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Diversity, Inclusion, and Equity in Clinical Research
Focus Area: Current Project
Focus Area: Ethics, Conduct, and Oversight
Items listed by newest to oldest in each category.
Case Studies:
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: PCSK9 (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Omapatrilat (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Clopidogrel (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Bucindolol (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Multiple Sclerosis Research Mythbusting Series (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Embedding Diversity & Inclusion within a Pharmaceutical Company (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Diverse Recruitment at Yale Center for Clinical Investigation (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Diverse Patient Engagement at a Pharmaceutical Company (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Data-driven Diversity Assessments at a Medical Device Company (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: All of Us Research Program (CASE STUDY)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH CASE STUDY: Achieving and Exceeding Clinical Trial Participant Diversity Targets (CASE STUDY)
Project-specific Websites:
Frameworks:
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: ACTION FOR CHANGE (FRAMEWORK)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: DEFINING DIVERSITY (FRAMEWORK)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: DIVERSITY PRINCIPLES AND SUPPOSITIONS (FRAMEWORK)
- MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit
Proceedings, Publications, & Public Comments:
- Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification (Publication)
- Supported decision-making can advance clinical research participation for people with disabilities (Publication)
- LAUNCH OF EQUITY BY DESIGN (EBD) IN CLINICAL RESEARCH: THE EBD METRICS FRAMEWORK (Webinar)
- SUPPORTING IRB EFFORTS TO ADVANCE DIVERSITY AND INCLUSION IN CLINICAL RESEARCH TOOLS AND RESOURCES (WEBINAR)
- Integrating Supported Decision-Making into the Clinical Research Process (Publication)
- Promoting Equity by Design in Cancer Trials (Commentary)
- STRATEGIES TO OPTIMIZE INCLUSION OF WOMEN IN MULTI-NATIONAL CLINICAL TRIALS (PUBLICATION)
- IRBS AND THE PROTECTION-INCLUSION DILEMMA: FINDING A BALANCE (PUBLICATION)
- LAUNCH OF “EQUITY BY DESIGN (EBD) IN CLINICAL RESEARCH: THE EBD METRICS FRAMEWORK” (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – July 14, 2021: Simplifying the Complexity of Translation in Clinical Research (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – May 12, 2021: Inducement or Fair Compensation? Impact on Diverse Participation (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – April 14, 2021: How to Begin (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – February 10, 2021: Role of Data in Diversity: Genetics & RWD (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – January 27, 2021: Stakeholder Roles and Responsibilities (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – January 13, 2021: Data Standards and Analysis (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – December 9, 2020: Study Conduct (Recruitment, Retention) (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – November 18, 2020: Study Design, Eligibility, Site Selection, & Feasibility (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – October 28, 2020: Workforce Development (WEBINAR)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials – October 14, 2020: Community Awareness, Access, Knowledge (WEBINAR)
- Diversity Plans to Improve Enrollment of Participants from Underrepresented Populations (Public Comments)
- Dr. Barbara Bierer is featured in the Exploring Drug Discovery and Development article “Scientists and communicators team up to increase clinical trial participation”
- Advancing the inclusion of underrepresented women in clinical research (Commentary)
- Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate (Publication)
- In Journal of Clinical and Translational Science: “Fair payment and just benefits to enhance diversity in clinical research” by MRCT Center colleagues (Publication)
- Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov (Publication)
- Committing to diversity, equity and inclusion: A call to action for clinical trials
- Biopharmas must address the reality of racial disparities in health outcomes exposed by COVID-19 (Publication)
- Response to FDA’s request for comments on strategic priorities for the Office of Minority Health and Health Equity (OMHHE) (Public Comments)
- Committing to the Inclusion of Diverse Populations in Clinical Research (Publication)
- Enhancing the Diversity of Clinical Trial Populations – Comments to FDA (Public Comments)
- Comments on US Department of Health & Human Services Healthy People 2030 Objectives (Public Comments)
Presentations:
- MRCT Center Driving Inclusion in Clinical Research webinar: Simplifying the Complexity of Translation in Clinical Research
- MRCT Center Driving Inclusion in Clinical Research webinar: Improving Inclusion of Persons with Disabilities in Clinical Research
- MRCT Center Driving Inclusion in Clinical Research webinar: Inducement or Fair Compensation? Impact on Diverse Participation
- MRCT Center Driving Inclusion in Clinical Research webinar: How to Begin
- Rare Inspiration. Changing Lives: Sarah White is part of an Alexion panel honoring Rare Disease Day
- MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data
- MRCT Center Leaning In webinar: Stakeholder Roles and Responsibilities
- MRCT Center Leaning In webinar: Data Standards & Analysis
- MRCT Center Leaning In webinar: Study Conduct (Recruitment, Retention)
- Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations. A virtual conference.
- PRIM&R WEBINAR: “THE IRB’S ROLE IN ACHIEVING DIVERSITY IN RESEARCH”
- MRCT Center Leaning In webinar: Study Design, Eligibility, Site Selection & Feasibility
- Achieving Diversity, Inclusion, Equity In Clinical Research: McKinsey Regulatory Affairs Leaders’ Roundtable (Presentation)
- The Roles and Responsibilities of the IRB in Addressing Diversity in Clinical Research (Presentation)
- MRCT Center Leaning In webinar: Workforce Development
- Ropes & Gray webinar: “Achieving Diversity, Inclusion, & Equity in Clinical Research”
- MRCT Center Leaning In webinar: Community Awareness, Access, Knowledge
- Emerging work on Diversity & Clinical Trials: A Spotlight on the MRCT (Presentation)
- The Way Forward: From ‘diagnosis’ to ‘treatment’ of COVID-19 (Presentation)
- Achieving Diversity, Inclusion, and Equity In Clinical Research (Presentation)
- Diverse Representation in Clinical Trials-Why Does It Matter and How Do We Move Forward? (Presentation)
- Diverse representation and inclusion in clinical research: Justification, opportunities, and solutions (Presentation)
- Evolving science in clinical trials in special populations (Presentation)
- Efficiencies in Clinical Research: A USA perspective (Presentation)
- An investigator perspective Data sharing in trials: Should all trials share all their data? (Presentation)
- A USA perspective on diversity and inclusion (Presentation)
- Does Diversity Matter in the Conduct of a Clinical Trial? (Presentation)
Other Resources:
Tools:
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: IRB Membership Self-Assessment Template (Self-Evaluation Survey) (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: IRB Statement of Commitment to Inclusion (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: HRPP and IRB Statement of Commitment to Inclusion (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Approaches to Support IRB members (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: IRB Health Literacy Training (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Institutional Review Board Oversight Points to Consider for IRB Reviewers to assess DEI factors at Initial and Continuing Review (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: A Resource for HRPPs: Planning a Strategy to Address Diversity, Equity, and Inclusion (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Procedural & Logistical Checklist (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: An IRB Resource for Participants: Costs and Payments (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: An IRB Resource for Investigators and Research Teams– Practical Points to Consider: Payment to Research Participants (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: An IRB Resource for Investigators and Research Teams: Including the Community Voice in Clinical Research (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Incorporating DEI into Clinical Research Protocol Templates (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Diversity & Inclusion Overlay: TransCelerate’s Common Protocol Template (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Diversity & Inclusion Overlay: NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Integrating Considerations for Diversity, Equity, and Inclusion (DEI) into a Recruitment Strategy Document (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: IRB Resources (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: Resources for IRBs/HRPPs to provide to Investigators/Research Teams (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Stakeholder Commitments and the Future (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Study Design, Conduct and Implementation (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Data Variables and Collection (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Workforce and Diversity: Training and Development (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Participant Awareness, Knowledge, and Access (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Participant and Community Engagement (TOOLS)
- DIVERSITY, INCLUSION, AND EQUITY IN CLINICAL RESEARCH: GUIDANCE TOOLKIT & USER GUIDE: Introduction (TOOLS)
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