Trial Disruptions

Monitor 45+ variations of roadblocks such as safety, futility, enrollment problems, and supply chain disruptions and preemptively manage risks to maintain the integrity of your own clinical trials.

Stopped Early

A deviation from its standard trajectory has led to this study's premature cessation. This encompasses trials marked as suspended, terminated, or withdrawn. While the majority of trials follow a predictable progression to completion, some experience unexpected interruptions. Typical reasons include recruitment challenges or a strategic reevaluation by the sponsor. Notably, under 2% of terminated or withdrawn trials restart, but around 44% of suspended trials resume.

Stopped Early: Futility

The study halted due to interim analysis revealing insufficient clinical efficacy or the realization that the trial's design wouldn't achieve the endpoint with the current participant count. Various reasons could lead to futility-based interruptions, like negative primary endpoint analysis, drug failure in another trial, or inadequate sample size. About 7% of early stoppages arise from futility, with Phase 3 trials experiencing it thrice as often.

Stopped Early: Safety

Safety concerns prompted the study's early termination. An institutional review board (IRB) approves trials based on the benefits outweighing potential risks to participants. However, significant adverse events may lead to a study's suspension or termination for reevaluation. Such safety-induced stoppages are rare, accounting for 2% of early terminations, and are most prevalent in Phase 1 trials.

Stopped Early: Regulatory

Regulatory or institutional considerations caused the study's pause. This often results from a clinical hold by regulators or the IRB due to detected safety issues in similar trials. About 4% of all early stoppages arise from regulatory concerns.

Stopped Early: Covid

COVID-19 pandemic disruptions led to the study's early halt. Trials faced challenges like slow enrollment, reduced patient retention, and site limitations. Over 5,400 trials stopped prematurely due to the pandemic, with research institutions bearing the brunt, accounting for 82% of such stoppages.

Stopped Early: Enrollment

The study halted because of enrollment difficulties. Enrollment remains the primary challenge for research institutions. However, even industry trials face enrollment issues, especially in competitive patient demographics or rare diseases. Enrollment-related issues are the predominant reason for early stoppages, impacting a quarter of all such events.

Stopped Early: Funding

Financial constraints caused the study's cessation. Funding-related interruptions account for about 9% of early stoppages, with research institutions facing it more often.

Stopped Early: Personnel Issues

Staffing disruptions led to the study's interruption. Staff-related issues can stem from principal investigators and their teams. Such interruptions account for over 5% of early halts, predominantly in research institution-sponsored trials.

Stopped Early: Strategy: A sponsor's business decision led to the trial's early termination. These account for 10% of all early stoppages, with industry-run trials experiencing it more frequently.

Stopped Early: Competition

Competition in the sector led to the study's interruption. Such disruptions are rare, making up less than 1% of stopped trials.

Stopped Early: Supply

Supply disruptions of the intervention or its key ingredients caused the study's halt. This reason accounts for about 2% of early terminations.

Stopped Early: Investigator Decision

The study's investigator or key personnel decided to stop the trial. Such decisions account for a mere 1% of early stoppages, predominantly affecting academic studies.

Stopped Early: Logistics

Logistic issues, like site or tool problems, led to the study's early cessation. Such reasons make up just over 3% of early terminations.

Stopped Early: Trial Design

The study was halted for potential protocol redesigns. Around 4% of early terminations arise from trial design considerations.

Announcement: Trial Stopped

A public announcement was made regarding the trial's early cessation. Reasons can range from positive interim results to safety concerns. Such announcements are rare, making up less than 1% of clinical press releases detected by AppliedXL.

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