New FDA Guidance Unveiled: Blueprint for Breaking Barriers Big and exciting clinical trial update: The FDA has recently issued its draft guidance on clinical trial diversity, detailing requirements for racial and ethnic diversity action plans. This comprehensive document outlines how to format and submit these plans, emphasizing recruitment goals aligned with disease prevalence. Companies are expected to set recruitment goals for various racial groups, categorized by age and gender, and to explain their rationale and strategies for achieving these goals. This initiative aims to improve representation in clinical trials and enhance the validity of safety and efficacy studies. In what ways do you think the FDA's new draft guidance on clinical trial diversity will influence the development and approval processes of medical products in the future? How can companies adapt their recruitment strategies to align with the FDA's new guidelines? “Participants in clinical trials should be representative of the patients who will use the medical products,” says Robert Califf, the FDA commissioner. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.” Read more in the article in the comment below. #FDA #ClinicalTrials #DiversityInResearch #HealthcareEquity #MedicalResearch #FDAguidance #InclusiveTrials #PatientRepresentation #HealthcareDiversity #ResearchDiversity #TrialRecruitment
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DEMYSTIFYING CLINICAL TRIALS ▸ Every year, thousands of clinical trials across the globe play an essential role in advancing our understanding of medical therapies. These trials are not merely regulatory requirements; they are crucial phases in the lifecycle of drug development, providing key insights into the efficacy and safety of prospective treatments. 💡But what's actually involved with a clinical trial? Discover more below about the vital role of clinical trials in healthcare innovation and how they pave the way for new treatments to reach those in need. The article explores questions and topics like: 🌐 What is a clinical trial? 🎯 Why are clinical trials important? 🌍 The global landscape of clinical trials and key areas of focus 🔄 The phases of clinical trials 🔗 The future of clinical trials including the impact of technology #ClinicalTrials #MedicalResearch #PatientCare #Innovation #Healthcare #Akesa #ClinicalTrialSupplies
Clinical trials explained | Akesa
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This is an exciting move by Pfizer! Participants in Pfizer-sponsored clinical trials now have the unique opportunity to access their individual data approximately 12 months post-trial completion. Sharing data transparently is foundational to creating patient-centered trials. This initiative not only fosters patient empowerment but also contributes to the evolution of clinical trials into more patient-centric and responsive endeavours. Thoughts? #ClinicalTrials #PatientCentricity
The Importance of Returning Clinical Trial Data to Participants | Pfizer
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THREE (3) BENEFITS OF PARTICIPATING IN CLINICAL TRIALS. 1. Finding Novel Treatments Clinical trials are essential in advancing medical discoveries from the researchers to the patients. The data collected during trials evaluate the effectiveness and safety of an investigational product, which determines if the product should be approved by the US Food and Drug Administration (FDA) or similar regulatory authorities for use by the public. Importantly, these trials will only happen with the participation of healthy volunteers or patients. In addition, you will have access to a first-class medical team that carefully monitors your progress and overall health. 2. Get Help and Help Others by Saving Lives Participating in clinical trials is necessary to help prevent, diagnose, and find cures for diseases and illnesses. Your participation in clinical trials could contribute to the link between research and bringing life-saving therapies to patients. For example, if you have a genetic disease or illness, your participation could have an immense impact personally. You could also be helping sick people with similar genetic makeup to get novel treatment options. 3. Get Treated by the Best Medical Practitioners Remember that whenever you actively participate in a clinical trial, your care is monitored by your doctor and highly-trained clinical research staff members. They look at every health parameter worth looking at, including labs, drugs, symptoms, and data collection processes, and carefully interrogate the impact on you, your care, and your outcome. They adhere to study protocols, ensuring lab testing and study procedures are executed with utmost precision and in line with standard guidelines for conducting research in humans. It takes a well-trained team of research professionals to keep a clinical trial running smoothly. At Bispharm Clinical, patient-centricity is our watchword. All our services are tailored to ensure you get the best out of your participation. #Bispharmclinical #Studyparticipant #Clinicaltrials #Patientrecuitment #Clinicalresearch #Clinicaltrialsitemanagement #SMO
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Enhancing patient diversity in #ClinicalTrials has become a key priority in #DrugDevelopment. To learn more about the latest expectations for enhancing clinical trial diversity, we interviewed Rose Blackburne, MD, MBA, vice president and global head of general medicine and women’s health at the PPD Clinical Research Units business of Thermo Fisher Scientific. In the following interview, Dr. Blackburne discusses the latest #regulatory requirements around diversity in clinical trials, how the industry is responding and what actions will help enable further progress in clinical trial #HealthEquity in the years ahead: Clinical trial diversity: https://lnkd.in/ewPfDMFh #ClinicalDevelopment #pharma
Clinical trial diversity: Interview with Dr. Rose Blackburne
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Director of Clinical Research Operations @ the University of Pennsylvania- Abramson Cancer Center Clinical Research Unit
Today, the FDA issued: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies – DRAFT Guidance June 2024 This draft guidance describes the form, content, and manner of diversity action plans, the applicable medical products, and clinical studies for which a diversity action plan is required, the timing and process for submitting diversity action plans, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit a Diversity Action Plan. 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. https://lnkd.in/eTEEMKv7
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Draft Guidance for Industry
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It's easy for drug development companies to say they're committed to supporting the patient engagement movement – but research shows otherwise. A recent survey from Tufts University shares that of several hundred companies polled, only 27% are routinely soliciting patient input into protocol design decisions. Aside from that, a recent CISCRP study found: ◾ Only 35% of clinical trial volunteers report receiving a formal verbal or written “Thank You." ◾ Less than 30% of clinical trial volunteers report receiving any information about the results of their clinical trial. If you want to become more patient-centric but don't have the bandwidth, resources, or know-how, we'd love to help. You can connect with us here: https://lnkd.in/gt6hD3Mn #patientsupport #patientcentricity #patientfocused
Calling Out ‘Check-the-Box’ Patient Engagement
appliedclinicaltrialsonline.com
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Biomedical Engineering Professional/Leader, with Expertise in SDLC and Experience in Bioinformatics, SaMD, SiMD, Digital Health, Precision Medicine, and Global Health (Quality Matters to Deliver Great Products)
Including diversity in clinical studies has long been a topic of discussion within the medical community. The importance of this issue is further elaborated in a perspective published on NEJM Group. One notable example highlighting the impact of diversity on clinical accuracy involves the influence of skin color on the outputs of pulse oximetry, detailed in recent publications. Notably, the US FDA recently released a draft guidance titled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." This guidance aims to standardize study design, potentially aligning practices with new regulatory provisions. Some manufacturers have already incorporated these requirements into their operations, showcasing proactive measures in this area. The guidance outlines the format and content of Diversity Action Plans, emphasizing the need for sponsors to specify enrollment rationale and goals across various demographic factors. It also encourages a comprehensive approach to diversity beyond traditional categories, ensuring representation of the patient populations that may benefit from approved products. While the focus is currently on US markets, aligning these requirements internationally presents an intriguing challenge. Aligning epidemiologically with conditions treated by products across diverse markets adds further complexity to this goal. Furthermore, the guidance holds promise for digital health applications, ensuring efficacy and benefit alignment with user needs. For more information: - NEJM perspective: https://lnkd.in/ghRnRRKZ - FDA draft guidance details: https://lnkd.in/gR2kKEef - Pulse Oximetry discussion on NEJM: https://lnkd.in/gUBMTYZw - FDA Executive Summary for Pulse Oximetry Investigation: https://lnkd.in/ghRu2-H4 - Relevant report from Fierce Biotech: https://lnkd.in/gC3afHU9 - Relevant report from MedTech Dive: https://lnkd.in/gwjhZ6kz #clinicalstudy #clinicaltrial #clinicalevaluation #biomedicalengineering #Quality #Regulatoryaffairs #medicaldevices #digitalhealth #SaMD #SiMD #Medtech #Biotech #FDA #IVD #POC #clinicalevaluationstudy #standards #guidance #diversity #CRO #Research #PolicyRegulation #Planning #clinicalresearch #precisionmedicine #precisionhealth
FDA shares draft guidance on clinical trial diversity action plans
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𝐓𝐡𝐫𝐞𝐞 𝐊𝐞𝐲𝐬 𝐭𝐨 𝐈𝐦𝐩𝐫𝐨𝐯𝐢𝐧𝐠 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 Clinical research should be a viable option for everyone who wishes to participate. Sponsors know that diverse trials lead to stronger data and better drugs. With some promising news from regulatory bodies wanting to address the issue of diversity in clinical trial, evidenced by the Food and Drug Omnibus Reform Act being enacted last year, which required sponsors of any phase 3 trial to submit a diversity action plan. However progress in increasing diversity is still slow, but here are some of the key elements sponsors need to think about to drive diversity. More targeted recruitment through cleaner data. How we manage patient records in traditional healthcare settings will enable an accurate, holistic picture of a patient, creating an accurate profile to compare against inclusion and exclusion criteria for trials. Advancing Transparency and Accessibility Surrounding Research, Beyond identifying the right patients, there is inequity in which patients are given the opportunity to participate. For many, clinical research can be a final, lifesaving option of care. Improving convenience and engagement, The personal and financial cost of participating can also be limiting factors. Garnering interest from diverse participants requires meeting them where they are with flexible research options that allow them to fit a clinical study seamlessly into their work and family life. For more follow the article below. https://lnkd.in/eCR453_W
Three Keys to Improving Diversity in Clinical Trials
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Experienced Leader in Operations and Health Equity | Innovator in Kidney Disease Management | VBC| Advocate for Addressing Social Determinants of Health and Transforming Standards of Care | Non-Clinical Dialysis SME
How to improve patient outcomes by decreasing the I/E criteria in clinical trials. Are pharmaceutical companies, sites and CROs addressing this?? 1. Simplify Eligibility Criteria: Streamline and simplify the inclusion/exclusion criteria in clinical trials to ensure broader access for patients. Eliminate unnecessary restrictions and focus on the core requirements that are essential for the study objectives, safety, and efficacy. 2. Expand Age and Comorbidity Inclusion: Broaden the age range and consider including patients with common comorbidities that are representative of the real-world population. This expansion will enhance the external validity of trial results and improve equal access to clinical trials for a wider patient population. 3. Embrace Real-World Evidence: Incorporate real-world evidence (RWE) into the trial design by leveraging electronic health records, patient registries, and observational studies. RWE can provide valuable insights into patient reported outcomes and help identify potential participants who may not meet traditional eligibility criteria but could still benefit from trial participation. 4. Enhance Patient-Centric Trial Design: Involve patient representatives and advocacy groups in the trial design process. Their input can help identify and modify criteria that may unintentionally exclude certain patient populations, promoting equal access and ensuring patient reported outcomes are meaningful and relevant. 5. Utilize Adaptive Trial Designs: Implement adaptive trial designs that allow for modifications in eligibility criteria based on accumulating data. This flexibility enables the inclusion of a broader patient population throughout the trial, leading to more representative patient reported outcomes. 6. Increase Diversity in Trial Recruitment: Actively promote diversity and inclusion in trial recruitment efforts. Collaborate with community organizations, healthcare providers, and patient support groups to reach underrepresented populations. This strategy will help address disparities and ensure equal access to clinical trials. #InclusionExclusionCriteria #EqualAccess #PatientReportedOutcomes #ClinicalTrialDelivery #RealWorldEvidence #PatientCentric
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Link to the article: https://www.fiercebiotech.com/cro/fda-publishes-updated-draft-guidance-clinical-trial-diversity-drug-devices-studies