Strategies to Address Underrepresentation in Research

In epidemiologic studies, measurement biases between genders can distort our understanding of health outcomes. Measurement scales, diagnostic criteria, and even data collection methods often reflect historical biases that favor one gender over another (e.g., may not capture gender-specific symptomology). This skewed approach has deep roots. Instead of the default being inclusion, the default was exclusion when it came to women in clinical trials—a choice driven by societal, cultural, and scientific biases. Concerns about reproductive health, like potential risks to fetuses or hormonal shifts from menstruation, were cited to bar women of childbearing age, even when irrelevant to the study. Male physiology was treated as the "standard," with trials overwhelmingly designed for men under the false assumption that gender differences in drug responses or side effects were trivial. Women’s hormonal variability was framed as a problem to avoid, and the absence of women in medical leadership cemented their exclusion for decades. The fix goes beyond solidarity statements on women's day. We need more inclusive approaches in study design: 1️⃣ Stratify by gender—and age—when sampling in clinical studies: Stratifying by gender during recruitment ensures enough women are included. But in some cases, gender alone isn’t enough—older women are often underrepresented, missing issues like perimenopause or menopause. Stratifying by age (e.g., <50 vs. 50+) and gender creates four groups—older men, younger men, older women, younger women—letting us probe treatment effects or disease patterns across diverse groups. 2️⃣ Test for effect modification by gender: Analyzing whether gender alters an intervention’s impact can reveal critical biological insights. If a treatment helps everyone but benefits one gender more, that’s a key finding, for better or for worse. 3️⃣ Seek female co-authors deliberately: Especially for women’s health topics, diverse teams matter. An all-male group risks missing key variables only flagged late (say, in peer review) because no one saw the female perspective. This can introduce unmeasured confounding. Once the work’s done, don’t judge author contributions by nouns or pronouns (Jack, Jill, him, her)—that’s the wrong lens. Focus on verbs and adverbs (analyzed, wrote, thoroughly, expertly): what was done and how well. 4️⃣ Power Studies for Subgroup Analysis: Design trials with enough statistical power to detect gender-specific differences, avoiding the trap of underpowered, one-size-fits-all conclusions. Gender sensitivity isn’t just about methods—it’s also about language. 🗣️ Words shape perception, and outdated terms entrench exclusion. Small shifts matter: ❌ Chairman → ✅ Chair or Chairperson ❌ Mankind → ✅ Humanity ❌ Man-made → ✅ Synthetic or Artificial ❌ Manpower → ✅ Personnel ❌ Layman → ✅ Layperson ❌ Middleman → ✅ Intermediary It’s time our science mirrors reality—for everyone. 🌍 #Chisquares #GenderBias #InclusiveResearch

𝗦𝗵𝗼𝗰𝗸𝗶𝗻𝗴 𝗧𝗿𝘂𝘁𝗵: 𝗧𝗵𝗲𝗿𝗲'𝘀 𝗮 𝗳𝘂𝗻𝗱𝗮𝗺𝗲𝗻𝘁𝗮𝗹 𝗹𝗮𝗰𝗸 𝗼𝗳 𝘁𝗿𝘂𝘀𝘁 𝗯𝗲𝘁𝘄𝗲𝗲𝗻 𝗿𝗲𝘀𝗲𝗮𝗿𝗰𝗵𝗲𝗿𝘀 𝗮𝗻𝗱 𝗔𝗳𝗿𝗶𝗰𝗮𝗻 𝗔𝗺𝗲𝗿𝗶𝗰𝗮𝗻 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝗻𝘁𝘀 𝗶𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. Many participants fear that doctors might make persuasive statements to encourage participation but fail to uphold their promises. This fear undermines the very essence of the informed consent process. So, how can the clinical research industry build trust? 🔹𝗧𝗿𝗮𝗻𝘀𝗽𝗮𝗿𝗲𝗻𝗰𝘆: Be clear and honest about the study's purpose, risks, and benefits. Transparency helps participants make informed decisions. 🔹𝗖𝗼𝗻𝘀𝗶𝘀𝘁𝗲𝗻𝗰𝘆: Ensure that all promises and commitments made to participants are kept. Consistency in actions and communication builds credibility. 🔹𝗘𝗻𝗴𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Foster an open dialogue with participants, addressing their concerns and questions promptly. Engaging with participants on a personal level shows respect and builds trust. 🔹𝗘𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻: Provide comprehensive education about clinical research processes, emphasizing ethical standards and participant rights. Educated participants are more likely to trust the research. 🔹𝗔𝗰𝗰𝗼𝘂𝗻𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆: Implement systems to monitor and enforce ethical standards. Accountability ensures that researchers adhere to the highest ethical practices. By prioritizing these steps, the clinical research industry can enhance trust and foster stronger relationships with participants. Trust is not just a benefit—it's a necessity for advancing medical science ethically and effectively. #clinicaltrialdiversity, #clinicalresearch, #ClinicalTrials --- I help clinical research professionals drive diverse patient enrollment by building trust with underrepresented communities, while supporting mental health to foster equity in research and resilience in professionals. Let's chat!

96% of our knowledge of humans comes from 12% of the world's cultural contexts. Our understanding of humans needs to stop being so WEIRD. Western. Educated. Industrialized. Rich. Democratic. The study of human development specifically has a representation crisis: A 2023 study found that 84% of studies relied exclusively on data from geographical regions inhabited by less than 7% of the world’s population. This is more than just bad science. These biases in our research directly shape how we define “good” babies/parents: ⇢ Attachment measures standardized on Western families pathologize cultural caregiving practices around the world ⇢ Developmental assessments fail to account for cultural variation in milestones ⇢ Mental health screening tools assume nuclear families and individualistic values Here's your action item. First, ask yourself: Leaders: Do your policies account for diverse family structures and ways of learning? Maternal care providers: How are your assessment tools validated across cultures? Policymakers: Whose development is centered in your early childhood initiatives? Researchers: Who designs your research questions and methods? Now, apply 5 ways to combat these biases: 1. Re-examine your measurement tools - Validate assessments across cultures - let cultural experts lead tool development - Question Western-centric assumptions 2. Challenge your frameworks - Question "universal" theories - Consider cultural epistemologies - Recognize multiple pathways 3. Transform your training - Include cultural humility education - Center diverse family structures - Challenge deficit-based perspectives 4. Adjust your implementation - Allow flexible delivery methods - Adapt to local caregiving practices - Support indigenous knowledge systems 5. Share power - Let communities lead research design - Support community-led initiatives - Redistribute research resources Remember: Good science requires representation. Better representation creates better science. ↓ What’s an example from your work that made you question whether an approach was actually inclusive? How have you overcome cultural biases? - • • • • • • • • • • • • • • • • • • • • • • • • • • • For more on research + babies ↓ Follow Emily Little, PhD Join my newsletter: https://lnkd.in/gCJa6pM5

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

🔬 Advancing the Science of Recruitment for Alzheimer’s Clinical Trials: Check out the compelling new paper in The Journal of Prevention of Alzheimer's Disease JPAD from the USC Clinical Trial Recruitment Lab, which highlights: • Key barriers to inclusive recruitment — from socioeconomic and cultural disparities to disparities in trial design and access. • Emerging strategies, such as community partnerships, faith-based engagement, multi‑lingual outreach, and decentralized enrollment models. • Policy recommendations to shift the standard—calling for regulatory incentives, enhanced funding for underrepresented communities, and metrics to track diversity in enrollment. Why it matters: As we enter a new era of hope with #amyloid-targeting and precision-based therapies, achieving truly representative clinical trials is essential—for both scientific integrity and health equity. When diverse populations are included in trial design, we gain better insight into safety, efficacy, and real-world impact. Would love to hear from research colleagues, trial sponsors, and policy advocates: - What recruitment strategies have you found most effective? #clinicaltrials #Alzheimers Dana P Goldman Phyllis Ferrell Rema Raman PhD Paul Aisen VK Vu Desi Peneva Maria-Alice Manetas Mireille Jacobson

Enhancing Minority Representation in Medical Research: A Call to Action In the pursuit of health equity, the role of diverse participation in medical research cannot be overstated. Recent statistics underscore a stark disparity: while 40% of the U.S. population identifies as non-white, minority participation in clinical trials is significantly lower. For instance, Hispanic individuals comprise 18.5% of the population but represent only 1% of clinical trial participants. The National Hispanic Medical Association (NHMA) has continued reaching out to elevate this conversation. In AltaMed Health Services , lead by amazing leaders Gloria Itzel Montiel Adrienne Martinez-Hollingsworth, PhD, RN, PHN, WAN Nena Davis and other amazing leaders, continue to be Trail Blazers in this field. This gap in representation not only limits the generalizability of research findings but also potentially exacerbates health disparities. It’s crucial that our research reflects the diverse tapestry that is our community, ensuring that treatments and interventions are effective across all populations. Here are three proactive steps we can take to increase minority representation in medical research: 1. Education and Awareness: Initiatives aimed at educating underrepresented communities about the importance and safety of clinical research can dispel myths and build trust. Understanding that participation is both impactful and secure is the first step toward change. 2. Community Engagement: Partnerships with community leaders and healthcare providers can foster an environment where research is accessible. Simplifying the participation process and providing clear, multilingual explanations of study purposes and benefits can significantly enhance engagement. 3. Policy Advocacy: Encouraging local and national policies that incentivize diversity in research can lead to broader changes. This includes funding for studies focused on minority health issues and requirements for inclusive participant demographics in publicly funded research. Together, we can build a foundation for more inclusive research practices that benefit everyone. By amplifying the voices and addressing the health concerns of underrepresented communities, we pave the way for a healthier tomorrow. Thanks to Amairani Hernandez from CALÓ News for elevating this conversation Here is the entire article https://lnkd.in/g92BVs-J #AltaMed #DRSHAPS #Research #Representation #NMHA #AllofUs

Is it time to rethink how we use race in research? A recent report by the National Academies of Science, Engineering and Medicine NASEM Health and Medicine Division challenges us to rethink the use of race in research. Everyone interested in research and health equity needs to check out the report. https://lnkd.in/gxA3WEim One of the most important messages is the call for transparency. It’s not just in the databases used for clinical algorithms but also in one’s thought processes. For instance, does one believe there is variability of drug response based on certain social determinants and why? Be explicit about one’s hypothoses so there can be discussion. A new perspective will also help us better understand why some communities face more chronic diseases and shorter life expectancies. It’s a key to addressing health disparities more effectively. We have learned a great deal over the last couple of years about race-based clinical formulas and the problems with them. Let’s build upon these new insights. As methodologies evolve, let’s focus more on genetics, environment, and social factors that give a more accurate picture of health risks and needs. This reframing isn’t just about better science; it’s about ethical responsibility. With a focus on representative, fair data, this approach could lead to policies that genuinely serve underrepresented communities. What does this mean for us? Embracing this change allows us to take actionable steps toward a healthcare system that’s both inclusive and effective. Whether you’re in research, policy, or healthcare delivery, consider how these insights could reshape your work and drive real equity. #EquityInHealthcare #ResearchInnovation #SocialDeterminants #HealthDisparities #InclusiveScience #LinkedInCommunity

I am pleased to share a new article in Health Affairs with a call to action for a coordinated, national strategy to address the longstanding gaps in representation within US clinical trials. To explore the framework and collective vision for a more inclusive future in clinical trials, read the article here: https://lnkd.in/ePpgWVxi   Evidence shows that underrepresented populations experience disproportionately high rates of serious health conditions. Yet, these same populations remain significantly underrepresented in clinical research, a disconnect that not only limits scientific understanding but also restricts access to critical advancements in care.   The Diversity Convergence Project, launched by the Clinical Trials Transformation Initiative (CTTI), Milken Institute's FasterCures, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), and with contributions from the National Academies of Sciences Engineering and Medicine, seeks to bridge this gap by advocating for a national, cross-sector approach to diversity, equity, inclusion, and access in clinical research. This article draws on our comprehensive publication, Toward a National Action Plan for Achieving Diversity in Clinical Trials, which details actionable steps across eight key areas to create a more inclusive clinical trials enterprise. We believe that true, lasting change requires commitment from every sector—academia, industry, government, patient advocacy groups, and communities. The Diversity Convergence Project calls on all stakeholders to align on this action plan to achieve a clinical trials enterprise that truly reflects the diversity of our country and advances equitable health outcomes. Join us in supporting a system where every population has equal opportunity to contribute to and benefit from scientific progress. #DiversityConvergenceProject #HealthEquity #ClinicalTrials

Recently, I had the privilege to talk with Deloitte's Christine D. Chang about the role that Community Health Centers (CHCs) can play in improving research diversity. The interview builds from Deloitte + National Association of Community Health Centers (NACHC) joint research and report titled "Broadening research participation through community engagement: CHCs can help increase the diversity and scope of clinical studies—and ultimately, improve patient outcomes". Please read more here: https://lnkd.in/e5CA2nU3. Since 1965, CHCs have grown and now represent our nation's largest primary care system with a primary care workforce of over 310K people and nearly 1500 Community Health Centers (CHCs) providing trust and care to over 32.5 million people or 1 in 10 at over 16K sites in rural, frontier, urban, suburban, tribal, and island communities. Trust will be an essential component to advance diversity in clinical trials. As highlighted in the report above, nearly 90% of health centers are either participating in clinical research or are interested in doing so. Please read the full interview and some excerpts below: Christine: "What are some ways that health centers can help researchers recruit more diverse patient populations? And how can researchers work with health centers?" Dr. Rhee: "Health centers already collaborate with many types of organizations on research, particularly academic medical centers. However, these relationships can be strengthened. For over 60 years, health centers have established a level of trust among [under-represented] populations. Trust is important to advance research. If trust is not there, patients will probably not participate. We also understand our patients. For example, researchers may not be able to attract participants if the people designing the study are not in tune with the needs of the community and the needs of patients..." Christine: "Part of NACHC's mission is to help every health center in the country become “the employer, provider, and partner of choice.” What does it mean to be a partner of choice?" Dr. Rhee: "We are now a partner of choice for teaching, for example. It's called teaching health centers. Through legislation, 100 health centers are training the next generation of primary care clinicians... Similarly, health centers can and should also be research centers and research partners in addition to providing excellent care..." NACHC believes that CHCs and our partners like Deloitte are the best, most innovative, most resilient, and most diverse part of our health system. We stand united with CHCs and our partners like Deloitte for and with the people we have served and will serve as “the best is yet to come.” Please learn more and support the CHC movement at: https://www.nachc.org. #HealthCenters #ValueCHCs #FundCHCs #WeAreNACHC https://lnkd.in/e9XGqizc

Our latest study reveals how culturally responsive strategies boost recruitment of underrepresented groups in NIH clinical trials. 📈 By addressing mistrust, culture, and communication, we achieved a 5x increase in Hispanic enrollment and a notable improvement for non-Hispanic Black patients, though not statistically significant. 🔑 Key takeaway: Inclusive trial design = better health equity.