Synthetic and External Controls
Increased use of single arm trials in oncology or rare diseases requires appropriate comparisons to be developed to document the benefits of the new treatment. Deriving such comparisons from real world or historical trial data is not straightforward and requires data source and methods expertise.
What we do
We select the most appropriate data source based on the requirements of the comparison to be performed. We then harness the latest advances in Bayesian dynamic borrowing, propensity score adjustment and epidemiological microsimulation modelling to derive synthetic controls capable of standing up to clinical and regulatory scrutiny.
More streamline clinical development program. Time and cost savings. Rigorous scientific evidence presented to the regulators.