Quality assurance programs improve clinical trials

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BOSTON—Quality assurance programs, such as those provided by the Quality Assurance Review Center (QARC), strengthen the quality of clinical trials, including cooperative groups conducting National Cancer Institute (NCI)-supported clinical trials, according to a study presented Sunday at the 50th annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO).

The Quality Assurance Program, provided by QARC at the University of Massachusetts Medical School in Worcester, 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, according to researchers.

They reported that the program also establishes benchmarks to monitor and provide feedback to the physicians conducting the ongoing trials. The 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.

“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,” said T.J. FitzGerald, MD, a study author and a radiation oncologist at QARC. “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.”

The researchers found that shows that this improved the overall quality of the clinical trial and its potential outcomes.