DiversiTrials

🚨 MUST READ: The FDA Diversity Action Plan (DAP) is BACK! 🚨 🌍 Hello, Bonjour, Hola, Marhaba! For those who may have missed the memo, the FDA Diversity Action Plan (DAP) is officially back online. 📢 Given the agency’s recent workforce challenges, I propose that Hadi Danawi, PhD, MPH د. هادي ضناوي—alongside MENASA GROUP, Rethix & DiversiTrials—take the lead on these crucial DAP reviews. 👉 Why does this matter? This isn’t just another policy update. It’s a game-changer for clinical trial diversity, representation, and equitable healthcare. As someone who has been deeply involved in shaping the FDA DAP—including providing significant feedback to the FDA, engaging in OMB Directive 15, and advocating for its reinstatement under the Trump Administration and HHS—this is a HUGE WIN. 👏 YES, you’re welcome! Now, let’s get to work. 💬 What’s your take? How should we hold sponsors accountable under the reinstated DAP? Drop your thoughts below! ⬇️ #FDA #DiversityInClinicalTrials #ClinicalResearch #HealthEquity #RegulatoryAffairs #MENASAGroup #DiversiTrials

MUST READ! Hello, Bonjour, Hola, Marhaba! For those who may not have noticed, the FDA Diversity Action Plan (DAP) is back online. Given the agency's recent workforce challenges, I am proposing that Hadi Danawi, PhD, MPH د. هادي ضناوي MENASA GROUP Rethix & DiversiTrials take the lead on these DAP reviews. I have been personally involved with the OMB Directive 15, in providing significant feedback to FDA DAP and in discussion to re-instate DAP back with the Trump Administration and HHS. What A HUGE WIN. YES, you are welcome! Take a look: #FDA FDA

DiversiTrials was born in the Year of the Dragon🐉. We came in hot! Pushed for change, built connections, and did our best to make sure inclusion, diversity, and representation in clinical research wasn’t just a passing topic. Now, it's the Year of the Snake 🐍. This is a time for us to move with strategic intention. Less noise, more bite. This year, we are focusing on strengthening the right partnerships and making an impact where it actually matters. No matter what obstacles may be in the way, we’ll keep moving, adapting, and finding ways to push this mission forward. Change doesn’t happen by waiting; it happens by making it happen. See you out there! Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي #YearOfTheSnake #DiversiTrials #EquityInResearch #LessNoiseMoreBite

💔 In Memorium: FDA DAP Draft Guidance (June 2024 – January 2025) "Gone but not forgotten, this draft guidance graced our lives briefly before disappearing into the regulatory abyss." The FDA DAP draft guidance, once a beacon of insight for some and a curiosity for others, is no longer available on the FDA website. In the spirit of remembrance (and perhaps a touch of nostalgia), we are sharing the document for entertainment purposes only. https://lnkd.in/ei9_9ejQ 👉 Disclaimer: This document was previously available on the FDA website and has since been removed. It is shared here with full acknowledgment that it is no longer active or valid. Please note that this is not, in any way, official guidance, draft, or otherwise, from the FDA. It is intended purely for historical reference and should not be used for decision-making or professional purposes. #ResearchEquity #HealthEquity #Diversity #Inclusion #DAP #DoTheRightThing Mitchell Hilbe Hadi Danawi, PhD, MPH د. هادي ضناوي

Over the past several years, I have noticed a particular misinterpretation of Dr. Martin Luther King Jr.’s “I Have a Dream” speech. The line “judged by the content of their character, not the color of their skin” is often used to push a “colorblind” concept (which we know is just a way to try and ignore systemic racial inequalities) So… I want to highlight another line from Dr. King’s speech that I feel should be the resonating call to action. I also want to encourage everyone to remember these words and carry them with you through your work. “I have a dream that one day every valley shall be exalted, and every hill and mountain shall be made low,” Many of you may know that this is a direct echo of Isaiah 40:4. In this biblical verse, the prophet speaks of leveling the uneven ground to prepare the way of the Lord. A vision of equity, of righting the wrongs, and ensuring that no obstacles remained in order for righteousness to prevail. The dream of justice and equality isn’t handed down, it’s continually built through our collective effort. To exalt the valleys means we need to lift up the oppressed. To bring down the mountains means dismantling the systems of privilege and inequity that exist. We need to step into uncomfortable spaces and challenge the structures that divide us in order to create a level playing field. Whether you follow a biblical religion or not, if you truly believe in Dr. King’s dream, then your actions must match your words. Ask yourself the following: What valleys can I lift? What mountains can I bring low? And then get to work.

As 2024 fades into the horizon, we are grateful for everyone who has joined us on this journey to make clinical research more inclusive and equitable. This past year, we have laid important groundwork, built strong partnerships, and stayed true to our mission. In 2025, we are gearing up for bigger challenges and even greater progress. Thank you for riding alongside us! Together, we are all making a difference. Here’s to the trails and trials ahead! Love, DiversiTrials Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي #HappyNewYear #DiversiTrials #InclusionMatters

Kwanzaa is grounded in the Nguzo Saba (n-GU-zo SAH-bah)—seven guiding principles that highlight the importance of unity, purpose, and community. These principles align deeply with the work we do and the values we strive to embody every day. - Umoja (Unity) Efforts that seek to maintain unity whether in the family, the community, or the nation. - Kujichagulia (Self-Determination) Defining and speaking for ourselves, rather than being defined by or spoken for, by others. - Ujima (Collective Work and Responsibility) Working collectively to build-up the community and solve problems. - Ujamaa (Cooperative Economics) Supporting our businesses and entrepreneurial efforts so that our communities can thrive. - Nia (Purpose) Grounding our work and collective efforts in the purpose of restoring our traditional greatness. - Kuumba (Creativity) Generating beauty through creative and artistic endeavors that establishes mutual benefit to the community. - Imani (Faith) Having faith in the community power to be resilient even during the struggle for justice. “Habari Gani?” This phrase means “What’s the news?” and is used as a daily greeting during Kwanzaa. The response to this greeting is the principle of the day. This greeting helps to focus the celebration on the principle of the day and encourages reflection and discussion. We invite you to celebrate Kwanzaa with DiversiTrials over the next 7 days. Each day, remember to ask yourself “Habari Gani?” And reflect on the principle of the day. Love, DiversiTrials Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي #Kwanzaa #NguzoSaba #HabariGani #DiversityInResearch #HealthEquity https://lnkd.in/et_92Xj5.

As our communities light the menorah and celebrate the Festival of Lights, we are reminded of the power of resilience, hope, and unity. At DiversiTrials, we strive to embody these values by bringing light and inclusivity to clinical research, creating opportunities for all communities to participate and shine. Just as each candle adds brightness to the menorah, every voice and every story adds strength to our mission. Together, we can illuminate a path toward equity and trust in healthcare. From our family to yours, may your Hanukkah be filled with warmth, joy, and the company of loved ones. Chag Sameach! 🕎 Love, DiversiTrials Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي #HappyHanukkah #FestivalOfLights #InclusivityInResearch #MajorLeagueDreidelTournamentTime

Season of Gratitude: Day 7 We are wrapping up our 7 days with being grateful for the future. As we celebrate this holiday season, we are grateful for the hope, opportunities, and all the possibilities that the future holds. We are looking forward to 2025 with you all 🫶 Merry Christmas! Love, DiversiTrials Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي

Season of Gratitude: Day 6 Today, we want to express our gratitude for Teamwork. Our team is the heart of everything we do, and we couldn't be more grateful for the passion and dedication they bring to our mission every day. Thank you for making it all possible! Have a safe and joyous Christmas Eve! ❤️ Inclusion Advisory Board Team ❤️ Raven Hicks, M.S., Kailee Kenwright, Ljiljana Minwalla, J.D., Ph.D., Tina (Weldt) Karunaratne, Raghav Mohindra MD Love, DiversiTrials Mitchell Hilbe & Hadi Danawi, PhD, MPH د. هادي ضناوي