Mark Fischer’s Post

The FDA has released new guidance on Diversity Action Plans to enhance the enrollment of participants from underrepresented populations in clinical studies. This step is crucial to ensure trial populations mirror the real world. However, there are still some key areas where improvement is needed: 1. Loose Criteria for Waivers 2. Limited Scope 3. Global Considerations 4. Non-binding Nature 5. No Consequences for Missing Goals 6. Limited to Phase III What are your thoughts? #ClinicalResearch #DiversityInResearch

Championing Diversity in Clinical Trials: A Crucial Step Forward The recent FDA guidance on Diversity Action Plans is a pivotal moment in our mission to ensure that drug and device development truly reflects the diverse needs of all patients. Embracing patient diversity is not just a regulatory requirement—it’s a fundamental aspect of delivering equitable healthcare. Did you know that historically, certain patient groups have been significantly underrepresented in clinical trials? For example, African Americans represent only 5% of clinical trial participants, while Hispanic/Latino populations account for just 1%. Are you ready to integrate these essential plans into your clinical trials? Together, we can enhance the inclusivity and representativeness of our studies, ultimately leading to better health outcomes for every patient. Let’s spread the word and make a difference! Share this message with your network and join me in championing diversity in clinical trials. #DiversityInClinicalTrials #ClinicalResearch #Diversity #Equity #Healthcare https://lnkd.in/gXy_iAuv

Diversity, Equity, and Inclusion (DEI) in clinical trials are crucial to ensuring that new treatments work effectively across diverse populations. Regulatory bodies, like the FDA, play a significant role in promoting DEI by guiding the inclusion of underrepresented groups in clinical research. The FDA's 2020 Guidance for Industry on Enhancing the Diversity of Clinical Trial Populations outlines key strategies to achieve this goal. It emphasizes the importance of: Broadening Eligibility Criteria: Ensuring trial participants reflect the real-world patient population, including those with varying health conditions and demographic factors. Reducing Participation Barriers: Implementing trial designs that reduce participant burden by using flexible visit schedules, remote monitoring, and mobile medical professionals. Inclusion Strategies: Encouraging the involvement of underrepresented racial, ethnic, and gender groups to ensure that trial data adequately reflects the needs of the broader population. This guidance is a crucial step in addressing health disparities and ensuring that clinical trials lead to equitable healthcare outcomes for all. For more details, check out the full FDA guidance here: #ClinicalTrials #DEI #Diversity #RegulatoryAffairs #FDA #HealthEquity

Diversity Action Plans are soon to be required for certain clinical studies. Starting from June 2025, sponsors must submit these plans to the FDA to ensure the inclusion of underrepresented populations (1). For personalized advice and to get started on your Diversity Action Plan, reach out to ClinQure at hello@clinqure.com. Our experts are here to help you navigate these new requirements and advance healthcare inclusively. 1: https://zurl.co/7J2ab

There is no rhyme or reason that racial, ethnic, sex, gender, age, etc make up of patient populations shouldn't be reflected in clinical trials that test drugs, devices, procedures in those patients, but that is our history. We've done so poorly at ensuring trials represent real world patient populations that so many times we don't know if a drug would be effective in a female or in a child, for example. DEI in clinical trial design ensures that we can have confidence in the results of the trial because the intervention was tested on adequately representative patients.

The recent decision to remove information regarding clinical trial diversity and health equity from the FDA website is concerning. Despite this setback, the industry's focus on clinical trial strategies and equity priorities is unlikely to shift significantly. The emphasis on diversity, equity, and inclusion is not solely driven by altruism; it is also a sound business practice. As Eleanor Roosevelt aptly stated, "When it's better for everyone, it's better for everyone."

MEDIcept Minute: FDA’s Center for Device’s and Radiological Health (CDRH) Device Trial Participation Snapshots On Tuesday, October 15th, the FDA announced that the CDRH will pilot providing device trial participation snapshots intended to give consumers and health care professionals key information related to clinical trials, supporting the FDS’s approval of new medical devices. This news comes as an overall effort by FDA to increase transparency related to clinical trials for medical products and diversity in clinical trial participation. Furthermore, it supports CDRH’s efforts to advance health equality. For more information, see the link below. https://lnkd.in/dVUi6Bb3 The CDRH is seeking comments from the public until January 13th, 2025. Are you interested in learning more about how MEDIcept can assist in your next clinical trial? Email us today at sales@medicept.com. #FDA #CDRH #MedicalDevices #ClinicalTrials #Clinical 

📢 MRCT Center Public Comment Submission The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) recently submitted public comments to the FDA on its draft guidance for Diversity Action Plans (#DAPs), highlighting key areas where transparency and clarity are needed. Our comments emphasize the importance of clear FDA feedback timelines and assessment criteria for community engagement, site selection, recruitment, enrollment, and retention plans, both domestically and globally. We also recommend: Clarifying DAP requirements for Phase 3 trials (new and previously approved products), Implementing a “do no harm” approach for global participants, Considering when to disaggregate US and global enrollment goals/data. To improve the guidance, we suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations toward effective diversity strategies. ➡️ Click here to read the public comments: https://bit.ly/4eteYIP #ClinicalTrials #DiversityInResearch #GlobalTrials #InclusiveResearch #CommunityEngagement #DAP #InclusionInScience

Are you prepared to meet the FDA's upcoming requirements on Diversity Action Plans for clinical trials?  Get ahead of the curve with WCG! Join experts Emery Brandy, Olga Balderas, and Amy Thue for part one of this two-part diversity webinar series as they delve into key topics, including: 🔍Overview of the FDA guidance on Diversity Action Plans for clinical trials. 🔍The impact of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act passed by U.S. Congress. 🔍Actionable recommendations for sites, sponsors, and CROs to improve DEI implementation. Discover how to improve enrollment of participants from underrepresented populations in your studies. Register now for our upcoming webinar at https://lnkd.in/eiFYWU84 #WCG #webinar #clinicalresearch #DEI #FDA #diversity #clinicaltrial

 Raven Clinical Research Applauds FDA's New Diversity and Inclusion Guidance for Clinical Trials At Raven Clinical Research, we commend the FDA's new diversity and inclusion guidance that will require sponsors to submit diversity action plans for Phase 3 and pivotal trials. As Commissioner Robert M. Califf stated, "achieving greater diversity will be key to developing better treatments for diseases that disproportionately impact diverse communities." Representing the real-world population is vital for generating meaningful trial results. We're proud to embrace solutions that bring us closer to fully inclusive and equitable clinical research benefiting all communities. Diversity and inclusion aren't check-boxes - they're imperative for developing safe, effective therapies. The new FDA guidance is a positive step, and Raven Clinical Research stands ready to advance this important mission. Read more about meeting the diversity challenge head-on. https://lnkd.in/gfDWJXdE #ClinicalTrialDiversity #InclusiveResearch #EquitableHealthcare #DiversityInnovation #FDAGuidance #PatientCentricTrials #RepresentativeData