Click here to


Are you sure ?

Yes, do it No, cancel

Have Benchmarks and Pre-Treatment Reviews Impacted the Clinical Trial Deviation Rate?

J Lowenstein*, H Nguyen , J Roll , D Followill , UT MD Anderson Cancer Center, Houston, TX


(Sunday, 7/14/2019)  

Room: ePoster Forums

Purpose: The mission of IROC Houston is to assure the NCI that participating institutions deliver prescribed radiation doses that are clinically comparable and consistent. This is accomplished through credentialing, and pre-treatment and post-treatment reviews of submitted patient data. In 2016, IROC Houston began tracking the results of the aforementioned credentialing techniques to determine their impact on clinical trial deviation rates.

Methods: In this study we looked at the deviation rates for benchmarks, pre-treatment, and post-treatment reviews. Benchmarks are performed prior to enrolling a patient on study. Pre-treatments are completed prior to the start of a patient’s treatment. Post-treatment reviews are completed post treatment. All 3 types of reviews were performed using anonoymized DICOM data and MIM software tools.

Results: Over the past 18 years the major deviation rate has remained consistent for post-treatment reviews, minor variations have increased and per protocol agreement has decreased. During the past 3 years, pre-treatment and benchmarks show a major deviation rate of 21% and 13%, respectively, and minor deviation rate of 23% and 33%, respectively. The decrease in deviation rates over the past 18 years is not unexpected since the purpose of the benchmark and the pre-treatment review is to educate and correct any errors made before a patient is actually treated on a protocol.

Conclusion: Over the last two decades technology and delivery mechanisms have become more complex as have clinical trial protocols. Through the use of benchmarks and pre-treatment reviews, we have been able to educate institutions on how to contour and plan according to protocol specifications. Through this process we have been able to increase the rate at which institutions complied with the protocol, thereby affirming that the dose delivered to protocol patients are consistent with what the protocol intended to be delivered.

Funding Support, Disclosures, and Conflict of Interest: Work supported by grant U24 CA180803 awarded by NCI, DHHS.


Quality Assurance, Clinical Trials


TH- External beam- photons: treatment planning/virtual clinical studies

Contact Email