Front Oncol. 2013 Dec 19;3:311.

Quality Assurance for Clinical Trials.

Ibbott GS1, Haworth A2, Followill DS3.

Author information

• 1Department of Radiation Physics, The University of Texas MD Anderson Cancer Center , Houston, TX , USA.
• 2Peter MacCallum Cancer Centre , Melbourne, VIC , Australia.
• 3Radiological Physics Center , Houston, TX , USA.

Abstract

Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution's procedures for planning and delivering advanced external beam techniques (1-3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective.