Analysis of Terminated Hand and Wrist-Related Clinical Trials.

PURPOSE

While clinical trials provide high-quality evidence guiding medical decision-making, early trial termination can result in both lost time and resources. Our purpose was to investigate the rate of and reasons for clinical trial termination for hand and wrist-related conditions and identify study characteristics associated with early trial termination.

METHODS

The ClinicalTrials.gov database was queried for all hand and wrist-related clinical trials. All terminated and completed trials were reviewed, with characteristics and reasons for termination recorded. Study characteristics included type, purpose, intervention assessed, enrollment, group allocation, blinding, trial phase, sponsor type, and geographic region. Chi-square test was used to identify associations between trial characteristics and terminated versus completed status.

RESULTS

A total of 793 hand and wrist-related clinical trials were identified, with 77 trials (10%) terminated prior to completion. The most common reason for termination was "recruitment/retention difficulty," reported in 37 (48%) terminated trials. In comparing competed versus terminated trials, primary purpose (nonobservational studies), enrollment (<50 patients), and geographic region (North America) were all significantly more likely to be terminated. Terminated trials were more likely to have an intervention type investigating a specific device or drug.

CONCLUSIONS

Early trial termination for hand and wrist-related conditions is common (10%), with patient recruitment and retention identified as the leading cause of termination. Trials involving potential commercial incentives (those investigating a device or drug) were associated with an increased rate of trial termination.

CLINICAL RELEVANCE

An emphasis on patient enrollment during study design may aid in mitigating the most common cause of early clinical trial termination.