Tessella’s Adaptive Trials Simulation Toolkit’ takes Best of Show at Bio-IT World 2007
Last night it was announced that Tessella’s ‘Adaptive Trials Simulation Toolkit’ had been awarded ‘Best of Show’ in the eClinical Technology catagory, at the prestigious Bio-IT World Conference and Expo in Boston MA. The toolkit has been designed to better equip the pharmaceutical community to carry out adaptive clinical trials.
Adaptive clinical trials are a ground-breaking progression, which attempt to increase the efficiency of clinical trials by breaking out of the confines of conventional experimental design.
Tom Parke, Head of Clinical Trial Solutions at Tessella, added: “This award highlights the increased interest in adaptive clinical trials. Developing new ways to run clinical trials is at the cutting edge of optimizing the drug development process; a process that is otherwise sinking into the sand with both increasing costs and a decreasing success rate. To implement adaptive designs requires new statistical frameworks, logistical and organizational support and regulatory approval but the benefits are huge.“
Grant Stephen, CEO of Tessella Inc, commented: “We are delighted that the toolkit has been recognized as a beacon of excellence in the field. Tessella has built up an enviable expertise in adaptive clinical trials technology by working collaboratively with industry leaders. We understand the implications of introducing this new approach so we’re committed to making the transition as simple and stress-free as possible for everyone concerned. This toolkit is an important step in supporting that goal.”
The ‘Adaptive Trials Simulation Toolkit’ contains a range of adaptive clinical trial models for simulating different adaptive methods from phase 1 through to phase 3. The first release includes a Bayesian model for phase 2 trials called ‘NDLM dose finder’, and a ‘Seamless Phase 2/3 Simulator’.
The ‘NDLM dose finder’, developed in collaboration with Berry Consultants, simulates trials run using a Bayesian Model that is updated with response data as the trial runs. A Normal Dynamic Linear Model (NDLM) is fitted to the response data and used to estimate whether any dose will fit the target criteria and which dose it is most likely to be. This allows the model to recommend whether to continue the trial and which doses to favor in randomization. This model is typically more efficient than fixed allocation designs in determining whether there is a dose response and at choosing the right dose range for the next phase.
Tessella’s ‘Seamless Phase 2/3 Simulator’ simulates trials analyzed using statistical techniques developed at the Medical University of Vienna. At the interim analysis between the two phases, the treatment arms to be retained are selected and the sample size for the next phase calculated. The model allows for the multiple treatment arms by controlling the familywise error rate using the closed testing procedure. In addition, the model uses a combination function to combine data from two phases in the final analysis. As well as saving time between phase 2 and phase 3 this approach allows for a smaller phase 3.
Since 1998, Tessella has been helping to drive innovation in drug development by enabling the deployment of adaptive clinical trials. In collaboration with leading statisticians, Tessella has implemented statistical models for phase 1 trials, phase 2 dose finding studies using Bayesian statistics, and phase 2/3 seamless designs. Tessella has supported these models by developing simulation and analysis tools, and by building and running the infrastructure to run the trials. Such infrastructure has included central randomization, electronic data capture, and drug supply management. Tessella has also provided consultancy to pharmaceutical companies to help them adopt adaptive clinical trials and to enhance their own in-house systems so that they can support adaptive clinical trials.
Kevin Gell, Managing Director of Tessella Support Services plc, added: “Tessella’s focus is on helping pharmaceutical clients understand the broader implications of what adaptive clinical trials mean for their specific organizations and how to implement successful adaptive clinical trials strategies. Tessella has been a leading independent supplier of software solutions to the pharmaceutical and biotech communities for many years, priding ourselves on understanding our clients’ business and technical requirements, and working with them to provide innovative, cost-effective solutions.”
Tessella contact details:
