Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov registry

Bernardez‐Pereira, Sabrina; Lopes, Renato D.; Carrion, Maria Julia Machline; Santucci, Eliana Vieira; Soares, Rafael Marques; Abreu, Matheus de Oliveira; Laranjeira, Lígia Nasi; Ikeoka, Dimas; Zazula, Ana Denise; Moreira, Frederico Rafael; Cavalcanti, Alexandre Biasi; Mesquita, Evandro Tinoco; Peterson, Eric D.; Califf, Robert M.; Berwanger, Otávio

doi:10.1016/j.ahj.2014.04.013

Cited by 78 publications

(110 citation statements)

References 16 publications

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“…Compared to completed studies, discontinued studies were more likely to be non-comparative (33% vs 27%) and single centre (83% vs 76%). Another study was based on cardiovascular studies registered in ClinicalTrials.gov [7]. Again, slow recruitment was the main reason for study discontinuation.…”

Section: Discussionmentioning

confidence: 99%

“…Pilot or feasibility NPSs conducted on selected populations may be less prone to discontinuation due to poor recruitment than confirmative RCTs that need to achieve a certain sample size to establish the effectiveness of a treatment. A study on a sample of cardiovascular trials registered in ClinicalTrials.gov showed that besides funding by federal agencies and behavioural therapies, a single arm study design is associated with a lower risk of early termination due to poor recruitment [7]. Furthermore, studies suggest that it is easier to recruit participants into NPSs [8, 9].…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, studies suggest that it is easier to recruit participants into NPSs [8, 9]. On the other hand, NPSs may be more frequently explorative in nature including first-in-human studies or early pharmacological studies [7]. Those studies are typically surrounded by more uncertainties concerning the potential benefit and harms an intervention could have for patients, and may thus bear a higher risk for discontinuation.…”

Section: Introductionmentioning

confidence: 99%

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Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

et al. 2016

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BackgroundPremature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear.ObjectivesTo compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.MethodsWe systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.ResultsOf 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%).ConclusionsCompared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

et al. 2016

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“…Focusing specifically on cardiovascular trials, Bernardez-Pereira et al 3 confirmed that slow enrollment is the most common reason for study termination. Their analysis suggests that the rate of termination for cardiovascular trials (10.9%) is similar to the overall rate reported by Williams et al, 2 but that insufficient recruitment may be a more pressing issue: an estimated 53.6% of terminated cardiovascular trials were terminated due to slow patient accrual.…”

Section: See Related Article Pp 507-517mentioning

confidence: 88%

Statistical issues associated with terminating a clinical trial due to slow enrollment

Morgan

2017

Journal of Nuclear Cardiology

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“…A major challenge in conducting such studies is the timely recruitment of subjects who meet study entry criteria (5, 6). Delayed recruitment has many consequences - delayed results, increased cost, early termination, and wrong conclusions (7).…”

Section: Introductionmentioning

confidence: 99%

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research

Tan

Bernstein

Gendler

et al. 2016

Contemporary Clinical Trials

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Background and Aim A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). Method A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. Results After 5 years, the DRR has over 5,000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. Conclusion The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies.

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Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov registry

Cited by 78 publications

References 16 publications

Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

Statistical issues associated with terminating a clinical trial due to slow enrollment

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research

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