Tessella, an IT consultancy based in the UK, is partnering with Texas-based Berry Consultants to offer a jointly developed simulator for both fixed and adaptive clinical trials: Tessella Berry FACTS. According to an announcement, the simulator supports adaptive trial design by first providing an assessment of the likely benefit of using an adaptive design. It helps researchers compare design options, including the choice of response model, longitudinal model, and adaptation strategy. It also aids in refining trial design to optimize operating characteristics, and in creation of a simulation report.
The offering "will both reduce the barriers to adoption of adaptive clinical trials and ensure that the technique is used most effectively," says Tom Parke, head of clinical technologies at Tessella, in the announcement. Top among such barriers are those identified recently by Perceptive Informatics: regulatory acceptance concerns, lack of understanding about new techniques, and lack of rapid access to clinical endpoint data.
Berry is a statistical consultancy that advocates the Bayesian inference approach to medical statistics. This approach, in which evidence or observations are used to update a hypothesis, suits adaptive designs.
Tessella has also announced a partnership with CRO Cmed in which the two will ensure interoperability of the Timaeus data acquisition and management system with Tessella FATES, a fixed and adaptive trial execution system. The near real-time reporting capabilities of Timareus are relevant to adaptive trials because they can minimize delay in the availability of response data and therefore adaptation of a trial according to Parke, in an announcement.
- read the Berry announcement
- and check out the Cmed release