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 for the systematic collection and maintenance of biosamples, related molecular analysis, electronic medical records and other data from their patient populations, said study co-author Benjamin M. Craig, Ph.D., associate member of Moffitt’s Health Outcomes and Behavior Program.
“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 development of new, molecular-targeted treatments will require the use of clinical, molecular and biospecimen data generated from the point of care.
Their analysis of the effectiveness of the Total Cancer Care® Protocol, through which more than 96,000 patients have consented to donate tissue samples and clinical data for biowarehousing and analysis has shown the benefit to those conducting clinical trials and the patients participating.
“The knowledge gained from our study and other studies under way at Moffitt are providing the foundation for creating the next generation of data management infrastructure to support personalized medicine,” Fenstermacher said. “As these resources mature, data assessment strategies, such as ‘value of information’ studies, will be imperative to understand how data can be used to enhance patient care and improve treatment outcomes through evidence-based guidelines.”
The study was funded by National Cancer Institute grants 5K25CA122176 and 5UC2CA148332.
About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Since 1999, Moffitt has been listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, twitter and YouTube.
Media release by Florida Science Communications
Kim Polacek | Source: EurekAlert!
Further information: www.moffitt.org
More articles from Studies and Analyses:
Biorefinery business could put the South Australian forest industry back on the growth track
20.12.2013 | VTT Technical Research Centre of Finland
New study shows that more than half of consumers will choose a health-care plan that costs too much
20.12.2013 | Columbia Business School
Swimming microengines made from platinum and iron are highly efficient in removing organic pollutants from water using hydrogen peroxide.
Researchers from the Max Planck Institute for Intelligent Systems in Stuttgart have developed a new method for the active degradation of organic pollutants in solution by using swimming microengines.
The mobile microcleaners consist of an outer iron and an inner platinum layer, thereby combining two functionalities. Hydrogen peroxide, which must be ...
A 12-year study of massive stars has reaffirmed that our Galaxy has four spiral arms, following years of debate sparked by images taken by NASA's Spitzer Space Telescope that only showed two arms.
The new research, which is published online today [17 December] in the Monthly Notices of the Royal Astronomical Society, is part of the RMS Survey, which was launched by academics at the University of Leeds.
Astronomers cannot see what our Galaxy, which is called the Milky Way, looks like because we ...
In collaboration with the University of Basel, an international team of researchers has observed a strong energy loss caused by frictional effects in the vicinity of charge density waves.
This may have practical significance in the control of nanoscale friction. The results have been published in the scientific journal Nature Materials.
Friction is often seen as an adverse phenomenon that leads to wear and causes energy loss. Conversely, however, too little friction can be a disadvantage as well – ...
A new type of transistor that could make possible fast and low-power computing devices for energy-constrained applications such as smart sensor networks, implantable medical electronics and ultra-mobile computing is feasible, according to Penn State researchers.
Called a near broken-gap tunnel field effect transistor (TFET), the new device uses the quantum mechanical tunneling of electrons through an ultrathin energy barrier to provide high current at low voltage.
Penn State, the National Institute of Standards and Technology and IQE, a specialty wafer manufacturer, jointly presented their findings at ...
The team of Johannes Zuber at the IMP in Vienna, Austria, managed to overcome remaining key limitations of RNA interference (RNAi) - a unique method to specifically shut off genes.
By using an optimized design, the scientists were able to inhibit genes with greatly enhanced efficiency and accuracy. The new method facilitates the search for drug targets and improves the interpretation of experimental results.
The IMP will make this „RNAi toolkit“ available to researchers. Results of the study are published in ...
20.12.2013 | Materials Sciences
20.12.2013 | Life Sciences
20.12.2013 | Life Sciences
19.12.2013 | Event News
11.12.2013 | Event News
10.12.2013 | Event News