Treatment Discontinuation Rate

This KRI flags sites and countries with unexpectedly high premature treatment discontinuation rates which are calculated as the total number of subjects discontinuing treatment prematurely for the site/country relative to the cumulative number of subjects randomized/enrolled for the site/country.

Steps to Perform the Review

  1. In the KRI Report by Country, review the Subject Study Discontinuation Rate scatter plot for outlier countries in red.

    Here the country has been flagged with a high treatment discontinuation rate; however, in this case, although the rate is 20% of subjects having discontinued treatment prematurely, it is only due to 1 out of 5 subjects which is not a trend. In this case, no escalation would be warranted.

    Treatment discontinuation country scatter plot

  2. In the KRI Report by Site, review the Premature Treatment Discontinuation Rate scatter plot for outlier sites.

    Site 13419 had 13 out of 13 subjects prematurely discontinue treatment i.e., 100% treatment discontinuation rate. The site has not enrolled any additional subjects since the initial snapshot on 15Dec23, when all subjects had already discontinued treatment.

  3. In determining if escalation is warranted, assess if any action has already been taken to address this rate, and the site’s status. Note in this case, the site is closed and so no additional action can be taken. It may be in this case that the site was being closed and so all subjects were discontinued from treatment for that reason. This is a good example of the importance of viewing the broader picture vs simply escalating what appears to be a strong signal.

    Treatment discontinuation site scatter plot

    Treatment discontinuation trend