Sunday, September 21, 2008

Quality Assurance in Clinical Trials

Public release date: 21-Sep-2008

American Society for Therapeutic Radiology and Oncology

Quality assurance programs improve clinical trials

Boston – Quality assurance programs like the one at the Quality Assurance Review Center (QARC) in Worcester, Mass., strengthen the quality of clinical trials, including cooperative groups conducting National Cancer Institute-supported clinical trials, thereby improving the standard of care in cancer patients, according to a study presented September 21, 2008, at the American Society for Therapeutic Radiology and Oncology's 50th Annual Meeting in Boston.

The Quality Assurance Program, provided by QARC at the University of Massachusetts Medical School, was founded in 1980. The program's services include site credentialing to ensure that those looking to conduct clinical trials have the expertise, equipment and tools necessary to properly participate in research trials. The Quality Assurance Program also establishes benchmarks to monitor the ongoing trials and provide feedback to the physicians conducting the trials. This monitoring helps ensure that patients get the best treatments possible while making certain that the data obtained from the trials are valid and statistically significant.

From 2003 to present, QARC performed reviews on radiation therapy protocols for 6,449 patients enrolled in NCI-supported clinical trials. Cases are reviewed prior to or very early in the radiation therapy course, so that modifications in treatment can be implemented to make the treatment compliant with the study requirements. This study shows that this improved the overall quality of the clinical trial and its potential outcomes.

"Clinical trials are one the most important tools that the cancer research community has to evaluate treatments and protocols in an effort to cure cancer" T.J. FitzGerald, M.D., a study author and a radiation oncologist at QARC, said. "This study shows that a quality assurance program, like ours at QARC, can help cancer researchers conduct better clinical trials. This in turn helps patients get the best treatments possible, while recording the data in a way to help other cancer patients and further help the cancer community better understand what treatments work best."

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