Digital Twins can increase study power by decreasing variability, and even power secondary endpoints and exploratory analyses.
Accelerating trial timelines
Adding Digital Twins to a clinical trial means fewer patients who receive the placebo, and lower failure rates.
Enabling patient level insights
Digital Twins provide additional evidence to understand the treatment effect: how each patient responded to an experimental therapy in a trial.
First, we prepare a highly curated dataset, so our machine learning model can learn from the relationships. Control arm records from several trials focused on a specific disease are curated to become machine learning ready.
Creating a Curated Dataset
Once the dataset is prepared, we separate it into two groups, one for training, and the other for testing. The machine learning model builds an internal network of connections. We then evaluate the model to ensure it is ready to begin generating Digital Twins.
DiGenesis™: Generating our Machine Learning Model
What is a Digital Twin?
A comprehensive, longitudinal, and computationally generated clinical record that describes what would have happened if a specific patient had received a placebo.
While a patient’s journey in a clinical trial takes months, or even years, a Digital Twin’s record is created after the first visit. Our model uses baseline data to create a complete record that predicts how the patient would have responded if she had not received the experimental treatment.
Creating a Digital Twin
An Intelligent Control Arm is an external control arm populated with Digital Twins. Incorporating an ICA into a clinical trial increases power, provides patient level results when estimating the treatment effect, and can reduce the number of subjects who receive a placebo.
Introduction to Intelligent Control Arms
Use Intelligent Control Arms to augment randomized control trials
With an Intelligent Control Arm, in the design phase, you can decrease the sample size of a trial, reducing the number of patients who receive a placebo. Intelligent Control Arms can be added at any point during an RCT to increase the probability of success while maintaining study randomization and blinding. Even after trials have begun, Digital Twins can be added to increase power.
Supplement single arm trials with Digital Twins
In trials without control arms, adding an Intelligent Control Arm can provide unique insights into how patients would have reacted if they had been given a placebo.
Each patient has a Digital Twin, and a single arm trial can now be analyzed with two arms.