Clinical Trials text mining can speed key decisions, effective site selection and trial design
Clinical trials form the cornerstone of evidence-based medicine, and are essential to establishing the safety and efficacy of new drugs. Each new drug, before being approved by regulatory agencies, must pass through a set of gates. At the very basic level these include phase 1 for first-in-human safety; phase 2 for efficacy and biological activity against the target; and phase 3 for safety, efficacy and effectiveness of the new therapeutic.
At each of these phases, careful planning is essential for a successful study. The clinical study protocol covers objective(s), design, methodology, statistical considerations and organization of a clinical trial, and ensures the safety of the trial subjects and integrity of the data collected.
Over recent years, clinical trial designs and procedures have become more diverse and more complex. The impact of precision medicine means trials have to be more carefully planned to ensure adequate statistical power for smaller patients groups, and adaptive, umbrella, basket and n-of-1 trials are now more frequent.