Study Discontinuation Rate

This KRI flags sites and countries with unexpectedly high study discontinuation rates which are calculated as the total number of subjects discontinuing study for the site/country relative to the cumulative number of subjects randomized/enrolled for the site/country. Note, for oncology studies this may exclude participants that have died while these participants are included in non-oncology studies.

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Steps to Perform the Review

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

   Before confirming action is required at the country level, assess how many subjects are contributing to the trend.

   The country shown here, in the initial CM review was flagged red, but this was based only on 1 subject out of 12 which does not warrant escalation (1 subject is not a trend). Over time the number of prematurely discontinued subjects remained at 1 while the number of enrolled subjects grew, thus dropping the rate below the threshold. While we should evaluate every red signal, this illustrates the importance of considering the numerator and denominator values.

   

2. In the KRI Report by Site, review the Study Discontinuation Rate scatter plot for outlier sites in red.

   Site 24576 has had 3 out of 7 subjects prematurely discontinued from study. Looking deeper at the trend, this site has worsened significantly over the past month, with all 3 subjects discontinuing during that period. Depending on the reasons for discontinuation this likely warrants escalation for the CRA to investigate any potential mitigations to prevent the remaining 4 subjects from prematurely discontinuing.

   Before escalating, review the reasons for study discontinuation and consider any study-specific requirements for subject discontinuation (as per protocol). If the subjects were discontinued for reasons required per protocol, the site would not warrant escalation.