A major challenge in drug development clinical trials is the proper handling of variability and uncertainty. Without a proper statistical approach, drug development risks including more patients than necessary, resulting in excessive costs and resource requirements, or, worse, risks including too few patients, resulting in failed trials. Currently available solutions to handle variability and uncertainty are either nonexistent, inefficient, or not readily accessible. Efficient, publicly available, targeted, and regulatory-grade quantitative solutions are needed to address these specific unmet needs in drug development for various disease areas.
The work of the Quantitative Medicine (QuantMed) Program at Critical Path Institute (C-Path) focuses on the development of advanced, regulatory grade, data analysis (quantitative) solutions to accelerate development. Successes include the transformation of drug development paradigms in areas including (but not limited to) Parkinson’s Alzheimer’s type 1 diabetes, tuberculosis, and a wide array of rare diseases. QuantMed leverages knowledge from a network of experts in industry, academia, nonprofit and regulatory sciences combined with integrated data from multiple sources to develop actionable solutions that combine clinical pharmacology, statistics, mechanistic modeling, artificial intelligence, pharmacometrics and digital health technology (or remote health technology) data.
The solutions developed by QuantMed are often formally reviewed by regulatory agencies and endorsed for specific applications in drug development. Because QuantMed’s philosophy is one of open science, solutions developed are publicly available as open-source platforms. The QuantMed Program is highly collaborative and advances the development of novel treatments for patients with unmet medical needs.