Jeffrey Blum
EastHORN Clinical Services, USA
Title: Use of investigative sites in Central & Eastern Europe (CEE) for successful clinical studies
Biography
Biography: Jeffrey Blum
Abstract
Subject recruitment and retention in clinical studies are identified as major barriers to finishing clinical studies in a timely manner. Soaring drug development costs mean that each day a drug is delayed from reaching the market, sponsors are losing as much as $8M per day. Sponsors must find ways to save time in order to extend drug exclusivity. Using investigative sites in CEE for phase 1b to phase 4 clinical studies can ensure that studies are completed on time or ahead of time. Many sponsors are hesitant to use sites in CEE because they do not understand how to get predictable results, or because they have biases against anything outside of the US or Western Europe. This is known as the “streetlight effect.” As a result, less than 2% of all clinical studies take place in CEE. The goal of my presentation is to take out the mystery of conducting studies in CEE. I will describe the healthcare system, centralized medicine, which funnels patients into relatively few sites and encourages patient retention. I will explain why patients in CEE are eager to participate in clinical studies. I will explain why physicians are motivated to be the top enrolling sites. I will cover why the data from these sites is higher quality than data from other geographies. Finally, I will explain that while study-startup times are somewhat longer, they are predictable (unlike other geographies).