Structural Biology

Biography

Biography: Jose Luis Pio Cruz Lopez

Abstract

In the past two decades we have seen that clinical trial methods, technologies and recruitment have not changed too much. We have been witnessing of how pharmaceuticals, CROs, international regulatory entities and IT have moved from working alone to collaboration. Sentinel System (FDA’s national electronic system) has transformed the way researchers monitor the safety of FDA-regulated medical products. The personalized medicine is evolving and approaches better to patient’s health and specified therapies for the best outcome. Evolution of clinical trials moves to be faster and a more responsive model will allow to speed up the process of scientific validation with support of artificial intelligence can be helpful in every phase. Innovative approaches to patient recruitment using artificial intelligence and information exchange between patient medical information and clinical trials helps to meet the best options for patient’s treatment. Clinical trials will be moving from the traditional method to an adaptive trial designs using risk-based monitoring that will allow pre-identification rules for trial conduct error, data visualization for pattern and missing data analysis, centralization and streamlining of data collection, site performance diagnostics and determination of the probability of risk factors. It will be required to have a quick process for scientific validation and regulatory agency reviews so patients can have new and safe treatments available at the market.