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Quality Assurance Programs Improve Clinical Trials in Cancer

Sep 22, 2008 | Parker Waichman LLP

A study just presented on September 21 at the 50th annual meeting of the American Society for Therapeutic Radiology and Oncology confirms that quality assurance programs help to strengthen the quality of clinical trials.  The study mentioned quality assurance programs such as the one in effect at the Quality Assurance Review Center (QARC), which is located in Worcester, Massachusetts.  The study also said the improvement includes cooperative groups conducting National Cancer Institute-supported clinical trials, which would naturally improve the standard of care in cancer patients.  The meeting took place in Boston, Massachusetts.

A clinical trial is a scientific study that follows a written guideline, or protocol—sometimes referred to as a recipe—for medical treatment and is generally used in the research and treatment of cancer.  As a matter-of-fact, nearly all standard oncology (cancer) treatments originated from such trials.  Clinical trials are the only scientific mechanism designed to test the effectiveness of emerging and promising therapies and provides intensive testing of emerging and updated treatment regimens.

The Quality Assurance Program, provided by QARC at the University of Massachusetts Medical School, was founded in 1980 and includes site credentialing, which is conducted to ensure that those looking to conduct clinical trials have the expertise, equipment, and tools necessary to properly participate in such research trials. The Quality Assurance Program also establishes reference points that are meant to monitor the ongoing trials as well as to provide feedback to the physicians who are conducting the clinical trials.  Monitoring is installed to help ensure that patients involved in clinical trials receive the best treatments possible and that those conducting the trials ensure data derived from the trials are both valid and statistically significant.

From 2003 to present, QARC performed reviews on radiation therapy protocols for 6,449 patients enrolled in National Cancer Institute (NCI)-supported clinical trials.  These cases are reviewed prior to or very early in the course of radiation therapy to ensure that any needed treatment modification can be implemented to bring the treatment into compliance with study requirements.

The study presented this week reveals that this action improved the overall quality of the clinical trial and the trial’s potential outcomes.  "Clinical trials are one of 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."

Cancer clinical trials have long been recognized as a key component in the preventing, diagnosing, and treating of all types of cancer, with an estimated 60% of all cancer patients in the United States being cured.  Despite this, les than three percent of adult cancer patients participate in clinical trials; however, 71% of children enter clinical trials, which has led to major advancements in treatment and high cure rates for many childhood cancers.


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