Navigation Links
Cancer biorepository speeds clinical trials, drug development, Moffitt analysis shows
Date:5/7/2013

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 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."


'/>"/>

Contact: Kim Polacek
kim.polacek@moffitt.org
813-745-7408
H. Lee Moffitt Cancer Center & Research Institute
Source:Eurekalert

Related medicine news :

1. Study Suggests Vaccine May Help Kids With Brain Cancer
2. New Stool Test Might Aid in Early Detection of Colon Cancer
3. Study reveals how cancer drug causes diabetic-like state
4. How a cancer drug leads to diabetes
5. You Survived Cancer: Now Pay Attention to Your Overall Health
6. New drug prevents spread of human prostate cancer cells
7. Eliminating the good cholesterol receptor may fight breast cancer
8. Taller, Heavier Women May Face Higher Ovarian Cancer Risk
9. Experimental Chemo Combo for Colon Cancer Disappoints
10. Veggies Like Broccoli, Cabbage May Help Fight Breast Cancer: Study
11. Targeted therapeutics for colon cancer to be presented at AACR meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media ... Pro X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice ... X users can now reveal the media of their split screens with growing ...
(Date:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/27/2016)... ... 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best Buy ... in the United States and Canada wear eyeglasses. Once considered to be a purely ... make a fashion statement. Even celebrities use glasses as a way of creating an ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/26/2016)... Cary, North Carolina (PRWEB) , ... June 26, 2016 , ... ... the release of a new product that was developed to enhance the health of ... harvested for centuries. , The two main herbs in the PawPaws Cat Kidney ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
Breaking Medicine Technology: