Tessella has run many Phase II response-adaptive trials where frequent, automated adaptation of the randomization schedule, based on data in the trial so far, generates several benefits:
- ability to select more carefully from a larger number of treatment groups
- less patient exposure to ineffective or toxic treatment groups
- more information gathered about most promising treatment groups
- opportunity to stop trial recruitment early either for futility or success
Compared to a traditional design with a fixed trial size, the latter two benefits enable months of time savings in the development process and very significant monetary savings by reducing the total number of patients involved in a Phase II trial. When a single interim is manually convened, this still typically only achieves a fraction of the gain of a smarter, automated approach, because of reduced opportunity to pick up anything other than the strongest signals for futility or success.
Tessella provides a free cost-benefit calculator in the form of the Phase II adaptive trial cost-benefit calculator workbook (Excel format). This is a useful starting point for assessing the costs associated with a trial, and the potential savings for going adaptive. Enter parameters representing your cost model in terms of center costs, per-subject and per-month costs for recruitment, screening, data monitoring and IVRS, and fixed costs. Costs associated with convening manual interims or upgrading your IT infrastructure to permit adaptive randomization are included. Then, based on simulations from Tessella’s FACTS product or other sources, estimate the typical trial lengths in terms of subject numbers in a number of different scenarios such as a marginally successful result. The tool then computes the relative costs of the different designs in these scenarios. It also provides a feature to combine several possible trials to estimate the overall impact on the whole drug development program.
Contact us if you have any questions or comments about the tool, or if you would like to discuss further how Tessella can help in modeling your trial program