Three More Challenges Presented by Clinical Trial OCTs; Part 2

Optical Coherence Tomography (OCT) technology provides objective measurement of retinal thickening in the macular region.  However, for the resultant data to be considered reliable, and to be incorporated into a regulatory submission, several technical challenges must be overcome.  We outlined three of these challenges in Part 1. Here are the remaining three challenges:


(4) Measuring and Evaluating Scans in a Standardized and Reproducible Manner

Although OCT measurement data is “objective,” the procedures of different scanner makers and the clinical centers using them can lead to notably different results from similar patients.  This problem is further exacerbated by the complexity of scans in diseased eyes, which can defeat automated measurements and introduce the subjectivity of different clinician interpretation.


(5) Obtaining OCT Scan Data for Timely and Convenient Statistical Analysis

Periodically, sponsors must analyze their data for emerging outcomes and to inform their data monitoring and safety committees. At trial end, sponsors are eager to analyze their results to see if trial objectives have been reached.  OCT scan data coming from multiple sources in different formats are difficult to handle and understand.


(6) Sponsor Submission OCT Scans/Data to Regulatory Agencies Can Be Complicated

If sponsors directly receive OCT data from clinical centers, they may end up with scans in mutually incompatible formats and with variable measurement data resulting from differing software tools and human interventions.  Not only are the differing scans hard for the regulators to manage, the variance in measurement data between systems can undermine confidence in the statistical analysis and the outcome conclusions.

MERIT provides key Contract Research Organization services that facilitate the gathering, analysis, interpretation, and presentation of ocular morphology data, notably OCT imaging results, in animal studies, clinical trials and regulatory submissions.

To read about MERIT’s solutions for these challenges, download our white paper Testing Biosimilar Drugs for Regulatory Approval: The MERIT Advantage.