Cytel

A patient-centric approach to clinical research can improve patient outcomes. As part of that endeavor, Julia Poritz, PhD, Loraine M., Hoora Moradian, PhD, and Nathalie Horowicz-Mehler, PhD discuss increasing #patient centricity in comparative effectiveness research by including patient-reported outcome #data in indirect treatment comparison analyses. Read the post to learn more: https://hubs.ly/Q03P8lZR0 #pharma #pharmaceutical #pharmaceuticalindustry #biotech #clinicaltrials #realworldevidence #realworlddata #RWD #HTA #oncology #research

🚨 AI in Biometrics: Your Questions, Answered! 🚨 Following the success of our recent webinar on the impact of AI in biometrics, we're keeping the conversation going—with you at the center. Join us for an Open Panel Q&A Office Hours Session, where five of Cytel’s leading experts will be available to answer your questions on how AI is transforming biometrics in clinical trials: - Steve Thacker, Vice President FSP - Sheree King, Associate Director, Clinical Database Development - Kunal Sanghavi, Associate Director Statistical Programming Management - Juan Pablo Garcia Martinez, Principal Biostatistician - Manuel Cossio, Director Innovation and Strategic Consulting 💡 Whether you're curious about how we’re applying AI to enhance data quality and efficiency, or concerned about the risks and limitations—this is your chance to ask anything. 📅 Reserve your spot now and submit your question during registration to make sure it’s on the list! Register here: https://hubs.ly/Q03P3Fb90 #AI #Biometrics #ClinicalTrials

With the rise of targeted and immunotherapies, we have seen a shift away from finding a drug’s maximum tolerated dose in Phase II dose-finding studies and toward identifying the optimal biological dose. A new method, PKBOIN-12, extends the BOIN12 framework to refine dose finding and final OBD selection by integrating pharmacokinetic parameters. Kevin Trimm discusses PKBOIN-12, the FDA’s Project Optimus, and Cytel’s new East Horizon™ dose-finding module. Read the post to learn more: https://hubs.ly/Q03NSsBr0 #FDA #regulatoryaffairs #software

Going to OCT Nordics next week? Make sure to catch up with Jonathan Burr, Maria Fernström and Ulrika Andersson and discover how we are empowering life science leaders to realize the full potential of their therapies! Book your meeting here: https://lnkd.in/eic65R6k #OCTNordics #ClinicalTrials

In the fast-evolving healthcare ecosystem, demonstrating comparative effectiveness is not just a regulatory checkbox, it is a critical commercial differentiator. Prescribers, payers, health technology assessment (HTA) bodies, and even regulators now seek evidence that a therapy outperforms existing standards of care in routine practice, with the number of HTA dossiers including real-world evidence (RWE) increasing from 6% in 2011 to nearly 40% in 2021. In crowded therapeutic areas, comparative effectiveness has evolved into a core differentiator. Sponsors deploy comparative RWE not just for regulatory compliance, but to: Justify premium pricing and value based contracts. Broaden access across underrepresented populations. Differentiate in saturated markets with evidence-based narratives. Support label expansion via pragmatic real-world data (RWD). Additionally, HTA re-assessments increasingly incorporate real-world outcomes to confirm initial therapeutic value, especially when new comparators enter the market or treatment guidelines are updated. Companies that invest in robust RWE infrastructure and analytic rigor are using comparative effectiveness studies to shape payer perceptions, support HEOR narratives, and extend brand lifecycle. Download our most recent white paper by Marco Ghiani here: https://hubs.ly/Q03NGh830

Cytel is excited to be joining the COG Bay Area Conference in San Francisco on October 21-22. Make sure to drop by booth 21 and meet our team to discover how we are empowering life science leaders to realize the full potential of their therapies. While you're there, make sure to attend Walter Boyle's presentation "Moving From Data Driven to Data Integrated: How to Create Lasting Impact in a Rapidly Changing World" on October 21! Book your meeting here: https://hubs.ly/Q03NqX5r0 #COG #COGBayArea #ClinicalTrials

In healthcare, one of the most pressing challenges lies in rare disease research, but gathering sufficient data to power robust clinical studies or predictive models is a monumental hurdle. Manuel Cossio and Jonas Häggström discuss an emerging solution: the intersection of generative AI and real-world data. With the ability to synthesize patient data that preserves real-world complexity, we can begin to generate insights, hypotheses, and interventions that were once out of reach. Read the post to learn more: https://hubs.ly/Q03N0Wyk0 #AI #artificialintelligence #data #rarediseases

Cytel invites you to an interactive Office Hours session with Nelia Padilla, James Matcham and Mike Fossler, where you can ask anything about various of FDA’s oncology-related guidances. From Project Optimus to Project Frontrunner, or even their latest guidances on Overall Survival and Radiotherapeutics, this is your chance to engage directly with experts and gain insights into how these initiatives are reshaping oncology trial design and regulatory strategy. Whether you’re planning a new study or refining an existing one, bring your questions and leave with actionable answers that can help you navigate the evolving regulatory landscape. Register here: https://hubs.ly/Q03NgzXD0 Note: If you already have a question about any of these regulations, feel free to add it when registering; that way, we'll certainly put it at the top of our list! #FrontRunner #Optimus #FDA

Master protocol trials represent a transformative shift in clinical research — enabling the simultaneous evaluation of multiple therapies or disease subtypes under a unified framework. Hélène Cauwel and Veena P. discuss challenges and best practices as well as the benefit of these innovative designs in oncology trials. Read the post to learn more: https://hubs.ly/Q03N37nx0 #oncology #masterprotocols #clinicaltrials

Analyzing endpoints in multiple sclerosis clinical trials can present several statistical challenges. Anita Chudecka and Ralf Koelbach define common endpoints in MS trials and discuss key statistical modeling techniques to analyze them, as well as how to overcome several statistical challenges encountered in this indication. Read the full article: https://hubs.ly/Q03MTMz90 #multiplesclerosis #MS #statistics #clinicaltrials