Plan Ahead for Delays in Clinical Trial Duration
Although teams plan clinical trial duration timelines, they frequently experience setbacks that cause significant delays. Slower than expected patient recruitment or delays in reaching other milestones can add months to clinical trials. Unfortunately, these delays can be very costly since they force teams to extend site contracts and push back regulatory approval. As such, clinical team executives interviewed for Cutting Edge Information’s report, Clinical Development and Trial Operations, recommend planning for delays during protocol design. Adding anticipated setbacks to trial timelines and setting aside additional resources can reduce costs in the end.
To determine how much additional time teams should plan for, CEI analysts asked surveyed clinical executives how long setbacks typically delay their clinical trial duration. Figure 1 shows the average trial delay, by phase.
Figure 1: Average Clinical Trial Delay, by Phase
- On average, surveyed clinical teams report that Phase 1 trials take 12% longer than planned — the shortest delay during clinical development. It is not surprising that teams report the shortest delays during Phase 1, which are relatively simpler to conduct than later trials. The number of enrolled patients is typically very low during the first trial stage. Teams are generally able to recruit enough patients in time for Phase 1 trials.
- For subsequent phases, teams report roughly a 25% delay in clinical trial duration. Patient enrollment might be the most common cause of setbacks during mid- and late-stage development. Teams need a large number of enrolled patients — particularly during Phase 3 — to conduct trials. Meeting the target patient enrollment numbers can be difficult. In addition, trials can be delayed if too many patients drop out.
Planning for a longer-than-expected clinical trial duration during protocol design can pay off for teams in the long-run. An interviewed company executive reports that extending the expected timeline and increasing the trial budget to account for delays can save resources in the end. By examining past setbacks, teams can project more accurate timelines for future trials.