Conventional interim analyses are highly inefficient at finding the actual moment in a clinical trial where failure is inescapable or success conclusive. This costs the pharma industry $15bn+ in waste and delays. Presentient solves this with its breakthrough BRAKES platform, which runs 20+ automated interim analyses while eliminating operational bias.
The core constraint is well established and rarely questioned, analysing efficacy data currently requires unblinding, but humans handling unblinded results introduces operational bias and risks trial integrity. This forces sponsors into an impossible choice: remain ignorant of trial progress, or compromise trial integrity. The consequence is that 63% of Phase 2 and Phase 3 trials conduct no interim analysis at all. Trials run to full completion even when failure could have been predicted months or years earlier, with trial patients continuing to receive ineffective treatments, and millions in resources remaining locked in futile trials.
BRAKES eliminates this trade-off. All unblinded analyses occur within a dedicated hardware enclave where an automated algorithm processes data that remains entirely inaccessible to human personnel. A novel Bayesian framework continuously evaluates the predicted probability of trial futility, generating non-binding stop recommendations at the earliest reliable point.
This means BRAKES can help trials to stop months to years earlier than currently feasible, reducing unnecessary patient exposure to ineffective treatments and freeing resources for more promising therapies.
To access the full whitepaper, please complete the form below or contact us on info@presentient.com.