Clinical trials face a significant challenge beyond recruitment: protecting patient enrolment once participants have agreed to join. While awareness and access are essential, operational issues during screening can derail participation, even for willing patients.
The problem often lies in the execution phase. Incorrect instructions, mishandled samples, or unresolved lab queries can lead to lost enrolment opportunities. Biological samples are especially vulnerable because so much must happen correctly before testing can begin. Published literature has estimated that up to three-quarters of errors affecting sample viability occur during the preanalytical phase, before analysis begins.
A biological sample’s journey is fraught with potential pitfalls. Time-sensitive shipments may be lost or delayed, while processing errors, mislabeling, or incorrect accessioning can render samples unusable. It’s estimated that one in five samples collected during clinical trials are compromised before they can be used.
During screening, sample issues may require recollection, delaying eligibility confirmation. Undetected errors can lead to unreliable results, causing eligible participants to be incorrectly screened out. The consequences are particularly severe in rare disease research, where the participant pool is small and geographically dispersed.
In rare disease trials, losing a single participant due to operational issues can be devastating. A global Phase 3 study highlighted the impact of timely visibility and intervention. By identifying and resolving 25 risks to randomization, including laboratory queries, testing holds, incorrect patient instructions, and sample accessioning errors, it preserved approximately one month of enrolment time.
This study’s screening results demonstrated its approach’s value. With a screen-failure rate of 38% compared to the expected 50%, 58 patients remained in the enrolment pathway. It also achieved a rescreen rate of 8%.
People enter clinical trials because they hope the treatment may benefit them, because they want to advance medical research, or both. In doing so, they accept uncertainty and risk, often while managing a serious illness and committing significant time and effort. When operational issues compromise sample integrity or force participants to repeat screening, patients bear the consequences. Their time is lost, their contribution is diminished, and they may face additional burdens or decide to withdraw from the trial.
