A warehouse of patient-donated biological data expedites trial accrual, reduces trial sizes, saves money, and may speed drugs through the drug development pipeline.
This centralized warehouse has been used to identify and select patients for phase II cancer clinical trials. Total Cancer Care© is a comprehensive approach to cancer that was launched at Moffitt Cancer Center in 2005 in Tampa, Florida. Patients at Moffitt and its partner institutions can donate excess tumor tissue and biological samples for research through the Total Cancer Care© protocol. 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.
Few institutions have the necessary infrastructure to systematically collect and maintain biosamples, related molecular analyses, electronic medical records, and other data from their patient populations.
“By taking a systems approach, biomarker and genetic profile information not only enables personalized medicine, but also promotes comparative effectiveness research,” said Benjamin M. Craig, PhD, coauthor of a study evaluating the biorepository’s usefulness to research and drug development. “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.”
This study sought to understand “value of information” as it related to the effectiveness of data warehousing for 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. The study was published in Statistical Methods in Medical Research (2013; doi: 10.1177/0962280213480282).
“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, PhD, also of 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.