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𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥 𝐃𝐞𝐬𝐢𝐠𝐧 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐒𝐩𝐨𝐭𝐥𝐢𝐠𝐡𝐭   Outsourcing-Pharma recently interviewed Samuel Salvaggio, PhD, to discuss how One2Treat is transforming clinical trials with a groundbreaking patient-focused approach. By integrating multiple patient-relevant outcomes into a single primary endpoint, One2Treat can significantly reduce trial sample sizes.   💡 Key Takeaways:   • Patient-Focused Design: Engaging patients already from the trial design phase ensures a meaningful evaluation of efficacy, safety, and quality of life. • Data Utilization: Leveraging more detailed patient data results in greater clinical relevance and minimizes the need for larger sample sizes. • Regulatory Support: Regulatory bodies are increasingly backing innovative methodologies that utilize patient-reported outcomes in clinical trial frameworks.   Discover how One2Treat is setting new standards in clinical research! 🔗 Read the full article here: https://lnkd.in/ezD5N9nv #PDFF #ClinicalTrials #patientfocused

In the fast-paced world of clinical trials, every moment counts. At Miami Clinical Research, we're experts in reducing trial timelines without compromising data quality. Our latest blog explores our innovative approaches to optimizing clinical trials, from enhanced participant engagement to sophisticated data algorithms. Ready to revolutionize your research? Read more here: https://lnkd.in/ghde3cUH #medicalresearch #clinicaltrials #medicalstudies #miamiclinicalresearch #drugdevelopment #clinicalresearch #clinicaltrialmanagement #pharmaceuticalresearch #healthcareinnovation

Outsourcing-Pharma interviewed Samuel Salvaggio, PhD about how One2Treat is paving the way for 𝗺𝗼𝗿𝗲 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝗮𝗻𝗱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁-𝗳𝗼𝗰𝘂𝘀𝗲𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 by incorporating patient relevant outcomes into primary endpoints.    This innovative approach not only accelerates the development of new therapies but also ensures higher precision and more clinically relevant results for patients.   💡 Key Highlights of the Interview: • Involving patients from the design phase ensures a 𝗵𝗼𝗹𝗶𝘀𝘁𝗶𝗰 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗼𝗳 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆, 𝘀𝗮𝗳𝗲𝘁𝘆, 𝗮𝗻𝗱 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 𝗼𝗳 𝗹𝗶𝗳𝗲. • Leveraging more data (i.e. for each single patient) 𝗶𝗻𝗰𝗿𝗲𝗮𝘀𝗲𝘀 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗿𝗲𝗹𝗲𝘃𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗿𝗲𝗱𝘂𝗰𝗲𝘀 𝘀𝗮𝗺𝗽𝗹𝗲 𝘀𝗶𝘇𝗲𝘀. • Regulatory authorities are promoting innovative methodologies that 𝗹𝗲𝘃𝗲𝗿𝗮𝗴𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁-𝗿𝗲𝗽𝗼𝗿𝘁𝗲𝗱 𝗼𝘂𝘁𝗰𝗼𝗺𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲𝗶𝗿 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲.   Discover how One2Treat is driving advancements in clinical trial design 👉 Read the full article here: https://lnkd.in/dBP4w-FZ

Speed up clinical trials with #syntheticdata 🚀

📣 Calling all Clinical Data Scientists and those working on Clinical Trials - JMP 18 has lots of updates for you. Check them out here 👇 #ClinicalTrialSafety #ClinicalTrials

Adaptive trial designs accelerate treatment development, but certain designs are more useful depending on the stage of clinical development, something which IQVIA’s biostatisticians advise our customers on. Our blog looks at some common adaptive design types and their uses. https://bit.ly/3J1Gkri #clinicaltrials #adaptivetrials #clinicaldevelopment

Designing and running a clinical trial involves making many decisions that are unique to the needs of that trial. Central to robust trial design is an effective randomization strategy, but traditional methods aren’t always the best fit. Sometimes what’s best for the trial requires some outside-of-the-box thinking. Join Zelta by Merative and Solventum for an insightful discussion on the importance of randomization in clinical trials and how an innovative approach focused on the enrolling of teeth successfully reduced selection bias. This session will explore the unique challenges faced in clinical trial randomization, Solventum’s story of reducing bias by randomizing participant’s teeth, and how a flexible EDC platform like Zelta can help enable novel solutions like these to meet the unique needs of clinical trials. 👉 Explore the benefits of using a flexible platform for internal research studies and traditional clinical trials 👉Discover how Zelta helped enable Solventum’s strategy of randomizing teeth and how this led to reduced selection bias 🗣Jennifer Duff - General Manager, Zelta Clinical Trial Solutions 🗣Krista Dahling - Supervisor Clinical Data Management 📅 17th October 2024 ⌚ 11am New York / 4pm London 👉 Click here to register for free - https://lnkd.in/dmgyZXwd   #clinicaltrials #EDC #clinicaldata #randomization #clinicaltrialdesign #clinicalresearch #pharma

📰 Today in PharmaTimes Media Ltd, our Founder and President Gen Li, PhD, MBA discusses the new age of #ClinicalTrials. With nearly a third of phase II trials terminated in 2023, Gen highlights that sponsors must adopt a data-driven approach to improve success rates. 📈 Gen explains how Digital Patient Profiles and Digital Trial Arms help to reduce operational costs, improve patient-centricity, and get life-saving therapies to those who need them faster. 💊 👀 Check out the full article, here. https://lnkd.in/ebPG2P77

If you are analyzing clinical trial safety and/or efficacy data, take a look at what's new in JMP Clinical 18: https://lnkd.in/emdPC7V3

Navigating the Latest Trends in Clinical Trials: What You Need to Know In the dynamic landscape of clinical research, staying updated on the latest market trends is essential for success. Recent insights from market research reports highlight several key developments shaping the future of clinical trials. 1. 🌐 Decentralized Clinical Trials (DCTs): DCTs are becoming the norm, offering flexibility and a patient-centric approach. The FDA’s guidelines emphasize technology's role in ensuring patient safety and data integrity, paving the way for broader adoption. 2. 📊 Emphasis on Real-World Evidence (RWE): The shift towards RWE is gaining momentum, with the FDA encouraging the use of real-world data to support regulatory decisions. This trend reshapes trial design, aiming to generate evidence that reflects real-world patient populations. 3. 🌍 Rising Importance of Patient Diversity: Focusing on patient diversity ensures trial outcomes are applicable across various populations. The FDA's guidance stresses the need for inclusive trial designs that consider diverse demographics and subgroups. 4. 🧬 Innovation in Biomarker-Driven Studies: Biomarker-driven studies are advancing personalized medicine by identifying patient subgroups likely to benefit from specific treatments. The FDA’s guidance supports effective implementation of these approaches. 5. 🔄 Adaptive Trial Designs: Adaptive trial designs allow modifications based on interim data, enhancing trial efficiency while maintaining scientific validity. This approach aligns with FDA’s guidance on adaptive designs. Staying informed about these trends and adhering to regulatory standards is crucial for successful clinical trials. By incorporating these practices, we can ensure our research remains innovative, patient-focused, and aligned with the latest industry developments. #ClinicalResearch #MarketInsights #DecentralizedTrials #RealWorldEvidence #PatientDiversity #Biomarkers #AdaptiveTrialDesigns #IbSEcosystem #IbSMarketInsights Reference: U.S. Food and Drug Administration. Clinical Trials Guidance Documents. Retrieved from FDA.gov