Science 37’s Post

In-Depth Analysis of #OncologyClinicalTrials Complexities Challenges, Breakthroughs, Industry Climate, Strategies, and Innovations. The domain of #clinicaltrials serves as a fundamental pillar in the evolution of #medicalscience ( #lifescience ), playing a crucial role in the transition of #noveltherapies and treatments from experimental stages to #clinical application. Within this expansive field, #oncology clinical trials are of paramount importance, focusing on addressing the pervasive and complex #globalhealth burden posed by #cancer . This comprehensive analysis aims to explore the intricate environment of the clinical trial industry, with a keen focus on #oncologytrials, by evaluating their inherent complexities, the multifarious challenges faced, recent advancements, the current industry milieu, and the #strategicinnovations employed to ensure the effectiveness and efficiency of these trials while mitigating potential obstacles. https://lnkd.in/daMPEgXi Critical Path Clinical Solutions

Co-authors Diana Brixner, BPharm, PhD, FAMCP; NOREEN MATTHEWS; Terry Richardson, PharmD, BCACP; Daryl Pritchard, PhD; John Fox, MD, MHA; Scott Ramsey, PhD, MD are pleased to share the accepted poster “Optimizing The Use of Oncology Biomarker Testing Using Health Plan Best Practices and Quality Measures” at #AMCPNexus 2024. To learn more, please visit poster # C23 Poster abstract available in the latest supplement of JMCP (page S21): https://lnkd.in/ezkNUWFZ #precisiononcology #AMCPmarketinsights

👀🎬 A look back on the first edition of #THRPTX. Few days ago, we hosted the inaugural Therapeutics Innovation Summit (THRPTX) at our R&D Institute at Paris-Saclay. This groundbreaking event brought together world-renowned scientists, researchers, and industry leaders to explore the frontiers of medical innovation, with a focus on oncology. 🔎 From AI-driven drug discovery to cutting-edge immunotherapies, the discussions illuminated pathways to transform patient care. Prof. William G. Kaelin, 2019 Nobel Laureate in Medicine, set the tone with his inspiring keynote on cellular adaptation to oxygen availability. 👉 The summit exemplified our commitment to open innovation and collaborative research. By fostering dialogue between diverse stakeholders, we aim to accelerate therapeutic progress and address unmet medical needs. 🙏 We're immensely grateful to all participants for their invaluable contributions. The insights gained will fuel our ongoing efforts to develop innovative solutions for patients facing cancer. Read more 👉 https://swll.to/xDshrVA #WeAreServier #MovedByYou #innovation #health

Your clinical oncology data has untapped potential to help advance patient care and unlock new research opportunities. In this webinar, Q-Centrix's Vice President, Oncology Market Lead Karen Schmidt, ODS, Senior Vice President of Data and Research Victor Wang, and Director of Research Kate Sheeran, MSN, AGPCNP-BC, explore how clinical data intersects with research study data. Transform your registry data from a perceived cost center to an asset with infinite possibilities—by taking this opportunity to see clinical data differently!📲 https://lnkd.in/g-TzGaY5 . #SeeItDifferently #ClinicalResearch #ClinicalDataManagement

And last but not least, Michele Jonsson Funk, Jennifer Lund (UNC Gillings School of Global Public Health, UNC Pharmacoepi, UNC Lineberger Comprehensive Cancer Center) and team begin a new Triangle CERSI project to tackle a well-known challenge with using external #comparatorgroups for #clinicaltrials, particularly in #oncology. An index date is the starting point for measuring outcomes. The timing of when to start tracking outcomes in the comparator group affects the estimated risks and can introduce biases. By using simulations and real-world examples, the research team aims to evaluate different index date selection strategies and their impact on bias and outcome estimation. The findings will inform FDA discussions, support regulatory decisions, and enhance the understanding of external comparator arm designs, particularly in complex settings like #rarediseases and oncology.   This project addresses charge 1 of the FDA’s regulatory science framework: Modernize development and evaluation of FDA-regulated products with a focus on methods to assess #realworlddata to serve as #realworldevidence. The Triangle CERSI is a Center of Excellence funded by the FDA to University of North Carolina at Chapel Hill and Duke University with partners, North Carolina Central University and North Carolina State University. To date, the Triangle CERSI has generated $11.1 million toward accelerating access to emerging scientific approaches essential for the FDA to remain at the forefront of regulatory decision making. 

In just a decade, the number of approved companion diagnostics (CDx) surged from 20 (1998-2012) to 134 (2013-2023), highlighting a significant acceleration in development. 🚀 Despite this progress, the use of CDx and biomarkers in oncology has seen a decline from 52% in 2021 to 28% in 2023, as targeted therapies gain prominence. 📉 Discover the trends and advancements shaping the future of precision medicine. 🌟 Read our latest report for a deep dive into these shifts! 📖🔍 https://lnkd.in/dvRRqxeg #PrecisionMedicine #PersonalizedHealthcare #Genomics #CompanionDiagnostics #TargetedTherapies #AIinHealthcare #CRISPR #Biomarkers #MedicalInnovation #FutureOfMedicine #HealthcareRevolution #PatientCare Vrushabh Waral Janhvi Neema Kamal Namdev

Latin America (LATAM) is poised for a major role in cancer research! This abstract explores the region's potential, highlighting: • Evolving regulatory landscape: Learn how LATAM is streamlining clinical trial processes. • Underrepresented patient population: Discover the impact on drug development. • Fortrea's CRO experience: See how we're helping navigate the LATAM landscape. https://lnkd.in/eCp5A-et #ClinicalTrials #LATAM #CancerResearch

This was an insightful read that emphasizes the crucial role of a data-centric, customizable approach in enhancing the efficiency and effectiveness of clinical trials. Check it out here: https://lnkd.in/gkVMkdmE

If you missed Friday's live session on 'Strategies to Improve Oncology Research,’ led by NCODA Fellow Zara Imtiaz, PharmD, RPh, it is now available on-demand for members. Catch up and deepen your understanding of how oncology research fuels clinical practice advancements, elevating patient outcomes, and explore the role of AI in data analysis and the hurdles interdisciplinary teams encounter when integrating clinical trial information. Get started here: https://bit.ly/3wuZNh6

Navigating Early-Phase Trials in Oncology with Bayesian and Frequentist Designs : This on-demand webinar will equip you with the knowledge to navigate the complexities of early-phase trials. ✔️Gain insights into the key features of bayesian and frequentist designs ✔️Discover how targeted agents and immunotherapy are being investigated through innovative trial designs ✔️Delve into critical statistical caveats such as the early incorporation of randomization, the challenges of sample-size calculation, and the strategic use of biomarkers for more efficient trial outcomes.  https://lnkd.in/e7dJ3DR3  #trialdesign #bayeasiandesign #frequentistdesign #Phase1trials #immunotherapy #clinicalresearch