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Applied Clinical Trials and Pharmaceutical Executive Feature Rho Regulatory Experts’ Article: The EU Regulations Catching US Pharma Companies Off Guard
Rho’s Anna Pinsky, MD, PhD, Medical Director, and Elina Smirnova, Associate Director of Start Up Services Europe are featured in Applied Clinical Trials as they take a deep dive into the European regulatory landscape and share their insights on how US Sponsors can keep their European clinical trials on schedule and within budget.
How do we get both information to rule out harm and assess the overall survival benefit, while still being realistic in our conduct of oncology clinical trials? The answer to that question, depends on a variety of factors, such as the type and aggressiveness of the cancer. As you are designing your next clinical trial assessing OS, we have listed some items to keep in mind.
Overall survival (OS) is an endpoint of significant importance when assessing safety and efficacy in oncology studies. Multiple trial design decisions are made when planning the analysis of OS and analysis of OS is even more complicated when it is analyzed as a non-primary endpoint. Here are some common trial design elements to consider that may have potential pitfalls for your next study.
When analyzing overall survival in a post-hoc manner sponsors need to carefully consider the types of analyses to present and have a thorough understanding of both the regulatory precedent and market landscape which their product will enter.
Overall survival (OS) is both an important efficacy & safety endpoint for oncology trials. Often when study results are submitted for regulatory consideration, OS results are often “immature”/still in their early stages which makes them difficult to evaluate. Understanding how to place these results into a proper benefit-risk framework for consideration is therefore important when assessing a potential treatment’s viability.
Rho has once again been chosen as a winner of Triangle Business Journal’s 2023 Best Places to Work Awards. This is the 11th year Rho has been recognized for the Triangle Business Journal’s award “a prestigious award that honors companies for creating policies and a work environment that employees value.”
One of the most rewarding aspects of this recognition is that it is driven by employee surveys, which are then tabulated and ranked by Quantum Workplace. Rho is honored and proud to receive high marks in areas such as team effectiveness, trust with co-workers, manager effectiveness and work engagements from our employees.
If you were born during the Spanish flu of 1918, you had a 2-3x higher risk of Parkinson’s. If COVID-19 caused the same viral damage, what does that mean for all of us? In this webinar, study author Pete Schmidt, PhD (Rho) and Mark Stacy, MD (MUSC Health) discuss the new study and what biopharma sponsors should know about its implications for future movement disorder research.