Publications
Pre.sentient’s research and regulatory interactions
Review the research, validation evidence, and regulatory engagement behind Pre.sentient’s approach to continuous analysis.
Research & methodology
Examine the evidence.
Each paper sets out the statistics, simulations, and operating characteristics behind the methodology. The method itself is summarized in Statistical Methodology.
White paperPre.sentient: the first real-time trial analysis platformThe statistical framework in full: how rolling analysis preserves type I error, the simulation design behind it, and benchmarking against conventional interim approaches.DownloadFutility paperOptimal Stoppage of Doomed ProcessesA single look has to catch everything in one go, which means its threshold is set where noise is likely to trip it — continuous monitoring does not have this problem. For a canonical 36-month trial, continuous monitoring ends a doomed trial about 20 months early, against 13 for a single look at midpoint.Download
Regulatory engagement materials
Regulatory engagement and feedback
FDAISTAND submission and FDA commentsThe submission, regulatory feedback received to date, and materials describing how sponsors may pursue use within an individual clinical trial through existing regulatory pathways.View FDA feedback
EMAInnovation Task Force meeting on continuous interim analysisWe presented Pre.sentient's platform to experts of the EMA Innovation Task Force. The experts saw benefits in principle and raised no concerns for automated futility assessment. As we anticipated, for stopping early for likely success the experts noted that frequent interim testing for efficacy raises type I error considerations. We will proceed to Qualification Opinion via Qualification of Novel Methodologies pathway.
These materials describe engagement and feedback to date. They do not constitute approval, endorsement, qualification, or acceptance of continuous interim analysis by any regulatory agency.