DoseSim and tcVisualize with Monte Carlo combine to enable cost-effective response adaptive clinical trials

Cambridge 16 July 2007Cytel Inc. and Tourtellotte Solutions have integrated Cytel's DoseSim adaptive trial simulator and Tourtellotte's tcVisualize clinical trial supply chain simulator with Monte Carlo computational methods. The joined products provide accurate simulation of the clinical supply and randomization necessary for response-adaptive clinical trials, ensuring more predictable, cost-effective adaptive trials.

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Cytel is a provider of statistical services and software for the design and conduct of clinical trials. Tourtellotte is an expert in off-the-shelf and custom supply chain software for the pharmaceutical, retail, and consumer goods industries. The two companies introduced and demonstrated a prototype of their integrated applications at the ExL Pharma Trial Design Innovation Conference in Arlington, Virginia.

Response-adaptive trials can reduce development lead times and costs and boost clinical trial success rates, and are therefore of intense interest to biopharmaceuticals. Yet, the difficulties of performing response-adaptive randomization and the drug supply uncertainties inherent in adaptive trial designs are daunting to many. The Cytel-Tourtellotte simulation package resolves both problems, opening the way to wider adoption of response-adaptive trials.

"The risk of drug stock-outs and supply overage in adaptive trials is highly significant", stated Ranganath Nayak, Chief Executive Officer of Cytel Inc. "The uncertainties have caused some companies to abandon the idea of conducting response adaptive trials, or, at least, to drag their feet. Our integrated solution minimizes the risk of both stock-outs and overages for an optimal response-adaptive supply system. This will really open up the value of flexible, adaptive trials."

Ed Tourtellotte, Tourtellotte Solutions' CEO, concurred, adding: "The advanced supply modelling and visualization capabilities of our software combination make it significantly easier to plan complex, multi-site studies. And thorough planning is the key to successful adaptive trials."

The dose-adaptive trial simulator package, the second integration announced this year by Cytel Inc. and Tourtellotte Solutions, aids trial design and enables supply system rebalancing as the actual trial progresses. Cytel's DoseSim, the trial design and randomization component of the integrated solution, offers planners the choice of either advanced Bayesian or Frequentist based statistical models to optimize the design of dose-finding and dose-selection trials. It maximizes the likelihood of choosing the right dose for confirmatory Phase 3 trials, thereby improving Phase 3 success rates.

"This is a good way for sponsors to improve the ROI on clinical development of drugs and devices", stated Ranganath Nayak. Tourtellotte's tcVisualize, the supply simulation component, is a desktop-based visual simulator and forecaster that allows a supply team to run and compare unlimited supply scenarios with varying parameters including Monte Carlo analysis and variable dosing capabilities.

Celebrating its 20th anniversary, Cytel Inc. is a provider of clinical trial consulting services, specialized statistical software, and outsourced clinical study reports for the biopharmaceutical, medical device, academic, and research institute markets. Cytel's validated trial designs reduce development lead time and costs while increasing the probability of clinical trial success. Cytel Inc. is headquartered in Cambridge, Massachusetts, with software development and outsourcing facilities in Philadelphia, Pennsylvania and Pune, India.

Tourtellotte Solutions is a global expert in off-the-shelf and custom supply-chain software for the pharmaceutical, retail, and consumer goods markets. Tourtellotte Solutions' tcVisualize, a groundbreaking clinical supply chain modelling and forecasting application for the pharmaceutical industry, is used by several of the largest pharmaceuticals. Tourtellotte also sells RockBlocks, widely used for managing sourcing in the retail, consumer goods industries. Tourtellotte Solutions is a privately-held company headquartered in Wayland, Massachusetts.


Leslie Versweyveld

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