The information available regarding the efficiency and effectiveness of imaging clinical trials indicates that data quality is a significant factor in the overall poor performance of these trials. Data loss estimates in the 30% range have been verified across the industry and do not appear to vary greatly by phase, therapeutic area, or intervention type.
The increasing utilization of adaptive trial designs, development of novel imaging biomarkers, and continual technological advancements in imaging modalities make this lack of efficiency and effectiveness evermore troubling. Studies must be over-enrolled and scheduled for longer periods of time to compensate for these deficiencies. The ability to make accurate go/no-go decisions is delayed and perhaps compromised. The altruistic contribution of study patients is wasted and their care may be affected. R&D funds that could be better allocated elsewhere are spent ineffectively.
A review of the various players or stakeholders present in an imaging clinical trial and an analysis of the flows of data, money, and information indicate that solutions to address at least some of these issues need not be complex or overly technical. The key issues of data quality and timeliness may be addressable via relatively simple adjustments that improve communications and logistics amongst and between the stakeholders.
Because it is critical to the serial review of on-study images, an example of a simple solution is to focus attention on the baseline imaging visit. Any errors that occur around this initial timepoint significantly impact the value of the patient’s data for the rest of the study and generally result in censoring of all or a portion of the subsequent dataset. Therefore, instituting training, communications, and workflow modifications that underscore to all stakeholders that critical nature of this one visit could have a direct and positive impact on data quality.