By Tim Kulbago, Vice President, Imaging, ERT
One of the great promises of technology is that it can simplify our lives. The need for it to do so is particularly strong in clinical research, where trials have been growing ever more complex. This is due, in part, to regulators’ increasing requests for the inclusion of imaging analysis when evaluating clinical trial data. In fact, the demand for imaging in clinical trials has increased by 700 percent since 2001. This trend extends beyond oncology trials to include any number of therapeutic areas such as the central nervous system, dermatology, and the musculoskeletal system. Imagine, for example, the challenges in managing the imaging data points for 475 patients in a Phase III oncology trial in which there are primary, secondary, and/or exploratory endpoint measures taken at six time points, with two hundred images per time point. These 2850 imaging sets, containing over 500,000 images, must be interpreted by qualified individuals using software in a way that is compliant with regulatory guidelines, and each measurement and observation must be documented and auditable.
Unless sponsors make use of the proper software tools, the use of imaging in clinical trials can create exponential increases in workloads ― and in opportunities for error and non-compliance. The right technology can, however, dramatically improve compliance, efficiency, and visibility in trials involving imaging. For instance, when technology-enabled reads are used in oncology trials, read time is cut in half and transcription errors are nearly eliminated.