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 received Clinical Leader and Life Science Leader’s 2023 CRO Leadership award, marking a long history as an award recipient. Forty-six CROs were evaluated on more that 20 different performance metrics. Respondents evaluated companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that survey responses are based on actual involvement with CROs and clear experiential data.
Rho was recognized for Exceeding Customer Expectations in Compatibility and Quality and received 4 Individual Attribute Awards in Data Quality, Technology for Real Time Access to Data, Therapeutic Expertise and Operational Excellence.
