Recently, I was perusing clinical trial news and saw a reference to a heart valve study that lasted 25 years. I can’t even fathom a 25 year study. I can’t even fathom at some level the logistics that are required to collect and manage all that data, track patients properly, maintaining consistency – what a herculean effort!
ImageIQ and IMARC Research recently had a very successful webinar discussing the risks that imaging introduces into a clinical trial. One of the topics we discussed in the webinar was trial length – the longer the trial, the more risk is encountered. There’s no doubt that imaging adds complexities – image tracking, dealing with different staff capabilities who acquire them, managing factors related to images that are acquired from different modalities, and ensuring that protocols are consistent…to name a few.
With that in mind, here are some things you can do to mitigate your risk – and it really is a matter of organization.
Store images electronically. I can’t tell you how many times we’ve received boxes of CD’s and DVD’s that contain images. Although this is a traditional way of doing this, it opens one up to risks like data loss (i.e., misplaced shipment), among others. This approach also increases the time it takes to access the data, especially if the CDs/DVDs are located off-site. So if you are doing a trial of any kind of length, make the investment to store your images electronically, it will absolutely pay off in the long run.
It’s all about the protocol. The best way to mitigate risk is to write a very crisp, clean and well-reviewed imaging protocol. If you have a long running trial, having a focused imaging protocol will be absolutely critical for you to ensure that over the course of time you receive images that are relevant to the study that you are trying to perform and of consistent quality. There is nothing more frustrating than collecting a lot of images that will never yield good, reliable data.
Quality check milestones. Establish a regular quality check throughout the course of the trial. I would even go as far as saying you could call it a quality protocol. Include details for checking the image quality coming in per site, per imaging modality type that you are acquiring and, also consider revaluating the inter- and intra-reader (e.g., radiologist, pathologist, etc.) variability of your image evaluation protocol. I think that will go a long way.
If you’d like to get some more information about this, Sandra Maddock from IMARC Research and I did a webinar on risks in imaging clinical research, and obviously covered a lot more that I can cover in this short blog. Click here to access the webinar recording.