Cancer biorepository speeds clinical trials, drug development, analysis shows

May 8, 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 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 . 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 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 has funded efforts to develop information and biospecimen .

Efforts to discover biomarkers for disease and the identification of genetic signatures that can guide 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 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."

Explore further: New Moffitt Cancer Center patent promises to accelerate cancer trials

More information: smm.sagepub.com/content/early/ … 80213480282.abstract

Related Stories

New Moffitt Cancer Center patent promises to accelerate cancer trials

February 14, 2012
A new patent has been issued to Moffitt Cancer Center for a computerized system that efficiently selects the right patient for the right clinical trial. The newly patented system matches the registered patient's own molecular ...

Psychoeducational intervention changes patient attitudes on clinical trials participation

June 13, 2012
Seeking ways to change cancer patients' perceptions and negative attitudes towards clinical trials participation, researchers at Moffitt Cancer Center conducted a study offering two different kinds of intervention to two ...

Surgery and radiation improve survival for metastatic gastric cancer patients, study shows

February 27, 2013
Researchers at Moffitt Cancer Center studied patients with metastatic gastric cancer and found that those who have both surgery and radiation have better survival than those who receive one or no form of treatment.

Biological markers increase clinical trial success rate of new breast cancer drugs

October 1, 2012
Using biological markers—genetic characteristics that are associated with some patients with breast cancer—can increase the success rate of clinical trials for breast cancer drugs by almost 50 per cent, says new research ...

New guidance urges improved reporting of important outcomes for patients in trials publications

February 28, 2013
Clinical trials provide us with the best evidence to guide patient treatment and inform health policy. Yet, crucial information, on outcomes reported directly by patients such as their quality of life, is often left out of ...

Recommended for you

Shooting the achilles heel of nervous system cancers

July 20, 2017
Virtually all cancer treatments used today also damage normal cells, causing the toxic side effects associated with cancer treatment. A cooperative research team led by researchers at Dartmouth's Norris Cotton Cancer Center ...

Molecular changes with age in normal breast tissue are linked to cancer-related changes

July 20, 2017
Several known factors are associated with a higher risk of breast cancer including increasing age, being overweight after menopause, alcohol intake, and family history. However, the underlying biologic mechanisms through ...

Immune-cell numbers predict response to combination immunotherapy in melanoma

July 20, 2017
Whether a melanoma patient will better respond to a single immunotherapy drug or two in combination depends on the abundance of certain white blood cells within their tumors, according to a new study conducted by UC San Francisco ...

Discovery could lead to better results for patients undergoing radiation

July 19, 2017
More than half of cancer patients undergo radiotherapy, in which high doses of radiation are aimed at diseased tissue to kill cancer cells. But due to a phenomenon known as radiation-induced bystander effect (RIBE), in which ...

Definitive genomic study reveals alterations driving most medulloblastoma brain tumors

July 19, 2017
The most comprehensive analysis yet of medulloblastoma has identified genomic changes responsible for more than 75 percent of the brain tumors, including two new suspected cancer genes that were found exclusively in the least ...

Novel CRISPR-Cas9 screening enables discovery of new targets to aid cancer immunotherapy

July 19, 2017
A novel screening method developed by a team at Dana-Farber/Boston Children's Cancer and Blood Disorders Center—using CRISPR-Cas9 genome editing technology to test the function of thousands of tumor genes in mice—has ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.