TY - JOUR
T1 - Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment
T2 - Insights from the ClinicalTrials.gov registry
AU - Bernardez-Pereira, Sabrina
AU - Lopes, Renato D.
AU - Carrion, Maria Julia Machline
AU - Santucci, Eliana Vieira
AU - Soares, Rafael Marques
AU - De Oliveira Abreu, Matheus
AU - Laranjeira, Ligia Nasi
AU - Ikeoka, Dimas T.
AU - Zazula, Ana Denise
AU - Moreira, Frederico Rafael
AU - Cavalcanti, Alexandre Biasi
AU - Mesquita, Evandro Tinoco
AU - Peterson, Eric D.
AU - Califf, Robert M.
AU - Berwanger, Otavio
N1 - Funding Information:
In summary, early termination of cardiovascular clinical trials is common, and low recruitment represents the most frequent reason for early termination. Trials funded by the NIH and other US federal agencies and trials of behavior and diet interventions face a lower risk of early termination due to low recruitment. Our findings may contribute to a better understanding of the etiology of premature trial termination due to low enrollment and could also set the stage for targeted approaches to improve clinical research recruitment.
PY - 2014/8
Y1 - 2014/8
N2 - Background Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination. Methods We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. Results Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. Conclusions Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.
AB - Background Early termination of clinical trials due to low recruitment represents an understudied challenge for clinical research. We aimed to describe characteristics of cardiovascular trials terminated because of low recruitment and identify the major predictors of such early termination. Methods We reviewed all cardiovascular clinical trials (7,042 studies) registered in ClinicalTrials.gov from February 29, 2000, to January 17, 2013, and assessed information about trials that were completed and those that were terminated early. Logistic regression models were developed to identify independent predictors of early termination due to low recruitment. Results Our search strategy identified 6,279 cardiovascular clinical trials, of which 684 (10.9%) were terminated prematurely. Of these halted trials, the main reason for termination was lower than expected recruitment (278 trials; 53.6%). When comparing trials that terminated early because of low recruitment with those that were completed, we found that studies funded by the National Institutes of Health or other US federal agencies (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.14-0.89), studies of behavior/diet intervention (OR 0.35, 95% CI 0.19-0.65), and single-arm design studies (OR 0.57, 95% CI 0.42-0.78) were associated with a lower risk of early termination. University/hospital-funded (OR 1.52, 95% CI 1.10-2.10) and mixed-source-funded studies (OR 2.14, 95% CI 1.52-3.01) were associated with a higher likelihood of early termination due to lower than expected recruitment rates. Conclusions Low recruitment represents the main cause of early termination of cardiovascular clinical trials. Funding source, type of intervention, and study design are factors associated with early termination due to low recruitment and might be good targets for improving enrollment into cardiovascular clinical trials.
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U2 - 10.1016/j.ahj.2014.04.013
DO - 10.1016/j.ahj.2014.04.013
M3 - Article
C2 - 25066561
AN - SCOPUS:84905121663
SN - 0002-8703
VL - 168
SP - 213-219.e1
JO - American heart journal
JF - American heart journal
IS - 2
ER -