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

Baldi, Ileana; Lanera, Corrado; Berchialla, Paola; Gregori, Darío

doi:10.1136/bmjopen-2016-013482

Cited by 31 publications

(28 citation statements)

References 19 publications

(16 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The median time overall was 10 years (i.e., after 10 years half of all studies had been published) with an approximate 95% confidence interval of [8,1], and 4 years (95% CI [4,5]) for studies that were actually published. The latter, however, is an underestimate of the true time to publication as it is biased by 'conditioning on the future' [36]; that is, only including studies for which the outcome was successful.…”

Section: Two-state Modelmentioning

confidence: 99%

See 1 more Smart Citation

A multi-state model analysis of the time from ethical approval to publication of clinical research studies

et al. 2020

View full text Add to dashboard Cite

Background Results of medical research should be made publicly available in a timely manner to enable patients and health professionals to make informed decisions about health issues. We aimed to apply a multi-state model to analyze the overall time needed to publish study results, and to examine predictors of the timing of transitions within the research process from study initiation through completion/discontinuation to eventual publication. Methods Using a newly developed multi-state model approach, we analysed the effect of different study-related factors on each of the transitions from study approval to eventual publication, using a data set of clinical studies approved by a German research ethics committee between 2000 and 2002. Results Of 917 approved studies, 806 were included in our analyses. About half of the clinical studies which began were subsequently published as full articles, and the median time from study approval to publication was 10 years. Differences across model states were apparent; several factors were predictive of the transition from study approval to completion, while funding source and collaboration were predictive of the transition from completion to publication. Conclusions The proposed multi-state model approach permits a more comprehensive analysis of time to publication than a simple examination of the transition from approval to publication, and

show abstract

Section: Two-state Modelmentioning

confidence: 99%

“…However, there are several barriers inhibiting the translation of research knowledge into practice. Firstly, a large proportion of clinical studies are prematurely discontinued [2][3][4][5][6][7][8][9]. Secondly, not all research findings are ultimately published in peer-reviewed journals [10].…”

Section: Introductionmentioning

confidence: 99%

A multi-state model analysis of the time from ethical approval to publication of clinical research studies

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Participant recruitment and retention have been referred to as “the most difficult and challenging aspect of clinical trials.” [ 1 ] Indeed, over 40% of National Cancer Institute-sponsored clinical trials were never completed, typically due to difficulties with trial enrollment [ [2] , [3] , [4] , [5] ]. Even when investigators successfully reach their target enrollment, they rarely do so on schedule [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

A pilot randomized trial of five financial incentive strategies to increase study enrollment and retention rates

Krutsinger

Yadav

Cooney

et al. 2019

Contemporary Clinical Trials Communications

View full text Add to dashboard Cite

Background Enrollment and retention difficulties remain major barriers to conducting clinical trials. Financial incentives may promote clinical trial enrollment, however delivery methods to maximize enrollment, maximize retention, and minimize cost remains uncertain. Methods We conducted a single-blind, web-based randomized controlled trial of five financial incentive strategies on enrollment and retention rates in a longitudinal study of advance directives among community-dwelling older adults. Participants were eligible to receive a fixed total financial incentive, but the disbursement amounts at each study timepoint (baseline, 2-weeks, 4-weeks, and 6-weeks) differed between study arms. At each timepoint, participants completed a different advance directive. We conducted an intention-to-treat analysis for the primary and secondary outcomes of enrollment and retention. Results 1803 adults were randomized to one of five incentive strategies: constant n = 361; increasing n = 357; U-shaped n = 361; surprise n = 360; self-select n = 364. Overall, 989 (54.9%) participants elected to enroll in the advance directive study. There were no differences in enrollment rates between the control (constant 53.5%) and any of the four intervention study arms (increasing 54.3%, p = 0.81; U-shaped 57.3%, p = 0.30; surprise 56.9%, p = 0.35; and self-select 52.2%, p = 0.73). There were no differences in retention rates between the control (constant 2.1%) and any of the four intervention study arms (increasing 5.2%, p = 0.09; U-shaped 3.9%, p = 0.23; surprise 2.4%, p = 0.54; self-select 2.1%, p = 0.63). Conclusions Financial incentive programs for trial enrollment informed by behavioral economic insights were no more effective than a constant-payment approach in this web-based pilot study.

show abstract

“…Such termination raises of variety of ethical, financial, and scientific concerns. [1][2] Most terminations appear to be the result of factors not involving interim analysis of trial results. 3 However, in the ophthalmology literature, there is a gap of knowledge related to the reporting of these trial results.…”

Section: Introductionmentioning

confidence: 99%

Premature termination of interventional ophthalmology clinical trials from international registries

et al. 2019

View full text Add to dashboard Cite

Globally, a multitude of interventional clinical trials are terminated prior to completion. We sought to identify and analyze trends related to the reporting of these trial results. We conducted a retrospective, cross-sectional study of interventional clinical trials in the 16 primary registries of the World Health Organization Network as well as ClinicalTrials.gov dating back to 2003. A total of 250 studies were identified, of which 135 (54%) were sponsored by academic institutions. A staggering 244 trials (98%) did not lead to publication of results. In sum, a total of 22,420 patients participated in clinical research from which the results were not widely disseminated. 75% of trials were discontinued for unspecified or unclear reasons; 10% were terminated due to inadequate patient accrual. New policies and initiatives have helped usher in an era of improved methods for trial reporting and, in turn, provided the opportunity to perform more interventional trials. However, further action is needed to ensure that findings of all trials are shared with the ophthalmic community in order to build a more comprehensive body of knowledge and decrease potential redundancy.

show abstract

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

Cited by 31 publications

References 19 publications

A multi-state model analysis of the time from ethical approval to publication of clinical research studies

A multi-state model analysis of the time from ethical approval to publication of clinical research studies

A pilot randomized trial of five financial incentive strategies to increase study enrollment and retention rates

Premature termination of interventional ophthalmology clinical trials from international registries

Contact Info

Product

Resources

About