Per FDA guidelines, it’s important to have standardized medical imaging criteria to capture the response of a tumor to an oncology treatment. RECIST is this standard for solid tumors – introduced in 2000 and revised in 2009 to become RECIST 1.1. 
RECIST criteria is not always reported accurately, and variability in tumor response assessment may be disastrous for measuring true treatment effect.
In one report, a Phase II clinical trial that used local investigators, blinded independent central review, and adjudicators was analyzed by looking at the discrepancies of RECIST 1.1 assessments. According to the report, “the adjudication rate at declaring progressive disease per patient was 36.7%.” 
Report authors found that variability resulted primarily from differences in reporting new lesions, along with the measured change of the tumor burden and the progression of non-target lesions. The authors cite advanced training, stringent annotation quality control, and the use of technology as possible methods to further improve the consistency of reads and reduce adjudication rate.
Images are either interpreted at a clinical site, centralized facility that receives images from clinical sites, or both – and there is no one-size-fits-all best approach to reads. Trial design features, blinded vs. unblinded image interpretation, and the specific vulnerabilities of different imaging modalities, along with other factors, all play a role in selecting the best approach for your study.
How can sponsors and CROs work to ensure consistency in RECIST reads?
From the beginning, clinical teams should be involved in CRF development. During the site initiation visit, robust training and clear instruction should be provided to the clinicians regarding methods used for tumor measurements. As RECIST is generally a trial endpoint, consistency in tumor measurements is critical to avoid variability across the study. Providing instructions only in the CRF Completion Guidelines will not ensure that the data are properly captured within the source, and this will impact the quality of data.
Monitoring should be provided by CRAs trained in monitoring oncology trials. These CRAs need to understand the pathology, diagnosis, and treatment of cancer to effectively engage with study site personnel and ask the necessary probing questions when reviewing patient charts.
In addition to including the clinical project manager in CRF development, the lead data manager, biostatistician, and sponsor should collaborate to help ensure that necessary details will be captured in a manner which supports analysis.
Successful collection usually involves:
In the case of studies that are utilizing both local investigators and a blinded independent review, the biometric team should work closely with the blinded review committee to ensure all pertinent tumor details are included for evaluations.
Biostatisticians should be involved with data cleaning early to aid in ensuring accuracy of RECIST grading before sites are closed. There should also be a programmatic derivation of RECIST grading based on the target tumor measurements, non-target tumor status (either individually or the investigator determined non-target response), and new tumor information. Concordance between the local investigator evaluations and/or blinded independent review evaluations, and the evaluations derived by the biometrics team should be evaluated at regular intervals and re-training given where appropriate.
The Best Overall Response and other parameters based on the RECIST grading are best derived by the biometric team and not collected in the CRF/blinded independent review. The values are subject to change over time with each new assessment, depend heavily on the accuracy of the RECIST grading itself, and collecting in the database adds to the data cleaning burden without providing additional benefit.
Ensuring the accuracy and consistency of reads is critical to study success. With the right planning and a team that has experience with RECIST reads, your study can be completed efficiently and successfully.
The PharPoint Research team has extensive experience within solid tumor studies and RECIST 1.1. For more information about our team and how we can assist you, contact our business development team.
 Beaumont, H., Evans, T.L., Klifa, C. et al. Discrepancies of assessments in a RECIST 1.1 phase II clinical trial – association between adjudication rate and variability in im-ages and tumors selection. Cancer Imaging 18, 50 (2018).
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