Publications by authors named "Gustavo A Jimenez-Maggiora"
Background: Investigators conducting clinical trials have an ethical, scientific, and regulatory obligation to protect the safety of trial participants. Traditionally, safety monitoring includes manual review and coding of adverse event data by expert clinicians.
Objectives: Our study explores the use of natural language processing (NLP) and artificial intelligence (AI) methods to streamline and standardize clinician coding of adverse event data in Alzheimer's disease (AD) clinical trials.
Slowing the progression of Alzheimer disease (AD) might be the greatest unmet medical need of our time. Although one AD therapeutic has received a controversial accelerated approval from the FDA, more effective and accessible therapies are urgently needed. Consensus is growing that for meaningful disease modification in AD, therapeutic intervention must be initiated at very early (preclinical or prodromal) stages of the disease.
View Article and Find Full Text PDFObjective: The Alzheimer's Therapeutic Research Institute (ATRI) developed a novel clinical data management system, the ATRI electronic data capture system (ATRI EDC), to address the complex regulatory, operational, and data requirements that arise in the conduct of multicenter Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRDs) clinical trials. We describe the system, its utility, and the broader implications for the field of clinical trials and clinical research informatics.
Materials And Methods: The ATRI EDC system was developed, tested, and validated using community-based agile software development methods and cloud-native single-page application design principles.