January 2024 Newsletter

In the Spotlight

We are delighted to announce the launch of the updated webpage dedicated to our Promoting Global Clinical Research in Children project. With our workgroup activities now complete, we are focused on presenting our findings and actively engaging in international projects. We offer a comprehensive suite of resources tailored for stakeholders who are directly involved or have an interest in pediatric clinical research. This includes our Including Young People in Research toolkit, our Guiding Principles, and a curated selection of pediatric-focused webinars, complete with recordings and summaries. Please visit our website for tools, publications, and materials supporting pediatric clinical research worldwide.

MRCT Center in Ethiopia

Left to Right: Marisol Guraiib, Consultant, WHO Headquarters; Hayat Ahmed, Program Manager, MRCT Center; Chinwe Iwu-Jaja, PhD, Pharmacist, WHO, Regional Office for Africa; Alambo Mssusa, Technical Officer, WHO, Regional Office for Africa; Barbara Bierer, MD, Faculty Director, MRCT Center; Heran Gerba, Director General, Ethiopian Food & Drug Authority (EFDA); Asnakech Alemu, Director of Product Safety, EFDA; Assefa Ejamo, Team Lead, EFDA; Kwasi A. Nyarko, PhD, Coordinator, AVAREF Secretariat, WHO, Regional Office for Africa
Supporting the African Vaccine Regulatory Forum (AVAREF) since 2019, Dr. Barbara Bierer and Hayat Ahmed (MRCT Center), together with Dr. Kwasi Nyarko, Alambo Mssusa, and Dr. Chinwe Iwu-Jaja (AVAREF and WHO AFRO), and Marisol Guraiib (WHO HQ Ethics Review) met in Addis Ababa, Ethiopia, on a mission recently.
AVAREF, a network of African national regulatory authorities and ethics committees, is dedicated to enhancing regulatory capacities and standardizing best practices for clinical trials across Africa. AVAREF has undertaken a “Clinical Trial Optimization” initiative to increase efficiencies, cooperation, partnerships, and quality of regulatory and ethical reviews of clinical trial processes. Several countries have been visited, and Dr. Bierer has joined two (Kenya, and Nigeria) of the previous evaluations.
The Ethiopia mission comprised a four-day assessment featuring an analysis of process, timing, and communication across the national regulatory agency, the National Research Ethics Review Board, ECs/IRBs, and Principal Investigators, culminating in final meetings encompassing discussions and recommendations to all stakeholders involved.

REACH Webinar: March 7, 12 – 1 PM ET

Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in clinical research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

We invite you to join an engaging webinar scheduled for Thursday, March 7 from 12 – 1:00 PM ET. This interactive session will explain the motivation behind this effort and explore actionable strategies to operationalize inclusion efforts in HRPPs.

The key discussion points include:

·     Making the Case for Leadership: Understand the significance of integrating inclusion and accessibility within HRPPs and explore effective ways to articulate a compelling case that resonates with stakeholders and leadership.

·     Establishing a Roadmap for Change: Delve into the process of creating a roadmap for change, navigating institutional processes, and garnering leadership buy-in to ensure a sustainable and impactful implementation of inclusion in HRPPs.

·     Presenting Resources: Explore resources available to IRBs, HRPPs, and institutions currently freely available, and provide a means for attendees to identify additional tools needed for this work.

·     Soliciting Examples: Hear from participants about successful practices and strategies implemented within their respective institutions, fostering a dynamic exchange of insights and best practices.

Join us in this collective endeavor to actively strategize and operationalize efforts within IRBs and HRPPs. Mark your calendars for March 7th, and please register here.

The MRCT Center hosted a biannual global Joint Task Force for Clinical Trial Competency (JTF) meeting on November 14, 2023. The meeting included updates from various members of the JTF and progress reports from workgroups, including Data Management, Workforce Development, Emergency Preparedness, and an open discussion.

Click here to read the meeting proceedings and view the conference slides.

Events & Presentations

January 17: Dr. Barbara Bierer presented “Ethical Review of Decentralized Clinical Trials” at a Medable webinar related to the IRB/EC Considerations for DCT Review.

January 25: Dr. Willyanne DeCormier Plosky presented in person on “Dismantling Ableism in Clinical Research: From the Basics to Breaking News” at the University of Alabama’s 2024 Symposium on Addressing Ableism in Research, Healthcare, and Higher Education.

March 7, 12 – 1 PM ET: Representatives from the MRCT Center, Mass General Brigham, AAHRPP, and PRIM&R will discuss the Research Ethics Action Collaborative for HRPPs (REACH) initiative at a webinar. (See Spotlight above.) Click here to register.

March 8, 11 AM – 2 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Advancing Inclusion: Integrating Pregnant and Lactating People in Research. Open to sponsors of the Bioethics Collaborative.

March 22, 9 – 11:30 AM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Expanded Access (Compassionate Use) for Drugs and Devices. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).


January 4: The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office of Research Integrity on Public Health Service Policies on Research Misconduct to urge for a fairer and more efficient process in research misconduct proceedings.
January 18: Barbara Bierer co-authored an article, “Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency” in Frontiers in Pharmacology.

New Sponsorship

The MRCT Center welcomes Bristol Myers Squibb as a new Executive Committee sponsor. Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines.

MRCT Center Updates

In January, Lindsey Henriques joined the MRCT Center as a Student Researcher in creative design. She is working to develop imagery for the Clinical Research Glossary, which will release an updated and enhanced website in late March. She will also work on several other MRCT Center projects.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.