CLINICAL INSIGHTS & STRATEGY

Optimize trial design and capture best responders

NOVADISCOVERY’s in silico clinical trial technology operates as a digital sandbox in which multiple assumptions can be tested ahead of in vitro and in vivo assays to de-risk clinical development decisions. 

At each step of the development process, NOVADISCOVERY enables drug developers to focus time and resources on the best scenarios:

  • Profiling of optimal responders ahead of human trials
  • Identification of companion biomarkers
  • Exploration of the dose-effect relationship

Focus: predict dose-effect relationship of a new heart-rate moderator for angina pectoris attack

The Effect Model served to predict the dose-effect relationship of a heart-rate moderator in the prevention of angina pectoris attack before trials results became available. A mathematical model of angina attack, a submodel replicating the treatment’s mechanism of action and a virtual population of patients based on a thousand individual case records were developed.

RCT Simulation (dose-effect prediction ahead of confirmatory trials)

On top of exploring the dose-effect relationship on angina attacks, a second model predicted the number of prevented acute coronary syndromes (Number of Prevented Events) by the treatment. While the observed ratio of rates of admission to hospital for fatal or non-fatal myocardial infraction in patients with the treatment and patients on placebo was 0.64 after a median follow-up of 19 months, the simulated ratio came out at 0.66.