Description: This webinar features experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies.
The moderator, MRCT Center Program Director Sylvia Baedorf Kassis, is joined by panelists from the Dana-Farber Cancer Institute: Paula Steeves, Lead Patient Advocate, Breast Oncology, Christine McLaughlin, Patient Research Advocate, and Timothy Erick, Science Writer.
Key Topics:
The core elements of creating and disseminating Plain Language Summaries.
What results to return, who to involve in the creation process, and how to approach dissemination.
How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.
The article discusses the importance of creating educational materials to improve public understanding of clinical research data, particularly in light of misinformation during the COVID-19 pandemic. It emphasizes the need for transparency and clarity in addressing issues like data privacy and the ethical sharing of information. Modern tools such as videos and infographics can make clinical research more accessible and build trust with patients and the public.
Description: This informative webinar leverages experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.
The moderator, Sylvia Baedorf Kassis, joins the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program.
Implementing a participant-centric approach, utilizing the Clinical Research Glossary, and integrating innovative elements into the consent process.
Participate in a moderated discussion and Q&A session to delve deeper into ways to enhance the informed consent process. Share your experiences and get answers to your questions.
These training modules are in PowerPoint format. They can be taken on-demand by individuals or utilized by organizations (with permission from and credit to the MRCT Center) to conduct group training sessions on Accessibility 101 topics.
Module 1 provides introductory information about disability data, ableism (and non-discrimination), disability rights, the AbD Toolkit, emerging topics in accessibility in clinical trials, and a scientific and business case for collaborating with people with disabilities on universal design.
Module 2 provides a brief background on the participant journey, from accessing transportation to a site to getting into a site to navigating medical offices and equipment within the site. The module then brings users through an exercise where they are asked to see a series of pictures that illustrate different parts of the participant journey in different settings (e.g., fixed sites, mobile sites, virtual apps). For each picture, the module user must consider the challenges for that scenario from the perspective of people with hearing, visual, mobility, cognitive and intellectual, or other disabilities.
“Creating Alt Text” is the third module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. In this ever-virtual world, we all create materials like PowerPoints and social media posts that include images, and therefore need to know how make those images more accessible for people with low vision or blindness. Module 3 provides a background on Alt Text, instructions on how to create Alt Text so that images can be “read” by screen readers, and an exercise to test the user’s facility with Alt Text.
“Assessing Color Contrast” is the fourth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. We all need to know how to make images more accessible for people with visual disabilities. One part of that universal design is using Alt Text, described in Module 3. Another is making sure that images and text boxes have sufficient color contrast between the text color and the fill (or background) color. Module 4 provides a background on color contrast, instructions on how to assess color contrast, and an exercise to test the user’s facility with assessing color contrast and adjusting colors.
“Using Plain Language” is the fifth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. Module 5 provides a background on plain language, instructions on how to adapt complex language into plain language (including how to test the grade level for the language), and an exercise to test the user’s skills with plain language.
“Developing Accessible PowerPoints” is the sixth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. Module 6 provides a background on PowerPoints and usage in the expanding world of webinars, instructions on how to develop accessible PowerPoints and an exercise to test the user’s skills with plain language. The “how-to” section of the training starts with defining the intended purpose and audience for the PowerPoint; describes design for mental processing, readability, and sensory processing; reviews elements described in other modules (e.g., Alt Text, color contrast, plain language/inclusive language); and concludes by highlighting considerations to support accessibility while the PowerPoint is presented (e.g., closed captioning).
There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.
At the March 2024 meeting of the Bioethics Collaborative, we examined ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion sought to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research?
We invite you to attend the next virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) to learn about, present updates, and coordinate ongoing activities with the JTF Framework.
Agenda Highlights:
· Launch of a participant and patient partner competencies task force.
· Delphi results from the Data Management Task Force.
· Proposed team science competencies.
· Updates on the Portuguese translation of JTF resources.
· Results from the JTF competency survey conducted in the Philippines.
· Training community workers using the JTF framework.
Comments provided to: U.S. Food and Drug Administration
Description: The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA is using to assess the community engagement, site selection, recruitment, enrollment, and retentions plans in DAPs (both for domestic and for global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. To improve the final guidance, the comments suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.
Comments provided to: National Institutes of Health
Abstract: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.
The first podcast in our new series, “Trials Beyond Borders: Building Representative Clinical Trials Worldwide.” The podcast features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky and Tinaya Gray, a consultant with ICON plc, focusing on communications between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.
Description: On Thursday, September 19, 2024, the MRCT Center and Ropes & Gray will be co-presenting a webinar to review significant changes to the federal research misconduct regulations outlined in the highly anticipated Final Rule, issued on September 12, 2024, by the U.S. Department of Health and Human Services’ (“HHS”) Office of Research Integrity (“ORI”). Ropes & Gray has prepared a redline of the changes against the current regulations (available here) and a redline of the changes against the proposed rule (available here).
The Final Rule outlines changes to the federal research misconduct regulations set forth at 42 C.F.R. Part 93 (“Part 93”). Part 93 sets forth the federal regulatory framework that must be followed for investigating allegations of research misconduct (falsification, fabrication, or plagiarism) pertaining to research in which U.S. Public Health Service funds—including NIH funds—have been provided. The changes outlined under the Final Rule are extensive and highly impactful and include significant changes from the proposed rule that was published by ORI in October 2023. By way of example, the Final Rule omits a provision in the proposed rule that would have prohibited institutions from reaching an “honest error” finding at an early stage of a research misconduct proceeding. These changes will require institutions to implement significant changes to their existing policies and practices for reviewing allegations of misconduct. The Final Rule provides that institutions must implement these changes by January 1, 2026.
For a detailed discussion of the key changes in the Final Rule, we invite you to attend our webinar on Thursday, September 19, 2024. MRCT Center Faculty Director Barbara Bierer and Ropes & Gray presenters, including Mark Barnes, co-founder and Faculty co-Director of the MRCT Center, will be joined by The University of Texas MD Anderson Cancer Center’s Madhu Purewal, Senior Legal Officer & Executive Director, Research Compliance, who will offer perspective during the question and answer portion of the webinar on the significance of the rule changes from the perspective of a large academic research institution.
