If rodent trials were better designed, the cost and time required to develop cancer drugs could be significantly reduced, according to a commentary in the Oct. 28 online issue of the Journal of the National Cancer Institute.
Melinda Hollingshead of the developmental therapeutics program at the National Cancer Institute in Frederick, Md., reviewed the components of a well-designed rodent trial, which is a key step in cancer drug development that must occur before human clinical trials. Mistakes and delays in previous drug development programs have been attributed to poor rodent trials.
According to Hollingshead, the important steps include:
• The identification and use of an appropriate animal model and study endpoints
• Correct statistical evaluation of the data
• Proper randomization
• The inclusion of a sufficient number of animals for statistically meaningful data.
In discussing the consequences of improper experimental design, Hollingshead argues that while properly designed experiments may cost more money or require the use of more animals initially, they ultimately save resources and are necessary to streamline the study.
"The conclusions drawn from a series of studies are only as good as the data on which they are based. The impact of high-quality experimental design, methodology, and data interpretation cannot be overstated," she writes. "Along with a savings in animals, there will likely be a concomitant savings in costs and time, contributing to an overall reduction in drug development costs."
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