Researchers at Moffitt Cancer Center say identifying and selecting participants for phase II cancer clinical trials from a centralized warehouse of patient-donated biological data expedites participant accrual, reduces trial size, saves money, and may speed test drugs through the drug development pipeline.
Their study, which analyzed datasets from recent clinical trials conducted at Moffitt, was published online March 15 in Statistical Methods in Medical Research.
Launched at Moffitt in 2005, Total Cancer Care is a comprehensive approach to cancer that enables physicians, researchers and caregivers to identify and meet all the needs of a patient and their family during the patient's lifetime and for future generations. At the heart of this approach is the Total Cancer Care Protocol, which allows patients at Moffitt and its partner institutions to donate excess tumor tissue and biological samples for research. The samples are analyzed for biomarkers and other unique qualities and stored in a biorepository for study. Researchers can also use the information to quickly identify potential candidates for clinical trials based on a patient's biological and molecular profiles.
Total Cancer Care enables evidence-based cancer care and helps usher in an era of personalized medicine, a concept the National Institutes of Health has invested in heavily. The authors also note that the National Cancer Institute has funded efforts to develop information and biospecimen infrastructure projects.
Efforts to discover biomarkers for disease and the identification of genetic signatures that can guide treatment selection are driving efforts to create patient biorepositiories. And the future of molecular-based, personalized medicine will uncover new innovations, adding to the body of information available for designing clinical trials, the authors said.
Unlike Moffitt, few institutions have established the infrastructure necessary f
|Contact: Kim Polacek|
H. Lee Moffitt Cancer Center & Research Institute