Interacting with NCTN Groups and protocol PIs, IROC conducts patient case reviews, ensuring that the reviews are timed according to the needs of the specific protocol and that they are performed in a timely and efficient manner.
Case Review for Imaging Trials
IROC imaging QA Centers provide a variety of levels of central imaging review, from retrospective and batch reviews to the real-time and instantaneous reviews required to guide protocol-specified therapy (eg, selection of treatment arm, RT planning). The National Clinical Trials Network (NCTN) Groups benefit from an infrastructure that provides the following services:
- Rapid centralized review in a low-cost environment (eg, eliminating travel requirements)
- Training on the use of appropriate software, protocol details, timelines, and communication procedures
- Validation of expected skills based on completion of an assessment procedure
- Arbitration and qualified backup reader capabilities as a fail-safe mechanism for trials with time-sensitive image review results
- The use of clinically relevant commercial workstations, including those with advanced visualization 3D and RT integration capabilities
Case Review for RT Trials
RT case review, designed to provide feedback to sites as to how closely RT performance met protocol specifications, focuses on technical factors (eg, dose distribution) and clinical factors (eg, prescription and target/critical structure segmentation). As a combined effort, QA Center staff and NCTN Group investigators perform the following three types of RT case review:
- Pre-treatment: Web-based case review of either all or a selected subset of patients identify whether the planned treatment meets protocol specifications before patient treatment begins.
- On-treatment: This review type is performed within a 7-day period, with results communicated to the site after the start of treatment for the purpose of improving overall treatment.
- Post-treatment: IROC provides a wide range of post-treatment reviews, which may include the following:
- Dosimetric evaluation of the actual treatment
- Clinical evaluation of target and normal structure
- Review of modifications made after the initial review