kami dengan senang hati mengumumkan bahwa Satuan Tugas Gabungan untuk Kompetensi Uji Coba Klinis (JTF) Kerangka Kerja Kompetensi Inti untuk Profesional Riset Klinis kini tersedia dalam Bahasa Indonesia. Klik di sini untuk melihat.
Pediatrics Webinar – Promoting Global Clinical Research in Children: Informing the Future
Last week’s Promoting Global Clinical Research in Children: Informing the Future webinar had over 400 registrants from 60 countries. The webinar was the fifth and final in an FDA-sponsored Scientific Conference Grant series: Advancing International Pediatric Clinical Research. In total, nearly 1500 people registered for the series from 83 countries.
To watch the webinar now, click here.
New Steering Committee Members
Headlands Research is an international integrated network of clinical trial sites with a focus on diversity, quality, and cutting-edge technology. Learn more about Headlands Research here.
Medable is the decentralized clinical trial platform with the most global experience. Learn more about Medable here.
Learn more about MRCT Center sponsors and sponsorship opportunities.
Events & Presentations
March 27
MRCT Center Faculty Director Dr. Barbara Bierer presented “Diversity, inclusion, and equity in clinical trials: The role of OBGYNs in ensuring diverse representation” at the American College of Osteopathic Obstetricians and Gynecologists (ACOOG).
March 30
MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky spoke on “Action and Accountability: Equity by Design” at the NIH Workshop on Inclusive Participation in Clinical Research.
April 5: 11 AM – 12 PM ET
“Announcing a Global Standard in Plain Language for Clinical Research: A Joint Webinar by the MRCT Center and CDISC.” (See Spotlight above.)
Click here to register.
April 5: 3 PM – 4 PM ET
Sylvia Baedorf Kassis, MPH, will present on the MRCT Center’s Clinical Research Glossary at the Network of the National Library of Medicine’s “Health Misinformation Symposium: Explore the History, Research, and Solutions.”
Click here to learn more and register.
April 13: 1 PM – 3:30 PM ET
Bioethics Collaborative (BC): Trials and Tribulations of N of 1 Trials (open to BC Sponsors and select guests)
N-of-1 trials share a common feature: trials are single-subject clinical trial designs with the goal of determining how an individual patient responds to treatment intervention(s), often involving a “pre-post” design. These trials can take a number of forms, spanning different purposes and applications, advantages, and challenges. The discussion will focus on the ethical and regulatory issues attendant with these trials.
April 18: 2:00 PM ET
Barbara Bierer will be presenting with Jamie Tyrone, patient advocate, and Sarah Walter, Alzheimer’s Clinical Trial Consortium, on “Sharing Individual Research Results in Decentralized Studies: A Participant’s Perspective, a Toolkit, and Case Study in Alzheimer’s Disease,” at #DCT2023, the Decentralized Clinical Trials conference in Boston, MA.
Click here for more information and to register.
April 28: 1:00 PM ET
MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky will present, “Equitable of People with Disabilities in Clinical Research” at the Ethics Grand Rounds at the Center for Bioethics at the University of Minnesota.
Click here for more information and to register.
May 2: 12 – 1 PM ET
Returning Individual Research Results and Data to Participants: Experience from the Field
The MRCT Center is pleased to release a set of four case study experiences: from planning and implementing tools and procedures to returning individual results and data to research participants. Join us for a moderated discussion with stakeholders as they share lessons learned and strategies for the future.
Click here to register.
May 4: 11 AM – 12 PM ET
Accessibility by Design (AbD) in Clinical Research Toolkit Webinar
Commitment to greater inclusion of people with disabilities in clinical trials requires identifying the barriers to participation, study planning, and execution.
Please join us on May 4th, 2023, 11:00 am – 12:00 pm ET as we launch the Accessibility by Design (AbD) in Clinical Research Toolkit, a product developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
Click here to register for the webinar.
Publications
March 8, 2023: The MRCT Center submitted comments to FDA on “Investigational New Drug Application Annual Reporting; A Proposed Rule.”
March 29, 2023: Dr. Barbara Bierer and Laura Meloney collaborated with Ariel Carmeli, a graduate student at Harvard Medical School Department of Biomedical Informatics and Harvard Business School, to develop a dynamic data visualization tool. The tool allows users to explore demographic representation in clinical trials associated with 339 FDA drug and biologic approvals from 2015-2021, using data from FDA Drug Trials Snapshots. The tool can help organizations improve trial representation and enhance health equity by providing information on trial representation over time, according to race, ethnicity, age, and sex, across therapeutic areas and pharmaceutical sponsors.
The tool, entitled “Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products,” was published in Cell Patterns.
MRCT Center Updates
Dr. Barbara Bierer joined the Board at Generation Patient, a non-profit organization dedicated to advocacy initiatives for young adults living with chronic and rare conditions to ensure that they have the opportunities and resources to thrive. She said, “The opportunity to engage with an organization dedicated to and led by young people living with chronic conditions, and involved in care and clinical research, was compelling. Too often, the medical enterprise talks about patients, but not with patients. We must elevate the voices and perspectives of those with the lived experience to support one another and to inform our collective future efforts.”