Joanna Klopotowska’s Post

📢 Decision-making in weaning adult cardiogenic shock patients from VA #ECMO?? Clinical decision making regarding #ECLS liberation challenging and requires a well-structured weaning approach: to improve and harmonize this complex decision process, here a novel type of survey embedded into a clinical discrete choice modeling experiment. Participate to improve insights into the process of weighing multiple factors in complex weaning decisions. 🖋️ Join this 20-minute survey, approved by EuroELSO Steering Committee. 🔗 https://lnkd.in/d_Ba2ihf

The star of the show isT.J. Sharpe and the reality of why we are still having this exhaustive conversation... is because of courageous humans like you and bewildered humans like me! Thank you so very much for changing my focus when I heard you speak for the first time almost 9 years ago. There is simply no more appropriate perspective than the lived human clinical trial participant and healthcare human experience in demonstrating the WHY NOT!! Informed decision making requires a commitment to ensuring the timely sharing of linked health data generated by patients/study participants wherever they are on their care journey and helps all stakeholders understand the patient experience, the evolution of patient safety, product effectiveness over time and valuable evidence generation. Solutions to ensure a risk-based, meaningful, pro-active, ethical approaches/options for the return of individual participant data and lay summaries demonstrates reciprocity, respect and partnership, requires global harmonization and flexibility and has the ability to transform the cultural thinking about what is possible when we critically think and re-think about our shared mutual objectives, reducing burden on health systems and patients to accelerate medicines development. Essential to ensuring the sustainability of R&D and improving global health equity. Providing pragmatic personalized options which matter most to patients and their care providers and securing mechanisms that will facilitate the convergence of clinical care and clinical research is no longer an option. #DIA2024 Session #373 Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) Innovative Health Initiative (IHI) Facilitate Project TransCelerate BioPharma Inc. Society for Clinical Research Sites (SCRS) CISCRP #pfdd #CRACO #Collaborating with #patients to enable a healthier future for all. Enabling #innovation and #equity ambitions through co-creation and global collaboration. #datasharing #patientsaspartners #healthinformation #bioethics

📢 The protocol of the multicenter, retrospective, observational study RECLAIM, is now available on: https://lnkd.in/eWyXXZHW The RECLAIM study is part of the EU-funded research project "Clinical impact through AI-assisted MS Care" (CLAIMS) and is one of two clinical studies in this project.   ▪ The main objective of RECLAIM is to collect retrospective data from more than 11,000 people with MS, CIS, RIS, NMOSD and MOGAD to create a unified database integrating both real-life clinical information and data from clinical trials for the construction of AI-based models.   ▪ RECLAIM aims to develop MRI-based tools to better monitor disease progression of people with MS , as well as AI-based models to predict disease progression and response to treatment, including: (i) a biomarker-based model of MS progression, (ii) an MRI-based generative model to predict the evolution of brain features, and (iii) a model for treatment optimization. #CLAIMS #RECLAIM #CLINICALTRIAL

🚀 Dig deeper into the world of precision medicine with our upcoming webinar! Join us on April 25th, 2024, for expert discussions on "3 strategies for RWD challenges in clinical research and trials." In this session, industry leaders Eric McDavid, RWD & Technology at Lifebit and Philip Awadalla, PhD, National Scientific Director at Canadian Partnership for Tomorrow's Health | Le partenariat canadien pour la santé de demain , will investigate the critical role of real-world data (RWD) in advancing precision medicine by discussing the current challenges around using RWD and showcasing solutions to enable the use of population level data and diverse studies for R&D. 🧑💻 Uncover actionable strategies for leveraging RWD effectively in clinical research and trials. Secure your spot now: https://bit.ly/3UgIIQc #PrecisionMedicine #RealWorldData #RWD #ClinicalResearch #ClinicalTrials #LifebitWebinars #Lifebit

After numerous discussions with clients about their #Asthma and #COPD clinical trials at the European Respiratory Society Congress, I have decided to share this info with a broader audience and start a post series on the 6 biggest challenges in the respiratory disease clinical research. Number one major challenge is the disparity between the recruitment targets and the actual number of patients enrolled. Delays in subject recruitment can disrupt study timelines and inflate costs. Some sites, despite best efforts, find it difficult to reach the targeted numbers. This leads to extended recruitment periods, increased expenses, and delayed study completion. Contributing factors include continued access to specific phenotype populations, difficult inclusion and exclusion criteria, and low engagement of patients. hVIVO employs data-driven recruitment strategies to provide realistic patient recruitment projections, ensuring that studies meet their targets on time without overpromising. By utilizing FluCamp recruitment arm, the database of around 80.000 subjects with #respiratorydiseases and latest technology solutions, we can navigate through the list of highly engaged patient population, ready to be enrolled in #clinicaltrials. Stay tuned for more! #hvo

Listen to a recent KoNECT webinar where our early phase experts discussed strategic approaches for first-in-human (FIH) studies and early clinical development. During this session we explored best practices in cohort planning and dose selection in first-in-human (FIH) studies, options for running a hAME study, progression into early patient studies, and the use of pharmacometric analyses using data from FIH studies to facilitate informed decision making. https://ow.ly/Pey750TKz1e?

Our commitment remains steady this year, as we continue to dismantle barriers hindering patient access to #precisionmedicine. In our latest collaborative qualitative study, "𝑺𝒕𝒂𝒌𝒆𝒉𝒐𝒍𝒅𝒆𝒓𝒔' 𝒆𝒙𝒑𝒆𝒄𝒕𝒂𝒕𝒊𝒐𝒏𝒔 𝒐𝒇 𝒑𝒓𝒆𝒄𝒊𝒔𝒊𝒐𝒏 𝒎𝒆𝒅𝒊𝒄𝒊𝒏𝒆: 𝑨 𝒒𝒖𝒂𝒍𝒊𝒕𝒂𝒕𝒊𝒗𝒆 𝒔𝒕𝒖𝒅𝒚 𝒕𝒐 𝒊𝒅𝒆𝒏𝒕𝒊𝒇𝒚 𝒂𝒓𝒆𝒂𝒔 𝒐𝒇 (𝒎𝒊𝒔)𝒂𝒍𝒊𝒈𝒏𝒎𝒆𝒏𝒕", we aimed to understand and explore different PM stakeholders' expectations. 🎙 We conducted structured interviews with participants from five stakeholder groups: patients/patient advocates, healthcare providers (HCPs), researchers, policymakers/regulators/payers, and industry representatives, and we sought a broad reach across geography, roles, experiences, and disease areas. We found out that the barriers are multifaceted depending on the stage: diagnostics, interpretation of results, clinical trial, and therapy. 👉 Discover in the paper the priorities and suggested actions to overcome the barriers to optimal implementation of PM: https://lnkd.in/dErJn5u9 🙌The wonderful team of authors who have contributed with their expertise and time to this study: Tanya Knott (Sarah Jennifer Knott Foundation), James Creeden, MD PhD, Benjamin M. Horbach (Roche), Zorana Maravic (Digestive Cancers Europe), Maximiliane Rauch, Lidewij Eva Vat and Helena Harnik, MBA (from From Testing to Targeted Treatments (FT3)

Exciting Breakthrough in Pressure Ulcer Treatment! 🌟 We are thrilled to share the results of the R.I.S.E. U.P. Study, a groundbreaking clinical trial evaluating the effectiveness of the EmoLED medical device in treating stage II and III pressure ulcers. This study is the first randomized clinical trial demonstrating the power of Photobiomodulation with Blue Light! ✅ The results? A 76% greater reduction in PUSH scores for patients treated with EmoLED compared to conventional therapy. ✅ 97.2% of patients treated with EmoLED showed significant wound improvement, compared to only 56.1% in the control group https://lnkd.in/gEdUdF3n

Currently attending the World Orphan Drug Congress in Boston, the Alethium team (Joseph Farrell, Brant DeBow and Carissa Sinclair) found Rachael Sawaya's perspective on mobile visits in rare disease research to be particularly noteworthy. 💡 Patient enrollment and retention remain major obstacles in rare disease medical research, and Sawaya illustrated how mobile visits in clinical trials can bridge that gap. ✅ Mobile visits ease the burden on patients and their families to travel, leading to enhanced participation and compliance. ✅ Researchers can engage with participants who may live in remote or underserved areas, broadening their pool of potential participants. ✅ Reaching more participants, researchers can achieve a more diverse study population, which is essential for understanding rare diseases. ✅ In-home visits enable real-time monitoring of participants' health and treatment progress, offering researchers more accurate and timely data for the study. ✅ Remote training for local healthcare providers expands expertise in areas with limited sites. At Alethium Health, our platform integrates mobile visits to streamline trial protocols and enable convenient participant-researcher interactions. By simplifying data collection and monitoring, we help drive progress in rare disease research without logistical complications. 🌐 #ClinicalTrials #WorldOrphanUSA #ClinicalTrialsMobileVisits

In case you missed it, yesterday was a big day in #clinicalreseach with the Draft Guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies AND The White House Clinical Trials Forum. The White House Clinical Trials Forum emphasized that "it takes everyone if we're really going to change...outcomes...WHO participates...and WHAT do we choose to understand". The forum had 2 fireside chats: 🎇 People-centered Clinical Trial Innovation 🎇 Improving Clinical Trial Access and Participation It's a 60-minute forum hearing from White House Office of Science and Technology Policy, FDA, National Institutes of Health, Office of the National Coordinator for Health Information Technology (ONC), Advanced Research Projects Agency for Health (ARPA-H), Citizen Health, Cancer Moonshot. "This is personal to everyone. It's about human beings and our lived experience. A vision where clinical trials develop science that reflects the impacts of therapies on diverse populations, that everyone should have access to trials..., we need to build trials that can easily reach people, we need to build trials that builds bridges between places where innovation happens and community practices so that innovation happens everywhere." https://lnkd.in/gftH_MJW