Beginning with the end goal in mind, it is critical when considering using imaging data to support your clinical trial. Numerous details should be thoroughly addressed prior to starting the trial including, but not limited to the following:
- selection of an appropriate imaging core laboratory with core lab physician review of the imaging protocol and case report forms. This will help to ensure the imaging modalities are appropriate and that the benefits and limitations of the modalities are maximized and mitigated, respectively;
- selection of appropriate clinical sites, with specific attention paid to the credentials of the imagers at the sites, and to understanding each institution’s network and imaging workflow, referral patterns, and available imaging equipment;
- creation and implementation of an Imaging Quality Program that actively trains and qualifies clinical site research coordinators and the imager within the various departments; and
- the ability to track the site-submitted imaging for adherence to the trial’s imaging protocol and to understand the quality of the data submitted by the imaging core laboratory. Re-training may be needed depending on the clinical sites’ imaging quality.
From the sponsor’s viewpoint, receiving poor quality imaging data sets is as bad or worse than receiving no imaging data at all. Regardless of what the clinical trial is studying, patients generally agree to participate with the expectation that all people and companies involved will put forth their best effort to help them, and perhaps advance medicine specific to the disease that is afflicting them. When the primary outcome measure of a study depends on imaging, it is imperative that the imaging be done properly and be of the highest possible quality.
To have a broader discussion regarding the above items or other questions you may have regarding the utilization of imaging to support your clinical trials please contact MED Institute via our website at http://www.medinstitute.com.