Our Client's Challenge:
Our client came to us with no available data on the dose-response relationship of a bronchodilator on pre-school children aged 2.5 to 6 years. They wanted us to estimate the dose-response and the Minimum Tolerated Dose.
The Cytel Solution:
First Cytel tested 5 doses of the drug in question. It seemed like many statistical models adequately captured the data. Therefore, Cytel employed MCPMod methods to determine which statistical models fit the data best.
By using MCPMod methods, Cytel was able to combine proof-of-concept and dose-resposne modeling into one clinical trial. The new resulting model also predicted what the dose-response would be in dose-sizes not yet tested. This provided viable hypotheses for new dose-arms, and enabled the trial to move into Phase 3 confident that it had selected the correct dose.
Click to read more about MCPMod Methods and the only validated software that performs these cutting-edge analyses