March 2024 Newsletter

In the Spotlight

Please join us on Tuesday, April 2, from 12 – 1 PM ET to celebrate the MRCT Center’s newly expanded Clinical Research Glossary.

This plain-language global standard has been developed in collaboration with CDISC to benefit research participants and anyone interested in developing easy-to-understand research materials.

With over 160 definitions, including images and supportive information, the MRCT Center’s Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.

Learn more about:

  • Building trust and transparency with participants through plain language information sharing.
  • The dedicated team members and robust process that is followed to create this global standard.
  • Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials. 

We look forward to sharing this important expanded resource with you.

Click here to register.

Please join us on Thursday, June 6, from 9 – 11:00 AM ET for the virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF). We will hear about a comprehensive training program in Canada based on the JTF Framework, coordinate ongoing activities, and review updates.

Please register here. 

As part of a recent update, we implemented a new Accessibility widget that allows users to access our website in over 50 languages and modify the user experience for many accessibility profiles. Explore this functionality by clicking on the Accessibility Menu icon on any page of the MRCT Center website.

We continue to add downloadable PDF translations of many of our resources, too, including the JTF Framework, now available in 10 languages here, and several pediatric informational brochures, available in Arabic and Urdu, as well as other languages.

Events & Presentations

March 7: The MRCT Center held a webinar to introduce the Research Ethics Action Collaborative for HRPPs (REACH) project, 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. Hayat Ahmed organized the webinar, and Barbara Bierer (MRCT Center), Ivy R. Tillman (PRIM&R), Michelle Feige (AAHRPP), and Martha F. Jones (MGB) presented. Webinar assets are available here, including the recording, slides, list of resources, Q&A, and a survey.

March 12: Barbara Bierer presented on the limitations of, and possible solutions to, regulatory pathways that involve non-life-threatening research in which consent is not feasible. Neither the FDA nor HHS has a readily available path to permit clinical research in settings that do not fit the specified exceptions from informed consent (EFIC) guidance (e.g., emergent settings in which consent is not possible but the condition is not life-threatening and available treatments are unproven or unsatisfactory). The conference, convened by the National Institutes of Neurological Diseases and Stroke (NINDS), NIH, explored the necessary components and guardrails that would allow this necessary research to proceed.

March 13: Barbara Bierer moderated a compelling session at DIA Europe 2024 entitled “Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review.” She was joined by colleagues Sneha Dave (Generation Patient, USA), Christina Bucci-Rechtweg (Novartis, USA), Siri Wang (Norwegian Medical Products Agency, Norway), and Dominik Karres (European Medicines Agency, The Netherlands) in a discussion that highlighted the importance—and challenges—of ensuring access of safe and effective medicines to children.  

March 22: Dr. Willyanne DeCormier Plosky conducted a training on the Inclusion of People with Disabilities in Clinical Research with Fellows from the Leadership Education in Neurodevelopmental and Related Disabilities (The LEND program) at Boston Children’s Hospital Institute for Community Inclusion. 

March 28: Sylvia Baedorf Kassis was a panelist for TransCelerate’s Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package webinar, where attendees learned about general considerations to enable data return to clinical study participants. 

March 28: Barbara Bierer was a panelist at the “Fostering Collaboration to Advance Representation Enrollment in Clinical Trials” webinar hosted by the Duke-Margolis Institute for Health Policy.

March 29: Dr. Barbara Bierer participated in a virtual roundtable co-hosted by FasterCures/Milken Institute, the Reagan Udall Foundation, the Clinical Trials Transformation Initiative, and the Foundation for NIH on “Imperatives for US Clinical Research Leadership and Coordination.” This virtual roundtable shared several initiatives underway across the government, private- and nonprofit sectors to build and coordinate clinical research infrastructure and capacity and to articulate and gain alignment around collective goals for the immediate term in 2024 while laying the groundwork for the future.

April 2, 12 – 1 PM ET: Clinical Research Glossary: New Words, New Opportunities webinar. (See Spotlight above). Click here to register.

April 4-5: Barbara Bierer will present at the Decentralized Clinical Trial’s two-day in-person workshop hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA.

  • April 4: Decentralized Clinical Trials: An Evolving Landscape Decentralized Clinical Trials: An Evolving Landscape will review the regulatory, ethical, and operational challenges in the planning and execution of such trials. The roles and responsibilities of PIs and other research and clinical team members will be discussed, as well as considerations for IRBs and institutional human research protection programs (HRPPs). 
  • April 5: Ethics Review of Decentralized Clinical Trials Dr. Bierer will review the ethical and regulatory responsibilities of sponsors, investigators, institutional review boards, and other stakeholders when planning and implementing DCTs. 

April 9: Dr. Willyanne DeCormier Plosky will participate in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit: a plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research” and a breakout session entitled “Inclusivity Forum: People with Disabilities.” 

April 11, 10 AM -2 PM (Closed Meeting). Barbara Bierer will discuss, “The Clinical Trial Ecosystem, IRB, Investigators, Health Systems and Regulatory Authority – Roles, Responsibilities, and Requirements” at the Clinical Trials & Operational Considerations and Excellence Workshop, a workshop aimed at deepening the understanding of the regulatory system for clinical trials in Costa Rica and the United States, and its global context, co-organized by the US FDA and Costa Rican Ministry of Health.

May 3, 1:30-4 PM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

March 1: In an article, “Ethical Considerations in Decentralized Clinical Trials,” published in the Journal of Bioethical Inquiry, Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.  

March 21: The MRCT Center submitted public comments to support the FDA’s draft guidance, “Master Protocols for Drug and Biological Product Development: Guidance for Industry,” and addressing several areas that could benefit from further clarification and guidance, highlighting the need for specificity in rare disease trials and informed consent practices.

We are thrilled to welcome four new Program Managers to our team:

Trevor Baker will be primarily involved in projects on Artificial Intelligence, Environmental Sustainability, and Platform Studies. 

Before joining the MRCT center, Trevor worked as a Research Project Manager at Boston Medical Center on a multi-regional trial in the research area of overdose prevention. 

Emina Berbic will be primarily involved in the Bioethics Collaborative, Cell and Gene Therapy, and Decentralized Clinical Trials projects.

Before joining the MRCT Center, Emina was a Project Manager at MGH, spearheading initiatives to innovate care for bipolar disorder. Her diverse background includes involvement in clinical trials within a global CRO and contributing as a graduate research assistant to the sidHARTe project, which concentrated on fortifying emergency health systems in emergency obstetric and neonatal care. Additionally, she contributed to a project addressing the double disease burden in Eswatini during her time at Columbia University.

Alex Marroquín joined the MRCT Center in March 2024 as a Program Manager. Alex is primarily involved in projects related to patient broad consent and Center communications.

Prior to joining the MRCT Center, Alex worked for Boston University/Boston Medical Center as a data analyst and research coordinator in sub-Saharan countries.

Emad Salman Shaikh will focus primarily on developing and designing a series of training modules. He is also collaborating on harmonizing efforts to build capacity for clinical research in new geographical regions.

Emad earned an MD from Pakistan and did his residency training in Orthopedics at the ACGME-I accredited Weil Cornell affiliated Hamad General Hospital in Doha, Qatar. He brings 15 years of experience in direct patient care, medical affairs, clinical trial operations, and management. Previously, he worked for Massachusetts General Hospital, among others. He has also contributed to designing studies, writing several articles, poster abstracts, book chapters, and quality improvement 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.