In the Spotlight
Returning Individual Research Results and Data: Digging Deeper Webinar Series
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.
The recording, slides, and related materials from the first webinar, Pfizer’s Participant Data Return Solution, held on July 27, will be posted to our website in August.
Please join us for the two remaining sessions by registering below.
Session 2: IRB and HRPP Responsibilities
Thursday, August 17, 12 – 1:00 PM ET: Linda Coleman and Madelon Baranoski of Yale University will discuss a case about returning non-validated test results.
Thursday, September 21, 12 – 1:00 PM ET: Megan Frone of the National Cancer Institute will discuss a case about returning secondary findings.
Developing a model Diversity Action Plan (DAP) for Trial Sponsors
The Food and Drug Omnibus Reform Act of 2022 (FDORA) implemented new requirements for clinical trial diversity. Sponsors of late-stage drug and device trials must submit “diversity action plans” (DAPs) outlining their diversity goals for enrollment in the clinical study, the rationale behind those goals, and their strategies to achieve them. Therefore, the MRCT Center is developing a model DAP based on the MRCT Center’s Recruitment Strategy Document Template.
We have already identified important themes and considerations that will enhance the effectiveness and impact of these DAPs. To strengthen the completeness and applicability of this initiative, the MRCT Center is actively gathering DAPs from trial sponsors. If you have one or more examples of a DAP template that you would be willing to share, please email hahmed@bwh.harvard.edu. We will anonymize and use only to build the best DAP template we can.
Promoting Global Clinical Research in Children at the iCAN Summit
MRCT Center Program and Team Director Lisa Koppelman participated in an iCAN multi-disciplinary panel on pediatric clinical trials. The annual iCAN Summit is organized by the International Children’s Advisory Network (iCAN), a consortium of Young Persons Advisory Groups (YPAGS) that advocate for children and families in medicine, research, and innovation.
The MRCT Center and iCAN have collaborated closely to inform and center children’s voices in clinical research. iCAN youth participated in the review of the MRCT Center’s informational materials tailored to a pediatric audience interested or involved in clinical research. iCAN produced three videos showcasing the youth perspective on various research and clinical care aspects. These videos premiered in three of the MRCT Center’s five-part webinar series, Advancing International Pediatric Research.
In a delightful full-circle moment at the iCAN Summit, Lisa shared a warm, in-person exchange with Meg, the spotlight feature of a short video sharing the importance of keeping children well informed throughout the trial journey.
Click here to learn more about the MRCT Center’s pediatric work and the Including Young People in Clinical Research Toolkit.
Events & Presentations
July 27: MRCT Center Program Director Sylvia Baedorf Kassis led a moderated conversation in the first session of a 3-part webinar summer series, Returning Individual Results and Data: Digging Deeper – Pfizer’s Participant Data Return Solution. In August, webinar resources, including the recording, slides, and related materials, will be posted to the MRCT Center website.
August 17: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper
Session 2: IRB and HRPP Responsibilities (see Spotlight above)
September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Data Privacy and Foreign Influence. Open to R3 Sponsors.
September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper
Session 3: Genetic Testing (see Spotlight above)
Publications
June 19: MRCT Center Faculty Director Dr. Barbara Bierer and Program Director Sylvia Baedorf Kassis published an article, “Communicating complex numerical information in clinical research,” in Frontiers in Communication, stressing the importance of numeracy as a component of health literacy.
June 30: The MRCT Center submitted public comments to the Institute for Clinical and Economic Review (ICER) regarding proposed changes to the 2023 Value Assessment Framework. Click here to view.
July 5: MRCT Center co-Faculty Directors Dr. Barbara Bierer and Mark Barnes submitted public comments on the NIH Updated Policy Guidance for Subaward/Consortium Agreements, recommending that the guidance be updated to provide greater flexibility to institutions as to the types of documentation that foreign sub-recipients may be expected to share with prime awardees. Click here to view.
July 30: The MRCT Center submitted public comments on the proposed revision of the EU general pharmaceuticals legislation. In broad support of merging the Paediatrics Regulation with general pharmaceuticals legislation, our comments urged the European Commission to ensure pediatric medicines development remains an implementation priority to meet the needs of children throughout Europe. To read the full public comment, click here.
July 2023: The MRCT Center’s work in collaboration with Medable, Inc., on IRB/EC Considerations for DCT Review continues to garner attention in several publications:
· ACRP
· CenterWatch
· PM360
· PharmaVoice
MRCT Center Updates
The MRCT Center welcomes Erin Chaves, Administrative Coordinator. She contributes to the Center’s successful operations, including financial and administrative tasks, management of events, coordinating calendars, and other administrative duties.
Summer Reading
Developing imagery for the Clinical Research Glossary
This summer, after reviewing over 200 applications, the MRCT Center welcomed student interns Yimeng (Anna) Lyu and Xinyu (Sandra) Ye to work with MRCT Center colleagues to develop graphic design products for Health Literacy, Individual Return of Results, Diversity, Pediatrics, and other Center projects. They have focused on a comprehensive Clinical Research Glossary graphics library to accompany the plain-language definitions. All images will eventually be available for free use under the terms of our Creative Commons license.
“We hear repeatedly from patients and industry professionals how important images are to effective communication and understanding,” said Program Director Sylvia Baedorf Kassis. “We are thrilled to be able to meet this need while providing an educational opportunity for the next generation of science communicators. This effort crystallizes the MRCT Center’s commitment to promoting a holistic approach to clinical research understanding.”
For Sandra, a junior at Vanderbilt University majoring in Cognitive Studies and Communication of Science and Technology, the work has been an opportunity to meld two interests: science communication and graphic design. “It has been an incredible experience being part of the Health Literacy project team and seeing how a glossary can significantly improve health communication. I focus on visualizing common yet complex research concepts for potential clinical trial participants. I am grateful that my passion and ideas are appreciated here. Receiving feedback from my multi-talented colleagues is enlightening, and I look forward to seeing our combined efforts come to fruition.”
MRCT Center Project Manager Kayleigh To has been working closely with the interns. “Just as the plain language definitions go through a rigorous and iterative review process, these images undergo a similar creative development,” she said. “Ideas for the images are brainstormed before multiple drafts are created, each building upon and incorporating feedback and input. Such care and consideration are a hallmark of the work to create the glossary.”
Anna, a Fine Arts major with a concentration in Graphic Design at Tufts University, sees the work as an enriching and challenging opportunity to innovate in the intersection of art and science. “As part of a multidisciplinary team, I bring my expertise in art and design to create brand-aligned visual assets, including illustrations, icons, and a style guide. With user-centered and inclusive design, I aim to craft visuals that simplify complex concepts for diverse audiences. I am proud that our work will enhance health literacy and empower individuals to make informed decisions about their participation in clinical research.”
The MRCT Center’s Clinical Research Glossary currently has 53 plain-language terms. A bank of 118 additional words has recently undergone an extensive public review with CDISC and is slated to be added to the glossary by the end of the year.
Click here to read more about our process of developing a consensus-driven, plain-language clinical research glossary.
Click here to learn more about the MRCT Center’s collaboration with CDISC to make our plain-language clinical research glossary a global standard.
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.