Frequency, characteristics, and reasons for termination of cerebral palsy clinical trials.

Abstract

Background: Cerebral palsy is a common neurodevelopmental disease. Clinical trials are essential to improve care for these patients, and trial termination can have a significant effect on progress.

Objective: To investigate the frequency, characteristics, and reasons for termination for cerebral palsy clinical trials.

Design: Retrospective review.

Setting: Database.

Main outcome measures: The ClinicialTrials.gov database was queried for all completed and terminated studies surrounding cerebral palsy. Trial characteristics and the reasons for termination were determined. Univariable and multivariable analysis was performed to determine independent predictive factors for termination of these clinical trials.

Results: A total of 717 clinical trials were identified, of which 49 (6.8%) were terminated. The most common reasons for termination were recruitment/retention issues (26.5% of terminated trials), administrative/conduct reasons (20.4% of terminated trials), and scientific data from the trial (12.2% of terminate trials). On multivariable analysis, industry sponsorship was independently associated with termination (odds ratio, 3.25; p = .047). No other factors were associated with trial termination.

Conclusions: Cerebral palsy clinical trials are terminated at a rate of 6.8%. The primary reason for trial termination was related to recruitment/retention issues, and the only factor that was predictive of termination was industry sponsorship. These reasons and factors should be considered when starting a clinical trial to minimize potential risk of premature termination.