Abstracto

Clinical surveillance to monitor and maximize efficacy in primary endpoints in epilepsy trials

Sharon Ceanna Fernando

Epilepsy is a complex disorder, noted for its heterogeneous and unpredictable manifestation which can amplify diagnostic uncertainty. This can be exacerbated by variability in access to diagnostic methods and site personnel experience with various epileptic syndromes. Even when the clinical diagnosis is accurate, seizure frequency is notoriously difficult to measure reliably and even more problematic to assess in pediatric epilepsy trials. These concerns are intensified when trials are performed on a global scale and across numerous study centers that conduct neurological clinical trials in multiple indications. I will discuss how Syneos Health can help minimize the risk of these issues through the use of our Clinical Surveillance and Training (CST) team. In addition, Syneos Health can offer additional value propositions regarding the next stage in clinical development ??? commercialization. Research indicates that 75% of products across various indications that reach the market are commercial failures because they lack integrated planning across the clinical and commerical continuum. At Syneos Health-the industry???s only biopharma accelerator, we understand the worldwide gold standard for solving intricate problems and optimizing opportunities, thereby ensuring that promising compounds have the important support in order to make it to market. Clinical Surveillance & Training has over twenty years of experience working in clinical trials and works to streamline efficiencies to address data impacting errors discovered during seizure diary review processes, thereby helping to increase the likelihood of commercial success in Epilepsy Trials.