Critical Path Institute (C-Path)

Watch "Leveraging Learnings for the Future of Drug Development" from #CGIC2024. This session emphasized the importance of insights gained from previous studies to help refine dosing, formulation, and administration methods for pediatric patients.  On demand: https://lnkd.in/gGXfEmsB #CPath #RareDisease #drugdevelopment #datasharing #collaboration  #globalhealth #PEDs

Have questions about some achievements C-Path has accomplished? Whether you’re curious about how we collaborate with stakeholders, or how we’re accelerating the development of new treatments, our FAQs section is a valuable resource designed to give you the insights you need. Have a question we haven’t answered yet? Don’t hesitate to reach out—we’re always here to help and provide guidance. You can find more questions and answers on C-Path's website under FAQS: c-path.org/faqs.  #C-Path #FAQs #DrugDevelopment

Patrice Verpillat, Head of Real-World Evidence, Data Analytics and Methods Task Force at the European Medicines Agency delivers the keynote on day 2 of #CGIC2024. The day then continued with its first panel discussion, from Data to Knowledge.  Data sharing is crucial for drug development, especially for diseases like ALS. Trust, equity, and community engagement are vital for success. Watch the opening remarks here and keynote address: https://lnkd.in/gqR9xUAu #CPath #EMA #Data #RealWorldEvidence

Interested in C-Path updates? Be sure to subscribe at https://lnkd.in/gWQkrvtH For 20 years, C-Path has been providing vital infrastructure to generate a neutral environment for everyone working in drug development to collaborate, not compete. Let's improve lives, together. #CPath #drugdevelopment #neutral #datasharing #globalhealth #collaboration #regulatoryscience

C-Path CEO Klaus Romero recently engaged in a thought-provoking conversation with Patrizia Cavazzoni, Director of FDA’s Center for Drug Evaluation and Research. They explored how CDER-led initiatives are transforming clinical trial processes, striking a balance between modernization and the essential scientific and clinical rigor. Don't miss out on this insightful discussion. Watch it now: https://lnkd.in/gjScdwpU #CPath #InnovationInHealthcare #ClinicalTrialAdvancements #FDA #CDER #HealthcareExcellence #PatientOutcomes

🆕 New manuscript in Springer Nature! 🆕 Investigating item response theory model performance in the context of evaluating clinical outcome assessments in clinical trials. This manuscript is based on a simulation study designed and executed by Cole Ayasse, Ph.D. to assess the appropriateness of two common item response theory models for use with clinical trial data. It should help psychometricians and statisticians know they’re choosing the right model when using IRT to evaluate clinical trial data and for them to better understand the implications of sample size and test length on the model assumptions. IRT models are an increasingly popular method choice for evaluating clinical outcome assessments for use in clinical trials. Given common constraints in clinical trial design, such as limits on sample size and assessment lengths, the current study aimed to examine the appropriateness of commonly used polytomous IRT models, specifically the graded response model and partial credit model, in the context of how they are frequently used for psychometric evaluation of COAs in clinical trials. Read more: https://rdcu.be/d3nOq Cheryl Coon #CPath #Collaborations #GlobalHealth #COA #DrugDevelopment #IRTModels

Did you know that you can now donate to C-Path using the Combined Federal Campaign? Are you a Federal employee or retiree? Then GIVE HAPPY to us through CFC using charity code #28364. One of the great benefits of the CFC is that you can give though payroll deduction or through your retiree annuity, giving a little each pay period and supporting our mission all year long.  #CPath #CFC #Donate #DrugDevelopment 

🆕 New manuscript in Springer Nature 🆕 Conceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints This manuscript unpacks the thought process of interpreting the meaningfulness of treatment effects when considering group-level comparisons. It has already sparked discussions about the methods used in our field for interpreting group-level differences and the stakeholder perspectives that should be considered when doing so. Read more here: https://rdcu.be/dWvhD Cheryl Coon, Cole Ayasse, Ph.D. #CPath #DrugDevelopment #GlobalHealth #Collaboration #COA

Have questions about some areas C-Path has expertise in? Whether you’re curious about how we collaborate with stakeholders, or how we’re accelerating the development of new treatments, our FAQs section is a valuable resource designed to give you the insights you need. Have a question we haven’t answered yet?  Don’t hesitate to reach out—we’re always here to help and provide guidance. You can find more questions and answers on C-Path's website under FAQS: c-path.org/faqs. #C-Path #FAQs #DrugDevelopment

Watch C-Path's Predicative Safety Testing Consortia members, Executive Director Nicholas King and Scientific Director Graham Marsh, moderating a panel on Transforming #TranslationalSciences: From Biomarkers to New Approach Methodologies. Transforming translational sciences from biomarkers to new approach methodologies  is crucial for several reasons. One reason is improved drug development: By utilizing NAMs, researchers can better predict the safety and efficacy of new therapeutics. This approach can lead to more informed decisions during the drug development process, potentially reducing the time and cost associated with bringing new drugs to market. The shift from traditional biomarkers to new approach methodologies is essential for advancing translational science, improving drug development processes, promoting personalized medicine, and addressing ethical concerns in research. Learn more about why NAMs are crucial in drug development: https://lnkd.in/gBemPDgA #CPath #drugdevelopment #datasharing #collaboration #globalhealth #Biomarkers #NAMs