On July 14th 2008, at the 3rd Trial Design Innovation Conference in Washington DC, Tessella will launch its ‘Adaptive Trials Simulator’: a significant tool designed to help statisticians and managers in the area of designing and supporting Adaptive Clinical Trials.

Adaptive clinical trials increase the efficiency of clinical trials by allowing the trial to adapt to the data being gathered as the trial runs, allowing more effective use to be made of the subjects treated in the trial, and enabling better informed and quicker decisions to be made about the drug being developed.

Grant Stephen, CEO of Tessella Inc, stressed: “Running clinical trials is the most expensive and time-consuming and challenging phase of drug development, but at the same time their rigor and integrity are paramount for our health and safety.”

Tom Parke, Head of Clinical Trials Solutions at Tessella, added: “Developing better ways to run clinical trials is critical to improving the drug development process; a process that is suffering from increasing costs and a decreasing success rate. In the past insufficient attention has been paid to how the best treatment regime is selected prior to phase 3, and adaptive designs offer a huge opportunity to improve this stage of the process.”

The ‘Adaptive Trials Simulator’ is built around a flexible core design for phase 2 dose finding studies developed by Berry Consultants. The design includes options for a longitudinal model and a dose response model. The longitudinal model is used to predict patients’ final outcomes from their early responses and increases the information available early on in the trial, the dose response model is used to estimate the dose response across the range of doses being tested. The resulting Bayesian probability model is then used to estimate the probability that each dose conforms to the user’s selected target criteria for the trial (e.g. to find ED90 or a Minimum Efficacious Dose). These probabilities can be used to recommend terminating the trial (e.g. when there is sufficient certainty that the desired target dose has been located, or when there is sufficient certainty that no dose is sufficiently effective) or if the trial is to continue, which doses to favor when allocating the next patients.

Both adapting the allocation towards the dose most likely to meet the target criteria and modeling the dose response, increases the accuracy of the final estimate of the dose response of the drug compared to conventional designs. Whilst continuously monitoring the termination criteria allows failing trials to be stopped early, preventing subjects being needlessly exposed to ineffective treatments and saving the sponsor company considerable wasted expenditure.

The release of the ‘Adaptive Trials Simulator’ with Dose Finding capabilities is the first of many new functions, products and services that Berry Consultants and Tessella are developing to provide pharmaceutical companies and biotechs options for improving their drug development process.

Since 1998, Tessella has been helping to drive innovation in drug development by enabling the deployment of adaptive clinical trials. Tessella has supported these developments 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 a significant track record of helping companies run adaptive trials, working successfully with a number of pharmaceutical companies and partnering with a number of CROs. 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.”

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Notes to editors:

For press enquiries or to arrange an interview with Tessella please contact Alison Smith, Marketing Manager on +44 (0) 1235 555511 or alison.smith@tessella.com

• Founded in 1980, Tessella specializes in the application of innovative solutions to scientific, technical and engineering problems, and its offices within the UK, US and the Netherlands have built long-term relationships with organizations at the leading edge of the scientific and engineering world. Tessella is vendor independent and recommends ‘best of breed’ solutions, whether this involves custom software development or off-the-shelf solutions
• Tessella services include software design & development, mathematical modeling & simulation, algorithm development, infrastructure support, project management and consultancy. The company’s enviable reputation for providing high-quality, low-risk, value for money services is backed up by many successful, high-profile projects, plus a high level of repeat business
• Tessella’s life sciences expertise and experience spans: Adaptive Clinical Trials Management & Simulation, Drug Supply Forecasting, Informatics & Knowledge Exploitation, ‘Omics Data Management & Analysis, Laboratory Automation & Workflows, Biomarkers & Systems Biology, PK/PD Modeling, Toxicity Modeling, Drug Formulation & Delivery Modelling
• Berry Consultants is a statistical consulting company specializing in adaptive clinical trial design in pharmaceutical and medical device research and development. They are leaders in the Bayesian approach to statistics – which is radically changing the way research is done throughout the medical industry. They employ world-renowned experts in Bayesian statistics and strive to set the standard for Bayesian design and analysis in the statistical and medical communities.
• Trial Design Innovation: In 2008 the Trial Design Innovation conference promises to once again live up to its reputation as a leading event on adaptive trials, by delivering new case study examples from a fresh speaking faculty of senior-level executives from pharma, biotech and device companies sharing their experiences, both positive & negative, early & late-phase, when designing, implementing and executing adaptive trials
• Tessella will be demonstrating its capabilities in adaptive clinical trials at the 3rd Annual Trial Design Innovation Conference
• Additionally, Tom Parke, Head of Clinical Trials Solutions at Tessella, will be presenting “Utilizing trial design simulation processes to optimize clinical supply before and during the trial” at the conference

Tessella contact details:
For more information, please visit our website www.tessella.com or email
info@tessella.com

Tessella Inc
233 Needham Street, Suite 300
Newton, MA 02464
USA

Tel: (1) 617 454 1220, Fax: (1) 617 454 1001

Tessella Inc also has an office in Washington DC

Tessella Support Services plc (Group Headquarters)
3 Vineyard Chambers
Abingdon
Oxfordshire, OX14 3PX
UK

Tel: +44 (0) 1235 555511, Fax: +44 (0) 1235 553301

Tessella also has UK offices in Burton upon Trent, Cambridge, Stevenage, Warrington and Winchester

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