Altasciences’ Post

📑 Find this #FDA guidance on #DiversityActionPlans to support #MedicalProductSponsors in their submission process. #DiversityActionPlans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. Find out more 👇 #FDA #ClinicalStudy #Agency #MedicalProduct

🌟 Exciting News! The FDA’s New Diversity Action Plans Guidance for Clinical Trials Are Here! We’ve eagerly awaited this moment for the past seven months, and it’s finally here! The FDA has released its long-anticipated guidance on Diversity, Equity, and Inclusion (DEI) in clinical trials, and Reveles Clinical couldn’t be more thrilled. At Reveles, we firmly believe that diverse and inclusive clinical trials are essential for ensuring that new therapies are safe and effective for all patient populations. This landmark guidance aligns perfectly with our mission to enhance patient engagement through innovative AI solutions and collaborative efforts with our sponsor partners. Why This Matters: Equity in Healthcare: The new guidelines will ensure that clinical trials better represent the diverse populations using the treatments. Improved Outcomes: Diverse participation can lead to more comprehensive data and better, more personalized healthcare solutions. Increased Trust: By prioritizing DEI, we can build greater trust within underrepresented communities, ensuring they feel valued and heard. We are excited to partner with our sponsors to turn these guidelines from insights into actionable strategies. Together, we will develop and implement practices that promote inclusivity and equity, ultimately enhancing the quality and reach of clinical research. Next Steps: Collaboration: We will work closely with our sponsor partners to integrate these DEI guidelines into all aspects of clinical trial design and execution. Education & Training: Providing ongoing education and training for our team and partners to ensure a deep understanding of DEI principles and their application. Technology & Innovation: Leveraging our cutting-edge AI technology to identify and overcome barriers to participation, ensuring a more inclusive approach to clinical trials. We invite our network to join us in this vital journey toward a more equitable future in clinical research. Together, we can make a difference, one trial at a time. Let’s move from insights to actions and create a lasting impact in the world of clinical trials. 🌍💪 #DEI #ClinicalTrials #FDA #Reveles #HealthcareInnovation #PatientEngagement #EquityInHealth

The draft guidance the FDA released today is another important step towards health equity! "This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as the timing and process for submitting Diversity Action Plans to the FDA." The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guidance. Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov.

H1’s recent blog post highlighted how “Around 20% of drugs affect people differently due to race.” This new guidance will help to address this #healthequity problem, as well as others. H1’s Trial Landscape product can help you successfully implement the FDA’s new guidance on diversity action plans. Reach out to learn more! #clinicaltrials #fdaguidance #diversityactionplan

A great step closer to equity and inclusion in research. Learn more 👇🏼

A very welcome development. It wasn't that long ago, at our most recent company offsite, that Asmaa Foda and I spoke about 'Inclusive Trials for Inclusive Care'. We touched on: 😓 An overview of the sometimes frankly shocking and troubling history of under-representation in research and the resulting fundamental undermining of trust 👀 The WEIRDness of most research participants (Western, Educated, Industrialised, Rich, Democratic) 📉 The Inverse Care Law reframed to become the Inverse Research Law (those who most need to be represented in the research are the least likely to be) This guidance from the FDA is certainly a step in the right direction and it's much needed. Just take a look at this Nature Portfolio Digital Medicine News & Views piece by Stephen Gilbert, Kaushik Venkatesh & Kushal Kadakia on 'the first AI-enabled skin cancer device for primary care authorized by FDA'. It's difficult not to be shocked by this paragraph: "FDA has imposed requirements for post-market performance testing in underrepresented populations, as notably 97.1% of patients in the pivotal DERM-SUCCESS trial were of White race and only 13% were from the most pigmented skin types" I wonder whether these guidelines, if in place, would have significantly changed the data gathering approach here or whether manufacturers will just reach for the waiver option?

The FDA recently launched the Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors. YPrime can help with your #eConsent needs, and ensure your trial is compliant with the new regulations. Read the guidance document to understand the potential implications on your clinical trials: https://hubs.ly/Q021kbqt0. Explore our eConsent capabilities: https://hubs.ly/Q021km8m0

The FDA has issued their draft guidance regarding Diversity Action Plans and is encouraging comments to be submitted by 26 Sep 2024. It replaces the draft guidance for industry entitled “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials,” published April 14, 2022. There cannot be true innovation without representation. I will certainly take the time to pour over the draft, and I highly encourage others to do the same. There is still so much ground to cover in creating clinical research that is comprehensive, and while this guidance is only one part of that, it is hopefully an important step in the right direction. #Diversity #HealthEquity #ClinicalResearch #ClinicalTrials

'For drugs, a Diversity Action Plan is required for a clinical investigation of a new drug that is a phase 3 study (as defined in 21 CFR 312.21), or as appropriate, another pivotal clinical study of a drug (other than a bioavailability or bioequivalence study). For devices, a Diversity Action Plan must be included in the Investigational Device Exemption (IDE) application for clinical studies of the device. An IDE application is required if the sponsor intends to use a significant risk (SR) device (as defined in 21 CFR 812.3(m)) in an investigation, intends to conduct an investigation that involves an exception from informed consent under 21 CFR 50.24, or if FDA notifies the sponsor that an application is required for an investigation. For devices for which an IDE application to FDA is not required, except for a device being studied as described in 21 CFR 812.2(c), section 520(g)(9)(A)(ii) requires sponsors to develop a Diversity Action Plan for any clinical study with respect to the device. Diversity Action Plans for these devices must be submitted to FDA in any premarket notification, request for classification, or application for premarket approval under section 510(k), 513(f)(2), or 515 of the FD&C Act, respectively.' The latest FDA guidance on diversity plans. If you have not started thinking about diversity plans now is the time. #FDA #diversityplan #medicaldevices #clinicaltrials #pharmaceuticals

True inclusion is so critical when it comes to clinical research. We need to be sure the studies we are recruiting for are truly representative of the patient populations that are impacted and could potentially benefit from these interventions. It will be important for sponsors to carefully consider the upfront research on the demographics that are impacted prior to planning their recruitment efforts, and Antidote Technologies is ready to help the industry to meet these goals.