leapcure’s Post

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

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.

I was reviewing the latest FDA draft guidance on "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies" and found some key points in section 5C (V. C) worth sharing: - Reducing participant burden by utilizing sites for procedures that are convenient to specific populations included in enrollment goals. - Improving access to clinical studies by selecting study locations that facilitate enrollment of a representative population. If you are looking to work with more Community Sites that are located within representative communities Inato's Site Marketplace can help. Today, over 4,300 Site across the world use Inato to bring the right trial opportunities to their patients. #communitysites #diversity #clinicaltrials For more details, check out the full guidance here: https://lnkd.in/egkvC8F4

Last month, the FDA released its Draft Guidance on "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." The guidance highlights the need for diversity metrics in clinical trials, an important step towards ensuring all populations benefit from medical advancements. Key recommendations for sponsors include simplifying patient participation, selecting sites that support representative enrollment, and decentralizing trials when appropriate. At Science 37, we support these efforts and offer our Virtual Site and Patient Recruitment solutions to help sponsors and CROs achieve their diversity goals. To learn more about our services, visit our website: https://lnkd.in/e6DFnYfi #clinicalresearch #clinicaltrials #clinicalstudies

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 

Bridging the gap between clinical trials and real-world patient experiences is crucial for advancing healthcare. Explore the evolving role of real-world evidence in drug development with insights from Rebecca Miksad, MD, MMS, MPH.

Compact leader Rosa M. Colon-Kolacko, PhD. MBA, CDM, SHRM-SCP joined MassBio’s Patient Advocacy Summit for a conversation on health equity in drug development alongside Nubia Whitaker, MBA, Dr. Ann-Marie Richard and Rohita Sharma, PhD.   In the biopharma industry, decisions and priorities that directly impact health outcomes are made based on data, and that data needs to be representative of and responsive to the communities it serves. All of them.   Even as people of color face unique and disproportionate health issues, they are also vastly underrepresented in the clinical trials that ultimately lead to breakthrough treatments. When we center diverse patient voices, experiences and needs throughout the entire drug development process, we advance health equity through lifesaving and culturally responsive treatments.   As Rosa said, we must look to the communities we serve to define what equitable research experiences look like for them.   Read the full blog from MassBio’s Kendalle Burlin O'Connell, Esq. https://lnkd.in/eY-eRwVq

In this report, we dive into some of the key trends impacting the #clinical trials industry for 2024. https://lnkd.in/e7GZXzDN