Batching image submissions in clinical trials: the case against it!
Clinical trials are inherently risk management exercises, where sponsors, CROs and investigators work as a team to determine the effectiveness of a compound or treatment. In the late 1900s, form data submitted by investigators to CROs was sent using the latest in technology: fax. Prior to that, forms were mailed. The advent of EDC systems promised not only to reduce or eliminate data entry errors, but also to enable real time submission of the data to clinical research organizations. It took EDC close to 10 years to enjoy full adoption.
In the early days of EDC, trials allowed for “mixed” submissions, giving sites the option of using electronic submissions or more primitive forms of delivery. This was due to the fact that trial managers feared alienating sites by demanding a change in their existing workflows. After a whole decade that showed how much more efficient were trials using electronic forms with field level validation, projects have moved entirely away from paper forms to the electronic media provided by companies such as Oracle’s InForm, Merge’s Merge EDC or Medidata’s Rave.
Trials involving imaging have been late to the party with respect to submission tools that provide EDC-like benefits. For many years, the status quo for image submissions (e.g., courier shipments or FTP-based systems that aren’t up to the task) induced sites to hold multiple timepoints for their subjects and send all of them at one time. The consequence of delayed submission of images in a trial are many: delays in analysis; possible loss of patients when image data does not meet protocol requirements, delayed findings of adverse effects, etc.
Looking back we must ask ourselves why it took so long for the industry to adopt EDC as a clearly superior way to collect data and enjoy the very positive fruits of the effort to move sites into the new workflow. I believe that one significant reason was fear. The aversion from the industry to introduce sites, sometimes persistently, to better ways to participate in clinical trials creates a kind of progress paralysis based on a misconception that investigators need to be treated with kid gloves and therefore we should not be imposing change upon them.
This of course is a fallacy. Investigators all over the world are aligned with the trial objectives. They want to find the effectiveness of a compound just as much as anyone else. They react negatively to unnecessary overhead. However, as long as they are properly introduced to new and quantifiably better methods for participating in clinical trials, they welcome innovation. In the case of imaging, I have found thousands of trial coordinators in every corner of the globe who willingly invest time when building a submission, if they can be shown that the number of queries back from CROs will be significantly reduced. This certainly requires the right types of tools and not just “a faster way to send things.”
Batching submissions in imaging clinical trials delays trial progress and increases risk unnecessarily. Given the evolution and great benefits of EDC systems, we have an opportunity to increase trial efficiency and submission quality significantly, while reducing cost and risk across entire projects that use imaging as surrogate endpoints.