Sneha Dave’s Post

The FDA recently released draft guidance on Diversity Action Plans, a monumental step towards inclusivity in clinical research! The draft guidance outlines the requirements for sponsors to submit Diversity Action Plans, aiming to increase the enrollment of underrepresented groups in clinical trials. This initiative emphasizes the importance of including diverse populations to improve the generalizability and effectiveness of clinical study results. Key Highlights: 🔹 Detailed goals for enrollment disaggregated by race, ethnicity, sex, and age group. 🔹 Rationale for these goals based on disease prevalence and potential differential responses. 🔹 Comprehensive strategies to achieve these enrollment goals, including community engagement and culturally competent practices. At PEP!IN, we are already prepared to help sponsors navigate these new requirements. Our services are designed to ensure compliance while enhancing patient engagement and retention through: - Culturally competent outreach and support. - Patient matching and recruitment services. - Continuous monitoring and reporting to meet FDA guidelines. - Community Outreach Programs. - Patient Education and Awareness Campaigns. - Cultural Competency Training for clinical staff. - Patient Support Services, including logistical support like transportation and flexible scheduling. - Partnerships with Community Organizations to improve outreach and trust. Let’s work together to make clinical trials more inclusive and effective for everyone. Discover how PEP!IN can support your Diversity Action Plan and engagement initiatives by scheduling a consultation today by visiting www.WeArePEPIN.com or emailing us at contact@wearepepin.com. #ClinicalTrials #DiversityInResearch #FDAUpdates #InclusiveScience #PEPIN

Engaging patients early on in clinical research is key to ensuring that trials are designed with real-world needs in mind. By involving patients from the discovery phase, you can create a foundation of trust, shared goals, and meaningful outcomes. Here’s how to work with patients during this crucial stage: ✨𝗘𝘀𝘁𝗮𝗯𝗹𝗶𝘀𝗵𝗶𝗻𝗴 𝗥𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽𝘀 The first step to meaningful engagement is building authentic relationships with patients. Take time to listen to their experiences and concerns, fostering trust and creating a sense of partnership. By establishing these connections early, you ensure that patients feel valued and heard throughout the trial process. ✨𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗶𝗻𝗴 𝗮 𝗖𝗼𝗺𝗺𝗼𝗻 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗵𝗶𝗽 𝗩𝗶𝘀𝗶𝗼𝗻 We believe patients should have a say in shaping the vision of the research. Co-create a shared understanding of what success looks like and how the trial can meet the needs of both researchers and participants. This collaborative approach ensures that patient perspectives are integrated into the very fabric of the trial. ✨𝗜𝗱𝗲𝗻𝘁𝗶𝗳𝘆𝗶𝗻𝗴 𝗞𝗲𝘆 𝗜𝘀𝘀𝘂𝗲𝘀 Through open dialogue, work with patients to identify the issues that matter most to them. Whether it's understanding potential barriers to participation or addressing specific health concerns, focus on what will make the trial more relevant and accessible. ✨𝗣𝗿𝗶𝗼𝗿𝗶𝘁𝗶𝘇𝗶𝗻𝗴 𝗧𝗼𝗽𝗶𝗰𝘀 Patients can help you prioritize which topics and challenges to tackle first. By involving them in this process, you ensure that the trial focuses on addressing real-world challenges that will have the most impact on outcomes. ✨𝗙𝗿𝗮𝗺𝗶𝗻𝗴 𝘁𝗵𝗲 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻 Patients can play a crucial role in shaping the foundation of your trial. By considering patient input when framing the question, you ensure that the research addresses their most pressing concerns, leading to more meaningful and applicable results. #PatientEngagement #ClinicalResearch #PatientCentricity #InclusiveResearch #ResearchWithPatients #HealthEquity

Diversity in Clinical Trials: More Than Just a Buzzword. Achieving diversity in clinical trials isn't an easy feat, but it's essential. Eventhough this is outside of my area of expertise, championing diversity and inclusivity in the medical industry is something I am personally passionate about. A recent study dives deep into the barriers that impede diverse participation and the monumental importance of overcoming these obstacles. The study, conducted through qualitative interviews with professionals and patient/public representatives, highlights a crucial gap in our approach to medical research. With a focus on early-phase clinical trials, it underscores the disparities that can no longer be ignored. Why does this matter? For one, diverse clinical trial participation ensures that medical treatments are effective across the board, catering to a broad spectrum of genetic backgrounds and lifestyle factors. The lack of diversity not only hampers the accuracy of results but also perpetuates healthcare inequalities—something we, as a part of the healthcare community, have a duty to rectify. Here's a link to the study: [https://lnkd.in/eY9FU8Ph) Your thoughts? Check this out: https://lnkd.in/e8-Ka4Yi

Time to STEP UP: methods and findings from the development of guidance to help researchers design inclusive clinical trials https://lnkd.in/diHsfdbU It is important to design clinical trials to include all those who may benefit from the intervention being tested. Several frameworks have been developed to help researchers think about the barriers to inclusi...

Discussions in the industry are progressing from ‘why’ to ‘how’ to ‘now’ when involving patients in clinical research design. Our experts have identified some key themes that emerged from both the US and European Patients as Partners in Clinical Research conferences, that took place in March and May respectively. Some of these trends and themes include: - More consistent and earlier approach to patient focused drug development (PFDD) - Equitable access to research including health literacy and diversity, equity and inclusion - Measuring impact of patient engagement in research - Improving the sponsor, site and study participant partnership - Participant data release in clinical trials - Compensation for study participants Read the full report to access our key themes and reflections at https://buff.ly/3XPY7uj #PatientsasPartners #ClinicalResearch #PFDD #patientengagement #medcomms #healthliteracy #patients

Discussions in the industry are progressing from ‘why’ to ‘how’ to ‘now’ when involving patients in clinical research design. Our experts have identified some key themes that emerged from both the US and European Patients as Partners in Clinical Research conferences, that took place in March and May respectively. Some of these trends and themes include: - More consistent and earlier approach to patient focused drug development (PFDD) - Equitable access to research including health literacy and diversity, equity and inclusion - Measuring impact of patient engagement in research - Improving the sponsor, site and study participant partnership - Participant data release in clinical trials - Compensation for study participants Read the full report to access our key themes and reflections at https://buff.ly/3L7pBnH #PatientsasPartners #ClinicalResearch #PFDD #patientengagement #medcomms #healthliteracy #patients

Do you know What a Clinical Trial is? The Body's Battlefield: Exploring the World of Clinical Trials A new treatment, a revolutionary therapy, holds the potential to change lives, offering hope and healing for millions. But before this revolutionary treatment can reach your loved ones, your neighbors, or even yourself, it has to navigate a crucial battlefield—the world of clinical trials. Are you ready to explore more about this fascinating world? Whether you're just starting out or looking to deepen your knowledge, dive into the world of Clinical Trials in our new blog article. #ClinicalResearch #clinicaltrials #drugdevelopment https://lnkd.in/eGX3wfCs

I've never enjoyed my job more than I do right now - it's such an exciting time in medicines development! In this report, we summarise our key takeaways of where we believe we are now and where we hope to go in patient engagement.

Democratizing Clinical Trials: A Rallying Call for Change On May 8, 2024, the prestigious Milken Institute Global Conference brought together healthcare leaders to discuss a crucial issue: expanding diversity in clinical trials. As Silas Buchanan, CEO of OurHealthyCommunity, took the stage, Michelle McMurry-Heath, CEO of Biotechquity Clinical, looked on, eager to engage in this pivotal dialogue. Despite recent awareness, women and people of color remain underrepresented in clinical studies, hindering the pursuit of truly representative and equitable healthcare solutions. The work of bringing diversity to research is complex, but these leaders, including Raven Clinical, are determined to pave the way forward. One of the resounding messages was the need to build trust within communities that have faced mistreatment or exploitation by the scientific community. Fabian Sandoval, President and CEO of the Emerson Clinical Research Institute, emphasized the importance of breaking down barriers and fostering genuine connections. "It's for us physicians to take off our lab coats, take off the bow tie, and talk normally to people," he said, underscoring the value of investing time to develop direct relationships with patients. This call to action resonated throughout the panel, as experts acknowledged the scarcity of time in healthcare but recognized its pivotal role in achieving meaningful progress. Doctors and researchers working on clinical trials must be willing to dedicate the necessary time to build trust and engage with diverse communities truly. At Raven Clinical, we are at the forefront of this movement, fostering collaborative partnerships and leveraging cutting-edge technology to ensure equitable and ethical research practices. Our focus is on conducting innovative trials that accurately reflect the diverse populations we serve. As healthcare leaders continue to plot strategies for expanding diversity in clinical trials, one thing is clear: success will hinge on our collective ability to understand and address the unique needs, perspectives, and concerns of underrepresented populations. Only through open dialogue, empathy, and a genuine commitment to inclusivity can we unlock the full potential of medical breakthroughs that benefit all. Join Raven Clinical and the broader movement to democratize clinical trials and ensure that healthcare innovation represents and serves every individual, regardless of background or circumstance. #ClinicalTrialDiversity #HealthcareEquity #MilkenInstitute #RavenClinical

What are clinical trials? Why would someone take part in one? Come along to this free webinar! Clinical Trials Explained 24 May 2024 https://lnkd.in/gQmJnrA8