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Although we all recognize the under-representation of some populations in clinical trials and the value of having more representative studies, we continue to struggle to increase clinical study diversity. The report identifies major barriers to achieving a diverse clinical trial population across different demographic and non-demographic groups and suggests ways to overcome these barriers. Common obstacles include lack of community engagement critical for developing trust and facilitating diverse enrollment and retention, restrictive eligibility criteria, and logistical (usually attached to budget) issues. Achieving meaningful diversity in clinical trials is a multifaceted challenge that requires intentional, coordinated efforts across the entire clinical trial ecosystem. The difficulty of this endeavor is matched by the significance of its impact, as increasing diversity and representation in clinical trials will not only enhance the effectiveness and safety of drugs but also foster trust within underrepresented populations, making strides towards a more equitable future in medical research. https://lnkd.in/eU7-rZgp The APPENDIX section also provides a valuable source of guidance documents.

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 Notably, the US FDA recently released a draft guidance titled "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies."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

Patient Focus is a corporate, enterprise imperative and flows through clinical development from there. One approach that holds great promise for development stage companies is for Program Team leadership to take the lead and develop and commit to a patient/ advocacy engagement plan with shared development and corporate reputational objectives. Corporate Communications can be a great partner. Companies can start by making sure program teams are intimately connected with the patient experience.

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 

Great News in Clinical Trials! The FDA has just released new guidance on Diversity Action Plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. This supports progress toward ensuring that clinical trials are more inclusive and reflective of our diverse society. At Leapcure, we are fully aligned with making a difference in this area. Our aim is to bring gravity to all voices and incorporate empathy with everyone—from patients and advocacy groups to research sites and sponsors—ensuring the most impactful medical breakthroughs. We look forward to collaborating with industry partners and the FDA to improve clinical trials. Together, we can lead the movement towards more inclusive, effective, and equitable clinical research. The latest guidance: https://lnkd.in/gAbQV4Ek #ClinicalTrials #DiversityInResearch #EquitableTrials #Leapcure #FDA #PatientCentricity #HealthcareInnovation

Top 10 Clinical Trial Trends for 2024! The world of clinical trials is evolving at an unprecedented pace. Here are the top 10 trends shaping the landscape in 2024: #clinicaltrials #clinicaltrials #top10 #fda

In this report, we dive into some of the key trends impacting the #clinical trials industry for 2024. https://lnkd.in/g7WDbDU6

⚡️NEW Blog | Rescue Studies⚡️ Have a study that's facing unexpected roadblocks? Clinical trials are vital for medical advancements, but even the most meticulously planned studies can steer off course. From resource shortages and recruitment issues to adverse events and early analysis indications that it may not demonstrate required drug efficacy - these challenges can bring even the most carefully planned trials to a grinding halt ⏱️ But there's hope! These challenges don’t have to signify the end of the road, a rescue study if executed promptly to address a trials specific needs can be the intervention required to ensure your research is resilient against unexpected setbacks moving forward, to get your study back on track and set up for success. Click below to read our new article and deep dive into rescue studies, the challenges, the additional regulatory hurdles, and how to plan to ensure efficient execution 👇 https://hubs.li/Q02pvYnL0 #ClinicalTrials #Research #RescueStudy #Healthcare #RescueStudiesinClinicalTrials #BiometricCRO

🔔 Exciting Update from the FDA! 🔔 We are proud to support and champion the FDA's latest draft guidance on Diversity Action Plans in clinical trials. At Medovation Clinical Research, we believe that inclusivity is essential for innovation in healthcare. 🌟 Why is this important? The new FDA draft guidance outlines crucial steps to ensure diverse participation in clinical trials, enabling better representation of all communities in the development of groundbreaking treatments and therapies. This is a significant step forward in making healthcare advancements accessible to everyone, regardless of their background. Our Commitment to Diversity: Partnering with Community-Based Physicians: We work closely with community-based physicians who understand and serve diverse patient populations. Enhancing Access:  Our efforts are focused on bridging gaps and ensuring that ALL patients have the opportunity to participate in clinical research, gaining access to novel treatments. Supporting Sponsors and CROs: We bring together community-based healthcare providers and Sponsors/CROs to foster a collaborative environment for inclusive research. Together with our partners, we are dedicated to creating a more inclusive and equitable future in clinical research. 📢 Learn more about the FDA's new draft guidelines here. #DiversityInResearch #ClinicalTrials #InclusiveHealthcare #MedovationClinicalResearch