Diversity-Focused Assessment Methods

FDA's Draft Guidance on Diversity Action Plans: 5 Key Areas Where Patient Preference Studies Could Enhance Clinical Trial Diversity The FDA recently released a draft guidance on Diversity Action Plans for clinical trials. As someone deeply involved in patient-centered research, I've reviewed the document and want to share some insights that could be valuable for sponsors, researchers, and patient advocates. The guidance emphasizes opportunities for patient input, but there's an opportunity to strengthen it by incorporating quantitative patient preference studies. Here are 5 key areas where such studies could make a significant impact: 1. Reducing Participant Burden: The guidance recommends "reducing participant burden" (p.14, lines 411-415). Structured weighting methods could quantitatively assess which burdens are most significant to patients, helping prioritize reduction efforts. 2. Enrollment and Retention Strategies: While the FDA "encourages sponsors to consult patients" (p.13, lines 396-398), stated preference methods like conjoint analysis could evaluate patient preferences for different strategies, enhancing effectiveness. 3. Consumer-Friendly Communication: The guidance suggests using "consumer-friendly language" (p.21, lines 706-707). Health state utility methods could quantify how well patients understand different communication approaches, ensuring clarity. 4. Community Engagement: For "implementing sustained community engagement" (p.13, lines 400-403), revealed preference methods could assess the effectiveness of different strategies in real-world settings. 5. Improving Study Awareness: To enhance "study participant awareness and knowledge" (p.14, lines 409-410), best-worst scaling exercises could rank the effectiveness of different strategies from the patient perspective. By integrating these quantitative preference assessment methods, sponsors can create more effective, patient-centered Diversity Action Plans. This could lead to improved enrollment of underrepresented populations and more generalizable clinical trial results. What are your thoughts on the draft guidance? How do you see patient preference studies fitting into the future of clinical trial diversity? #ClinicalTrialDesign #PatientPreferences #FDA #RegulatoryScience #PatientVoice

Participatory assessments are a transformative approach to understanding the nuanced needs, priorities, and vulnerabilities of communities. This Guidance on Participatory Assessments, developed by experts at Catholic Relief Services, presents a robust framework for integrating participatory methods into the project design and assessment process. By centering the voices of the most marginalized and vulnerable households, this guide ensures that project designs are both relevant and responsive to the diverse realities of the people they serve. The document outlines a step-by-step process, from meticulous assessment planning and the application of participatory tools—such as transect walks, mapping, and focus group discussions—to the thorough analysis of findings using structured methodologies like problem trees and comparative matrices. It emphasizes flexibility, inclusivity, and ethical considerations, equipping practitioners to navigate complex community dynamics and foster meaningful engagement. Tailored for humanitarian professionals and development practitioners, this resource empowers its audience to conduct assessments that go beyond data collection, creating opportunities for collaboration, empowerment, and sustained community-led change. By adopting these approaches, practitioners can craft interventions that are not only impactful but also grounded in the lived experiences and aspirations of the communities they aim to uplift.

"𝗦𝗵𝗲 𝗱𝗼𝗲𝘀𝗻'𝘁 𝘀𝗽𝗲𝗮𝗸 𝗺𝘂𝗰𝗵... 𝗮𝗿𝗲 𝘆𝗼𝘂 𝘀𝘂𝗿𝗲 𝘀𝗵𝗲 𝗶𝘀 𝗿𝗲𝗮𝗱𝘆?" 𝘈 𝘱𝘰𝘴𝘵 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵 𝘥𝘪𝘴𝘤𝘶𝘴𝘴𝘪𝘰𝘯 - 𝘈 𝘣𝘪𝘢𝘴 - 𝘈 𝘱𝘳𝘰𝘤𝘦𝘴𝘴 𝘧𝘢𝘪𝘭𝘶𝘳𝘦 Have you noticed how our talent assessments often favour the loudest voice in the room? A few weeks back, during a simulated assessment activity, I witnessed something fascinating. The quietest participant had the most innovative solutions, yet barely got noticed in group discussions. A senior stakeholder cum internal assessor was not sure if she was ready! 𝗧𝗵𝗲 𝗜𝗿𝗼𝗻𝘆: We claim to value diverse thinking, yet our assessment methods often reward theatrical presence over thoughtful impact. A few major biases and traps that I have witnessed: 🔴  𝗧𝗵𝗲 𝗣𝗿𝗲𝘀𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗧𝗿𝗮𝗽 When every assessment includes a presentation, we unconsciously favour those who perform well under spotlights, not necessarily those who excel in daily leadership moments. 🔴  𝗧𝗵𝗲 𝗙𝗶𝗿𝘀𝘁 𝗜𝗺𝗽𝗿𝗲𝘀𝘀𝗶𝗼𝗻 𝗕𝗶𝗮𝘀 Quick, charismatic responses often overshadow deeper, more considered thinking. But remember - in real leadership, thoughtful decisions beat quick answers. 🔴  𝗧𝗵𝗲 𝗘𝘅𝘁𝗿𝗼𝘃𝗲𝗿𝘁 𝗜𝗱𝗲𝗮𝗹 We've created an unspoken template of what leadership "looks like" - usually extroverted, always vocal, perpetually visible. This needs to change! 🔴  𝗧𝗵𝗲 𝗦𝗽𝗲𝗲𝗱 𝗠𝘆𝘁𝗵 Quick responses get rated higher than measured ones, even when the latter show deeper strategic thinking. 🔴  𝗧𝗵𝗲 𝗖𝘂𝗹𝘁𝘂𝗿𝗮𝗹 𝗕𝗹𝗶𝗻𝗱𝘀𝗽𝗼𝘁 Different cultures express leadership differently. Are we missing out on global talent because we're stuck in one cultural frame? 𝗪𝗵𝗮𝘁 𝗰𝗮𝗻 𝗼𝗿𝗴𝗮𝗻𝗶𝘀𝗮𝘁𝗶𝗼𝗻𝘀 𝗱𝗼 𝗱𝗶𝗳𝗳𝗲𝗿𝗲𝗻𝘁𝗹𝘆 𝘁𝗼 𝗮𝗱𝗱𝗿𝗲𝘀𝘀 𝘁𝗵𝗲𝘀𝗲 𝘁𝗿𝗮𝗽𝘀? 1. Diversify assessment methods 2. Look for impact over impression 3. Create space for different thinking styles 4. Measure actual results, not just presentation 5. Train assessors on unconscious bias (𝗺𝘆 𝗳𝗮𝘃𝗼𝘂𝗿𝗶𝘁𝗲) 𝐇𝐚𝐯𝐞 𝐲𝐨𝐮 𝐰𝐢𝐭𝐧𝐞𝐬𝐬𝐞𝐝 𝐭𝐡𝐢𝐬? 𝐑𝐞𝐚𝐥 𝐭𝐚𝐥𝐞𝐧𝐭 𝐧𝐨𝐭 𝐛𝐞𝐢𝐧𝐠 𝐠𝐢𝐯𝐞𝐧 𝐚 𝐜𝐡𝐚𝐧𝐜𝐞 𝐛𝐞𝐜𝐚𝐮𝐬𝐞 𝐭𝐡𝐞𝐲 𝐝𝐢𝐝 𝐧𝐨𝐭 𝐡𝐚𝐯𝐞 𝐭𝐡𝐚𝐭 '𝐄𝐱𝐞𝐜𝐮𝐭𝐢𝐯𝐞 𝐩𝐫𝐞𝐬𝐞𝐧𝐜𝐞'... 𝐈'𝐥𝐥 𝐛𝐞 𝐜𝐮𝐫𝐢𝐨𝐮𝐬 𝐭𝐨 𝐡𝐞𝐚𝐫 𝐲𝐨𝐮𝐫 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 #honestconsulting #learninganddevelopment #leadership #transventionsglobal 📈 𝘈𝘵 𝘛𝘳𝘢𝘯𝘴𝘷𝘦𝘯𝘵𝘪𝘰𝘯𝘴 𝘎𝘭𝘰𝘣𝘢𝘭, 𝘸𝘦 𝘥𝘦𝘴𝘪𝘨𝘯 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵𝘴 𝘵𝘩𝘢𝘵 𝘶𝘯𝘤𝘰𝘷𝘦𝘳 𝘳𝘦𝘢𝘭 𝘭𝘦𝘢𝘥𝘦𝘳𝘴𝘩𝘪𝘱 𝘱𝘰𝘵𝘦𝘯𝘵𝘪𝘢𝘭, 𝘯𝘰𝘵 𝘫𝘶𝘴𝘵 𝘴𝘶𝘳𝘧𝘢𝘤𝘦-𝘭𝘦𝘷𝘦𝘭 𝘤𝘩𝘢𝘳𝘪𝘴𝘮𝘢. 𝘓𝘦𝘵'𝘴 𝘵𝘢𝘭𝘬 𝘪𝘧 𝘺𝘰𝘶'𝘳𝘦 𝘳𝘦𝘢𝘥𝘺 𝘵𝘰 𝘳𝘦𝘵𝘩𝘪𝘯𝘬 𝘺𝘰𝘶𝘳 𝘵𝘢𝘭𝘦𝘯𝘵 𝘢𝘴𝘴𝘦𝘴𝘴𝘮𝘦𝘯𝘵 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩.

Evaluations need to go beyond gender to be fully inclusive. Disability should also be addressed in evaluations. Check out this guide with practical steps to do so. Though developed for UNICEF, the principles can be applied more widely. Develop Inclusive Terms of Reference (ToR) ↳ Specify disability considerations in your evaluation’s objectives, methodology, and stakeholder engagement. Engage Diverse Stakeholders Early ↳ Involve people with disabilities during the planning phase to ensure diverse perspectives shape the evaluation. Use Accessible Data Collection Methods ↳ Ensure surveys, interviews, and focus groups are designed to be accessible, with options like sign language interpreters, large print, or digital surveys. Check Assumptions Continuously ↳ Regularly revisit assumptions about how disability impacts to ensure the evaluation remains inclusive as it progresses. #DisabilityInclusion #Disability