BRAKES sees everything while eliminating the risk of operational bias.
Legacy of Blinding
Clinical trial interim analyses have not changed much since the 1980s.
This is because clinical trial blinding means key data can rarely or never be looked at by humans which has limited the potential for innovation.
The large majority of industry sponsored blinded Phase 2 & 3 trials stated they did not use an interim analysis.
Our Two Innovations
With BRAKES, Presentient has advanced the state of the art in the field of data science to process unblinded data using automation inside dedicated enclaves to ensure it is blinded to all humans.
Incorporated inside BRAKES, we have developed a novel high performing method optimised for rolling interim analyses which uses a statistical adversarial approach to Bayesian inference.
Halved Trial Duration
BRAKES can run 20+ “looks” per trial. BRAKES run on over a million realistic simulated trials, its prediction algorithm stops over half of failing trials a less than a third of the way in, potentially saving around 50% of the cost.
On realistic datasets BRAKES' error rates can be as low as 0.2% for BRAKES falsely recommending trial stoppage.
The BRAKES Prediction algorithm validated with billions of individual patients in live client trials, historical Patient data and high quality synthetic trials
Trial Diversity
BRAKES' prediction algorithm is applicable to almost all clinical trial types other than some medical device and Phase 1 studies.
For the last 3 years we have validated BRAKES against a range of trial designs and data types from public source datasets with individual patient level data, client data from large and small biopharma companies.
BRAKES outperforms existing methods on almost every dimension.
Granular Detail
BRAKES has been tested against noisy, heterogenous and complex trials. We have also developed our own stochastic simulation toolset for generating realistic synthetic trials that map on to distributions and effect sizes found on clincaltrials.gov.
Security of your data is our top priority.
Presentient is designed to secure your data and built with security embedded into its foundations.
We are accredited for ISO 27001:2022 for our Information Management System, demonstrating secure principles across our design and implementation.
Visit our Trust Centre to learn more about our security processes and controls.