Patient recruitment and selection for certain indications can be challenging - especially if the condition is rare and the patient population is widely distributed. Because this scenario involves more risk than usual with respect to recruiting and retaining the correct patients, the sponsor asked Cronos to closely monitor enrollment risk signals.
In this case example, we identified a site that was recruiting patients with surprising speed. This was a concern for two reasons: the disorder was relatively rare and the rate of recruitment was two standard deviations above the average rate of recruitment for the trial. Furthermore, all patients met inclusion criteria at the very low end of inclusion.
Because of the aggregate risks identified we initiated a Cronos Clinical Review. A Clinical Review is a process by which Cronos determines the credibility of outcome measure scores. In each of the identified problematic cases we determined that the administration of the primary outcome measure was performed improperly and had led to the rapid recruitment of inappropriate patients.
Cronos escalated the findings to the sponsor immediately and a near real-time decision was made to discontinue enrollment at the site.