Tom Parke Unveils Prototype Version Of Combination Finder Trial Design Software At CHI's Combination Therapies Conference
Recently, Tessella, the information technology and consulting services company selected by R&D, science and engineering leaders for business-critical assignments previewed clinical trial design software that addresses the challenge of designing Phase 1 trials for combination therapies. Tom Parke, head of clinical technologies at Tessella, presented the prototype version at CHI's combination therapies conference in Philadelphia, PA.
The development of combination therapies is becoming increasingly common in oncology, but currently development teams are limited to traditional Phase I clinical trial designs that only allow them to evaluate changing the dose of one of the agents, keeping the dose of the other agent fixed. This is incredibly limiting, significantly reducing the combination options that are explored, quite possibly missing combinations that offer greater therapeutic value for no increase in the level of toxicity. For a combination of two drugs there will be a series of combined doses which generate the same level of toxicity. What the "Combination Finder" trial design allows the drug developer to do is find the full range of combinations that could be taken forward to further trials.
"A clinical trial seeking to determine the Maximum Tolerated Dose must use as few patients as possible, avoiding either wasting subjects on too-low combinations or too-high toxicity combinations – these would not only be poor for the patients in the trial, but also not as informative from the drug development program as placing subjects on combinations just below the limit of tolerability." said Parke. "Designing these kinds of trials is particularly challenging, and basing our tool on some published work at MD Anderson, University of Texas and the University of North Carolina we believe our prototype will allow the industry to assess how close we are to having a practical solution."
Tessella plan to work with existing users of Tessella & Berry Consultants FACTS clinical trial design software, as well other leading pharmaceutical companies to refine the functionality of the prototype. If successful the capability could be integrated into the next release of FACTS scheduled for September.
About Tessella
For decades, Tessella has been successfully delivering IT and consulting services to world leaders in R&D, science and engineering. Through the application of scientific methods and rigorous quality procedures, we enable clients in life sciences, energy, the public sector, and consumer industries to achieve a wide range of objectives, including, forecasting floods, developing fusion power, enhancing military sensor capability, improving drug discovery and development efficiency, and reducing risk to health and the environment in the extraction and production of oil and gas. With offices in Europe and North America, global companies rely on Tessella for business critical assignments.
For more information, visit www.tessella.com
SOURCE: Tessella