Pharmaceutical & Regulatory

Sciences Workshop

How to improve study design, monitoring and analysis for evaluating drug/device safety via comparative clinical trials

Date & Location: TBD

To evaluate the potential toxicity of a new therapy, regulatory agencies often require a sponsor to conduct a large study before and/or after the approval of the therapy. Generally, such a study is event-driven and the choice of the acceptable safety level may not have meaningful clinical interpretations. As a result, studies may be unnecessarily large and of long duration, thereby delaying drug development and potentially adversely affecting patients’ treatment management. In this workshop, we explore alternative approaches from both the clinical and statistical point of view to deal with the critical issues of designing, monitoring and analyzing safety clinical comparative studies. The goal of the workshop is to discuss approaches to speeding up the drug safety evaluation process to make it more efficient and reliable. In addition to the discussion of these issues, case studies describing recent cardiovascular-related toxicity studies will be presented.