Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Cancer Biorepository Speeds Clinical Trials, Drug Development, Moffitt Analysis Shows

08.05.2013
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.”

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 | EurekAlert!
Further information:
http://www.moffitt.org

More articles from Studies and Analyses:

nachricht Researchers simplify tiny structures' construction drip by drip
12.11.2018 | Princeton University, Engineering School

nachricht Mandibular movement monitoring may help improve oral sleep apnea devices
06.11.2018 | Elsevier

All articles from Studies and Analyses >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: UNH scientists help provide first-ever views of elusive energy explosion

Researchers at the University of New Hampshire have captured a difficult-to-view singular event involving "magnetic reconnection"--the process by which sparse particles and energy around Earth collide producing a quick but mighty explosion--in the Earth's magnetotail, the magnetic environment that trails behind the planet.

Magnetic reconnection has remained a bit of a mystery to scientists. They know it exists and have documented the effects that the energy explosions can...

Im Focus: A Chip with Blood Vessels

Biochips have been developed at TU Wien (Vienna), on which tissue can be produced and examined. This allows supplying the tissue with different substances in a very controlled way.

Cultivating human cells in the Petri dish is not a big challenge today. Producing artificial tissue, however, permeated by fine blood vessels, is a much more...

Im Focus: A Leap Into Quantum Technology

Faster and secure data communication: This is the goal of a new joint project involving physicists from the University of Würzburg. The German Federal Ministry of Education and Research funds the project with 14.8 million euro.

In our digital world data security and secure communication are becoming more and more important. Quantum communication is a promising approach to achieve...

Im Focus: Research icebreaker Polarstern begins the Antarctic season

What does it look like below the ice shelf of the calved massive iceberg A68?

On Saturday, 10 November 2018, the research icebreaker Polarstern will leave its homeport of Bremerhaven, bound for Cape Town, South Africa.

Im Focus: Penn engineers develop ultrathin, ultralight 'nanocardboard'

When choosing materials to make something, trade-offs need to be made between a host of properties, such as thickness, stiffness and weight. Depending on the application in question, finding just the right balance is the difference between success and failure

Now, a team of Penn Engineers has demonstrated a new material they call "nanocardboard," an ultrathin equivalent of corrugated paper cardboard. A square...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Optical Coherence Tomography: German-Japanese Research Alliance hosted Medical Imaging Conference

19.11.2018 | Event News

“3rd Conference on Laser Polishing – LaP 2018” Attracts International Experts and Users

09.11.2018 | Event News

On the brain’s ability to find the right direction

06.11.2018 | Event News

 
Latest News

New materials: Growing polymer pelts

19.11.2018 | Materials Sciences

Earthquake researchers finalists for supercomputing prize

19.11.2018 | Information Technology

Controlling organ growth with light

19.11.2018 | Life Sciences

VideoLinks
Science & Research
Overview of more VideoLinks >>>