Early termination of cardiovascular trials as a consequence of poor accrual: analysis of ClinicalTrials.gov 2006-2015.

ABSTRACT:

Objectives

To present a snapshot of experimental cardiovascular research with a focus on geographical and temporal patterns of early termination due to poor accrual.

Setting

The Aggregate Analysis of ClinicalTrials.gov (AACT) database, reflecting ClinicalTrials.gov as of 27 March 2016.

Design

The AACT database was searched for all cardiovascular clinical trials that started from January 2006 up to December 2015.

Results

Thirteen thousand and seven hundred twenty-nine cardiovascular trials were identified. Of these, 8900 (65%) were classified as closed studies. Globally, 11% of closed trials were terminated. This proportion varied from 9.6% to 14% for trials recruiting from Europe and Americas, respectively, with a slightly decreasing trend (p=0.02) over the study period. The most common reason for trials failing to complete was poor accrual (41%). Intercontinental trials exhibited lower figures of poor accrual as the reason for their early stopping, as compared with trials recruiting in a single continent (28% vs 44%, p=0.002).

Conclusions

Poor accrual significantly challenges the successful completion of cardiovascular clinical trials. Findings are suggestive of a positive effect of globalisation of cardiovascular clinical research on the achievement of enrolment goals within a reasonable time frame.

SUBMITTER: Baldi I 

PROVIDER: S-EPMC5577897 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature