Operate a smarter trial

Implement adaptive trials easily

Adaptive trials have more complicated implementation requirements than a traditional fixed design.  Any approach based on manually convened interim analyses becomes increasingly fraught as the number of interims is increased – but only by frequent adaptation can adaptive trials reach their full potential in the learning phase.

Tessella believes the best way to run an adaptive trial is to take the software algorithm used to design the trial, and to run the same code during the trial itself in a repeatable, automatic way.  We built an adaptive trial execution environment to do this, and have hosted complex trials for several pharmaceutical clients, large and small, with the algorithms deployed to the Tessella environment.

The Tessella trial execution environment provides

• Flexible validated central randomization capabilities, integrated with statistical algorithms
• Easy integration to your CRO’s EDC and/or IVRS technology
• Automated reporting to authorised unblinded or blinded monitors
• No reliance on statisticians to perform analyses manually during the trial, but opportunity for statistical review at every adaptation
• Full history of adaptation available – shows how the trial evolved and how the adaptive design performed
• Configurable options such as workflow for arm-dropping approval, features for DSMB to deactivate randomization to treatment groups on safety grounds
• Predictive reports for supply chain and to assist timing of DMC meetings

The proven Tessella approach supports adaptive trial execution with known technology and processes, rather than as an exceptional burden on external statisticians.  Treating adaptive trials as the rule rather than an exception reduces your implementation costs.  Learn how Tessella works with CROs

Avoid risk of operational delays to time-critical patient data

EDC systems are frequently ‘heavy’:  they may need several weeks to integrate patient data from an investigators report. Tessella can reduce the risk of operational delay caused by heavy EDC systems by implementing a parallel light weight EDC process to provide  a fast, efficient collection for a key subset of trial data. This approach is particularly important when running an adaptively designed trial, which needs trial data to determine the future operational direction of the trial.  This approach delivers an additional advantage because it acts as a second validation tool to the primary database. Our experience shows that this secondary validation can reduce data error by ~5%.

Minimize waste and avoid stockouts for clinical trials supplies

Supplies for your trial may comprise 5-10% of your trial costs. For example a typical 400 subjects phase 2 trial may cost in the order of $5m, but in some cases such as cancer trials or biologics based trials these costs can even be higher. Establishing a better estimate of the supplies required for a clinical trial enables the reduction of over production and supply (“overage”), which may be as high as 200-400%. Tessella simulates supply scenarios during clinical trial to reduce uncertainty, review alternative supply strategies, and ultimately enable trials to minimize “overage”. We built a supply forecasting tool to perform these simulations. The tool uses sophisticated statistical models to generate realistic and scientifically accurate forecasts of:

• The likelihood of losing subjects due to the lack of supply
• The number of subjects that can be recruited for a given amount of drug
• The amount of drug required to reliably recruit a given number of subjects

This approach is particularly important for the supply of an adaptive trial where supply requirements can vary based on incoming patient data.  More PDF