Pharmaceutical Product Development (PPD) is refining its design capabilities for adaptive clinical trials through a licence agreement with information technology and consulting services company Tessella and Berry Consultants, a statistical consulting group specialising in the Bayesian approach to medical statistics.
The US-based contract research organisation (CRO) can now use the FACTS software developed by Tessella and Berry Consultants to take a “more flexible, intuitive approach” to designing both adaptive and fixed trials, the partners said.
FACTS comprises a suite of programmes with built-in facilities for simulating interim and final patient responses, patient drop-outs and patient accrual in clinical trials.
The software provides a range of options for replicating both simple and complex designs, the partners noted. It will enable PPD to run clinical trial simulations on particular characteristics of competing designs, which will help the CRO deliver both time- and cost-savings to clients.
Adaptive or fixed
The available simulations are particularly useful for adaptive designs, where adjustments can be made to an ongoing study based on a set of pre-specified conditions, but they can also be applied to fixed trial designs.
The three-way agreement follows a collaboration initiated last year by PPD and Berry Consultants on Bayesian design and analysis in clinical research.
“FACTS is a powerful tool that will enhance our ability to deliver flexible, efficient adaptive trial designs for our clients in less time than we could previously,” commented Susan Atkinson, PPD’s senior vice president of global biometrics.
“The simulations generated by this software will help us create richer designs so that our clients can make better informed decisions about their trials.”