Pharmaceutical Product Development LLC (PPD) has signed a license agreement to use Tessella and Berry Consultants' FACTS software to create a more flexible, intuitive approach for designing both adaptive and fixed trials. The software expands PPD's adaptive design capabilities by giving biopharmaceutical companies greater ability to use extensive simulations to investigate various study design options. These simulations are particularly useful for adaptive designs, where different options are available for making adjustments to an ongoing trial based on a set of pre-specified conditions, but they also can be used with fixed designs.

The software, developed by Tessella and Berry Consultants, is comprised of a suite of programs that has built-in facilities for simulating interim and final patient responses, patient dropouts and patient accrual. FACTS provides a range of options for replicating both simple and complex designs, and it enables PPD to run clinical trial simulations on certain characteristics of competing designs, enhancing the company's ability to deliver time- and cost-savings for clients.

"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," said Susan Atkinson, Ph.D., 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. This agreement also demonstrates our commitment to enhancing our position as a leader in adaptive trial design among full-service contract research organizations."

Grant Stephen, CEO of Tessella, added, "We are honored that a leading global contract research organization such as PPD is using our FACTS software to expand its adaptive trial design capabilities. FACTS provides a low-risk, end-to-end solution for PPD to employ innovative trial designs that optimize drug development programs for its clients."

This agreement follows a collaboration that PPD entered into with Berry Consultants last year in Bayesian design and analysis, areas of adaptive trial design that have brought significant changes to how clinical research is conducted.

Scott Berry, president and senior statistical scientist at Berry Consultants, noted, "The new functionality and features in FACTS support PPD's goal of continuing to strengthen its adaptive design capabilities. The company's decision to utilize this software is an important step in its efforts to create powerful, efficient designs for its clients, and it reflects the ongoing collaboration we share with PPD."

Adaptive trials incorporate a variety of design approaches to carry out a clinical development program. Adaptive designs use accruing data to change the trial as it proceeds, which offers the opportunity to leverage preliminary data to decide whether to stop a study early or change a design element within the study to increase its chance of success.

Adaptive trial design is a practice area within PPD Consulting, which was established last year to deliver consultative services to address significant regulatory and market challenges.

Date: November 14, 2012
Source: Pharmaceutical Product Development LLC