Independent Verification and BRAKES-Strata
We have made some significant updates to the BRAKES platform, with two major releases of functionality, BRAKES-Strata and regulatory testing.
Read the postOur CEO, Tom Coates, joined Dr Andree Bates on AI For Pharma Growth to talk about interim analysis, why so few trials use it well, and what it would take to catch futility and success years sooner.
Most clinical trials fail, and a failing trial keeps enrolling patients who cannot benefit while costing money. Yet a substantial share of commercial trials run no interim look at all, and those that do typically check only once, near the halfway point, stopping if the treatment appears futile.
Clinical Leader's chief editor, Dan Schell, has published a piece on our co-founder Dan Nicolau and the observation that led to Presentient.
Leading by 5 goals is significant. So significant in fact that in the entire 163 year old history of the modern game a 5 goal lead has never been overturned in a top flight game. Maybe time for a rule change?
The FDA comments clarify how the FDA anticipates BRAKES being deployed; sponsors seeking to use BRAKES in the context of a specific clinical trial are to engage with the FDA via individual IND submissions.
The FDA comments clarify how the FDA anticipate BRAKES being deployed; sponsors seeking to use BRAKES in the context of a specific clinical trial are to engage with the FDA via individual IND submissions.
The BRAKES platform accelerates decision-making by months to years while eliminating operational bias.
The FDA's momentous shift on the use of Bayesian methods
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See the statistical foundation behind Pre.sentient and how continuous analysis works in practice.