"By taking a systems approach, biomarker and genetic profile information not only enables personalized medicine, but also promotes comparative effectiveness research," Craig said. "The contribution of a data warehouse that integrates clinical, biospecimen and molecular data for conducting clinical trials is essential for making good decisions about resource allocation."
By conducting a "value of information" study on the effectiveness of data warehousing in conducting phase II clinical trials, the authors found that patient accrual for trials was quicker when using data from the Moffitt biorepository. They also found that fewer patients needed to be enrolled in a study and that the amount of information recovered was equal to the amount of information gleaned from trials with greater numbers of participants.
"Our study provides evidence that programs, such as the Total Cancer Care Protocol, that follow patients and collect clinical data for storage in a common warehouse can reduce the number of patients needed for a clinical trial without compromising the results of the study," said study lead author David Fenstermacher, Ph.D., chair of the Biomedical Informatics Department at Moffitt. "Another positive impact of using the biorepository for clinical trial participation is that phase II trials that test new cancer treatments being developed by the pharmaceutical industry move more quickly and cost less."
According to the authors, the effective assessment of new molecular-targeted therapies for tumors will be an essential part of stratified clinical trials design as trials become smaller, shorter, cheaper and more individualized. They also suggested that the d
|Contact: Kim Polacek|
H. Lee Moffitt Cancer Center & Research Institute