Comments provided to: U.S. Food and Drug Administration
Description: The FDA draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice,” (FDA-2024-D-2052) highlights the need for maintaining scientific rigor and data reliability when using real world data (RWD) amidst diverse healthcare settings. The MRCT Center comments addressed data quality when using clinical (and variable) data, ethical and practical challenges of randomization in clinical settings, vulnerabilities in data privacy and security, and participant safety while promoting innovative approaches and pilot programs to refine implementation strategies for this purpose.
Description: The DOJ Notice of Proposed Rulemaking (NPRM), “Provisions Pertaining to Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons,” (DOJ-NSD-2024-0004) aims to safeguard sensitive U.S. personal- and government-related data from countries of concern or covered persons, emphasizing national security and data protection. MRCT Center comments highlighted the need to balance these security measures with global health priorities, recommending explicit public health and research exemptions, alignment with international standards, refined definitions, and transparent compliance to support access to health-related data and the advancement of science, medicine, and individual and public health.
Episode 2 of the Trials Beyond Borders podcast is now available on all streaming platforms. In this episode, Racquel Bruton, Associate Director and Clinical Trials Diversity Portfolio Lead at Biogen, and Willyanne DeCormier Plosky, Program Director at the MRCT Center, discuss how sponsor companies are enhancing representation in clinical trials, particularly outside the US. Racquel highlights Biogen’s longstanding commitment to reaching underrepresented populations and explores how the MRCT Center’s roadmap can help organizations develop effective diversity action plans. Tune in to learn practical insights on operationalizing diversity strategies.
Published on: November 18, 2024 and updated on May 30, 2025
The “Exit Survey Inclusive of the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit and the third of three tools in the section of the Toolkit directed more toward participants. It is important for participants in clinical research activities to give feedback about their experiences. This feedback helps research teams and organizations better understand the participant’s experience of the research activity and learn where they can improve on efforts to empower research participants and the participants’ supporting families, friends, and communities. One way to gather feedback is through a survey, which may be given to participants periodically (e.g., once a month), and/or (as an exit survey) at the end of research activities. In this tool, we aim to show examples of the topics that participants may be asked about in a survey or interview or, if not asked, that the participant may wish to share with the research team in a patient portal, email, or other format.
Please note that the Exit Survey Inclusive of the LGBTQIA+ Participant Perspective has been comprehensively updated in the 2.0 version, particularly in questions 21c-f and in the footnotes for those questions and response options. We have also included a new appendix to this tool, which provides a summary of Key Resources and Recommendations for SOGI Data Collection. These resources and recommendations are drawn from documented best practice and are meant to support researchers designing surveys and research participants that are considering how they might give feedback on their participation experience.
Published on: November 18, 2024 and updated on May 30, 2025
The “Participant Questionnaire from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the second of three tools in the section of the Toolkit directed more toward participants. There are numerous questions that participants may want to ask as they move from thinking about possible trials and sites to starting the process of enrolling and participating in a trial. Some of these questions may be covered by informational materials given to participants during the informed consent process and study visits, and some may not be. This list is to help participants prepare so that they can get the answers that they need and feel comfortable before continuing with the trial. The Participant Questionnaire tool is divided into sections that include questions to ask the research team, questions you may want to ask family, friends, and others you trust, and questions to ask yourself. It includes questions that anyone might want to ask and adds questions that LGBTQIA+ people (and/or their accompanying friends and family) might also want to ask.
Published on: November 18, 2024 and updated on May 30, 2025
The “Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the first of three tools in the section of the Toolkit directed more toward participants. This tool is meant to empower potential LGBTQIA+ participants to assess whether a site may be trustworthy and welcoming. This tool is structured in tiers, with checkpoints in between. The first tier is potential capacity, where we provide prompts, or “determination factors” based on what IS happening at a site (or in the area nearby) that LGBTQIA+ people can use in considering whether the site is potentially a good place to participate in a study. In the second tier we focus on “historical capacity,” or the things that the site HAS/HAD done to support the well-being of LGBTQIA+ people that may inspire confidence that the site is trustworthy.
The Principles of Post-Trial Responsibilities: Continued Access to an Investigational Product are 12 principles that guide the shared responsibilities and actions to provide continued access to an investigational product at the conclusion of a patient’s participation in a clinical trial. The principles, accompanied by an analysis, should be read as a whole.
The principles are designed to be used in coordination with the Framework of Responsibilities (Medicines) and (Devices), a framework of milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational product.
Developed by: MRCT Center, in collaboration with ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design.
The MRCT Center is currently developing a series of in-depth training modules to complement the video.
