Please join us on Tuesday, June 25, for an educational webinar hosted by Andrew Holt, PharmD, BCMAS, CPGx, Clinical Pharmacist, Aegis Sciences Corporation. Dr. Holt will discuss new data on Nitazenes, an emerging threat. Register Today: https://lnkd.in/ejtCHFuc #AegisLabs #AegisEducates #Nitazenes #NPS #DesignerOpioids #OnePillCanKill #LivePresentation #Webinar #Education #PublicSafety
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The long awaited (draft) FDA Guidance for Diversity in clinical trials is here! I was so proud to lead this workstream at Click Therapeutics, Inc. and to continue the mission now at 1nHealth, where we can reach more potential trial participants (in number and in diversity) than ever with digital marketing. I look forward to seeing the industry make strides toward truly equitable and representative trials! Reach out it you want to discuss the draft guidance or collab to submit comments! 📱🤝🌎 #DEI #clinicaltrials #patientrecruitment #diversity #diversityactionplan #fda
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Innovator | Strategist | Advisor | Consultant | Board Member | Clinical Executive | Regulatory Affairs | Clinical Affairs | Scientific Affairs
If you plan to conduct clinical trials, read on! The FDA draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (June 2024) outlines recommendations for enhancing diversity in clinical trials. Based on my regulatory experience, key points include: 1) The guidance aims to improve enrollment of underrepresented populations in clinical studies. 2) It identifies studies that should have diversity action plans. 3) It explains the content of the Diversity Action Plan: ● Enrollment Goals: Sponsors should set specific goals for participant diversity. ● Rationale for Enrollment Goals: Sponsors must explain the rationale behind these goals. ● Measures to Meet Enrollment Goals: Strategies to achieve diversity should be outlined. ● Timelines for Submitting Diversity Action Plans: Guidance on when to submit these plans. ● Procedures for Submission and Feedback: How to submit plans and receive feedback. ● Requesting Diversity Action Plan Waivers: Information on waivers. ● Sponsor Public Posting of Key Information: Encourages transparency. #FDA #regulatoryaffairs #clinicaltrials #clinicalresearch #regulatory #equity #diversity #inclusion #EDI #DEI
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Experienced Clinical GCP auditor (Internal, ISA, PV, TMF, and Vendor) with experience in quality management role (R&D, Clinical Quality, Quality Compliance) in support of clinical trials.
Start taking this into consideration now.
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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I help digital health-enabled organizations intelligently navigate risk and expenses linked to non-compliance and under-optimized workflows.
We need more diversity and clinical trials This draft is a good step forward in terms of improving enrollment and underrepresented populations I look forward to seeing some of this implemented so that we can create solutions for individuals from diverse backgrounds Does anything stand out to you in this draft? #fda #clinicaltrials #evidencebasedmedicine #healthequity #eliminatedisparities
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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🎉 Exciting News! 🎉 The US FDA released today the draft guidance for Clinical Trial Diversity Action Plan. Being a proud member of the Latino population, I can attest to how much representation matters! This step is crucial for making clinical trials more inclusive, safe and effective to all of us. Some key highlights: 📊 **Data Collection**: Sponsors must set specific enrollment goals by age, ethnicity, sex, and race. 📈 **Strategic Planning**: Encourages consideration of all diversity dimensions in trial designs. 🔬 **Health Outcomes**: Leads to broader applicability and better understanding of treatments. 💼 **Regulatory Framework**: Required for certain phase 3 and pivotal studies starting 180 days after final guidance. Let’s continue working together to reflect the populations we serve. #ClinicalResearch #DiversityInResearch #FDA #HealthEquity #DiversityActionPlan
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Senior Associate, Health Specialist @ VOZ Advisors | Patient Advocacy | Patient Engagement | Public Health | Health Equity
📑 Yesterday, the #FDA published its DRAFT #guidance to improve enrollment of historically marginalized communities in clinical research. As stated in the press release, "The requirement for sponsors to submit Diversity Action Plans comes from new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA). These plans apply to phase 3 clinical studies or, as appropriate, other pivotal clinical studies of a drug or biological product, as well as for certain clinical studies of devices, including those intended to serve as the primary basis for the FDA’s evaluation of the safety and effectiveness and benefit-risk determination of the device. The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guidance." Fore more information on the draft guidance and how to submit comments visit https://lnkd.in/gWyDuKnG
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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PolicyMap is proud to support BioPharma and CROs in this mission. Our platform offers comprehensive demographic, socioeconomic, and social determinants of health data, enabling researchers to identify and engage diverse populations effectively, enhance recruitment strategies, and ensure representation across all communities. Contact us today for a one-on-one tutorial! The FDA has released the widely anticipated draft guidance on "diversity in clinical trials," emphasizing inclusive participation in drug and device studies. The guidance requires diversity action plans detailing recruitment goals and strategies such as community engagement and decentralized trials. These requirements will be mandatory 180 days post-final publication.💡 Read the full FDA guidance here: https://lnkd.in/gNczUwNA #ClinicalTrials #Diversity #BioPharma #CRO #FDA #HealthEquity #ResearchInnovation #HealthData #SDOH
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Good to see this guidance issued!
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Assessing the impact of social determinants of health on safety and efficacy of health products during clinical trials would be a fundamental step forward. Waiting for the next update. Where is the EU?
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
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Global Executive Marketing Operations Stream Leader | CSR Member Committee | FemTech Ambassador @PQE Group
🌟 Exciting News from the FDA! 🌟 The U.S. Food and Drug Administration issued a groundbreaking draft guidance titled “𝓓𝓲𝓿𝓮𝓻𝓼𝓲𝓽𝔂 𝓐𝓬𝓽𝓲𝓸𝓷 𝓟𝓵𝓪𝓷𝓼 𝓽𝓸 𝓘𝓶𝓹𝓻𝓸𝓿𝓮 𝓔𝓷𝓻𝓸𝓵𝓵𝓶𝓮𝓷𝓽 𝓸𝓯 𝓟𝓪𝓻𝓽𝓲𝓬𝓲𝓹𝓪𝓷𝓽𝓼 𝓯𝓻𝓸𝓶 𝓤𝓷𝓭𝓮𝓻𝓻𝓮𝓹𝓻𝓮𝓼𝓮𝓷𝓽𝓮𝓭 𝓟𝓸𝓹𝓾𝓵𝓪𝓽𝓲𝓸𝓷𝓼 𝓲𝓷 𝓒𝓵𝓲𝓷𝓲𝓬𝓪𝓵 𝓢𝓽𝓾𝓭𝓲𝓮𝓼.” This initiative aims to enhance the enrollment of historically 𝐮𝐧𝐝𝐞𝐫𝐫𝐞𝐩𝐫𝐞𝐬𝐞𝐧𝐭𝐞𝐝 𝐩𝐨𝐩𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐢𝐧 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐢𝐞𝐬, ensuring more comprehensive and #inclusive #data collection. Key Highlights: 🔹 Diversity Action Plans are now a requirement for certain 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐬𝐭𝐮𝐝𝐢𝐞𝐬, driven by new provisions under the Federal Food, Drug, and Cosmetic Act. 🔹 These plans will target #diversity in terms of 𝐚𝐠𝐞, 𝐞𝐭𝐡𝐧𝐢𝐜𝐢𝐭𝐲, 𝐬𝐞𝐱, 𝐚𝐧𝐝 𝐫𝐚𝐜𝐞, aiming to better represent the populations who will use these medical products. 🔹 The guidance also encourages consideration of additional dimensions of #diversity, promoting a truly #𝐢𝐧𝐜𝐥𝐮𝐬𝐢𝐯𝐞 𝐚𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬. 🔹 This step is part of the FDA’s broader efforts to ensure that clinical trials 𝓪𝓬𝓬𝓾𝓻𝓪𝓽𝓮𝓵𝔂 𝓻𝓮𝓯𝓵𝓮𝓬𝓽 𝓽𝓱𝓮 𝓭𝓲𝓿𝓮𝓻𝓼𝓮 𝓹𝓪𝓽𝓲𝓮𝓷𝓽 𝓹𝓸𝓹𝓾𝓵𝓪𝓽𝓲𝓸𝓷𝓼 𝓲𝓷 𝓷𝓮𝓮𝓭 𝓸𝓯 𝓷𝓮𝔀 𝓽𝓻𝓮𝓪𝓽𝓶𝓮𝓷𝓽𝓼. Quoting FDA Commissioner Robert M. Califf, M.D.: “𝑃𝘢𝑟𝘵𝑖𝘤𝑖𝘱𝑎𝘯𝑡𝘴 𝘪𝑛 𝑐𝘭𝑖𝘯𝑖𝘤𝑎𝘭 𝘵𝑟𝘪𝑎𝘭𝑠 𝑠𝘩𝑜𝘶𝑙𝘥 𝘳𝑒𝘱𝑟𝘦𝑠𝘦𝑛𝘵 𝘵ℎ𝘦 𝘱𝑎𝘵𝑖𝘦𝑛𝘵𝑠 𝘄𝗵𝗼 𝘄𝗶𝗹𝗹 𝘂𝘀𝗲 𝘁𝗵𝗲 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀. 𝘛ℎ𝘦 𝘢𝑔𝘦𝑛𝘤𝑦’𝑠 𝑑𝘳𝑎𝘧𝑡 𝑔𝘶𝑖𝘥𝑎𝘯𝑐𝘦 𝘪𝑠 𝑎 𝑐𝘳𝑢𝘤𝑖𝘢𝑙 𝑠𝘵𝑒𝘱—𝘢𝑛𝘥 𝘰𝑛𝘦 𝘰𝑓 𝑚𝘢𝑛𝘺 𝘰𝑛𝘨𝑜𝘪𝑛𝘨 𝘦𝑓𝘧𝑜𝘳𝑡𝘴—𝘵𝑜 𝑖𝘯𝑐𝘭𝑢𝘥𝑒 𝑢𝘯𝑑𝘦𝑟𝘳𝑒𝘱𝑟𝘦𝑠𝘦𝑛𝘵𝑒𝘥 𝘱𝑜𝘱𝑢𝘭𝑎𝘵𝑖𝘰𝑛𝘴 𝘪𝑛 𝑐𝘭𝑖𝘯𝑖𝘤𝑎𝘭 𝘵𝑟𝘪𝑎𝘭𝑠 𝑎𝘯𝑑 𝑖𝘮𝑝𝘳𝑜𝘷𝑒 𝑡𝘩𝑒 𝑑𝘢𝑡𝘢 𝘢𝑏𝘰𝑢𝘵 𝘱𝑎𝘵𝑖𝘦𝑛𝘵𝑠 𝑤𝘩𝑜 𝑤𝘪𝑙𝘭 𝘶𝑠𝘦 𝘵ℎ𝘦 𝘱𝑟𝘰𝑑𝘶𝑐𝘵𝑠 𝑖𝘧 𝘢𝑝𝘱𝑟𝘰𝑣𝘦𝑑.” For medical product sponsors, this means a more structured and thoughtful approach to study design, ensuring diverse patient populations are considered from the start. This initiative is expected to provide valuable insights, improving the safe and effective use of medical products across all demographics. Let's champion #diversity and #inclusivity in clinical studies to create better, safer, and more effective medical solutions for everyone. 🌍💊✨ #FDA #ClinicalTrials #DiversityInResearch #HealthcareInnovation #InclusiveResearch https://lnkd.in/d5i7tJbG
FDA published a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies”: https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests To learn more about this guidance and how to submit comments, visit: https://lnkd.in/eT5AhNTP
