Discontinuation and nonpublication of pediatric otolaryngology clinical trials

Johnson, Austin; Torgerson, Trevor; Adewumi, Mopileola Tomi; Kee, Micah; Farahani, Clay; Wehrmann, Daniel J; Francis, Carrie L.; Vassar, Matt

doi:10.1016/j.ijporl.2021.110972

Cited by 3 publications

(2 citation statements)

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“…Many challenges exist to the publication of RCTs. There is evidence suggesting that RCTs in surgery, and Otolaryngology -Head and Neck surgery in particular, often fail to reach completion and publication and the reason for discontinuation is seldomly reported (12)(13)(14). The most common reported reason for discontinuation of a surgical RCT was found to be slow recruitment of participants (12).…”

Section: Discussionmentioning

confidence: 99%

Published randomized controlled trials in Otolaryngology: 2016-2020

McNeely,

Heffernan,

Lee

et al. 2024

Preprint

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Importance: To provide a current evaluation of bibliometric trends in the Otolaryngology literature focused on randomized controlled trials (RCTs). RCTs hold an important role in research as bias controlled assessments of clinical interventions. Objective: The purpose of this study is to evaluate the proportion of published RCTs in the Otolaryngology literature. Design: Quality Improvement scoping bibliometric review. Setting: Published articles in eight Otolaryngology journals from January 1, 2016 - December 31, 2020. Main Outcomes and Measures: Included articles were categorized as a RCT, secondary research, other clinical research, case report, primary basic science, or other study type. Additionally, studies were categorized as American, Canadian, British, or other international origin according to the corresponding author’s institutional address. The proportion of published RCTs were compared by national origin and to an earlier bibliometric analysis investigating Otolaryngology journal publications from 2008-2012 using Pearson’s Chi-Squared testing with Bonferroni correction. Results: A total of 6797 articles were reviewed and included for analysis. There was a significant difference in the proportion of RCTs published by national origin, 1.3% USA, 2.2% Canada, 2.7% UK, 3.4% other (p < 0.01). There was a significant decrease in the proportion of RCTs published from 2008-12 to 2016-2020 (3.1% vs. 2.3% respectively, p < 0.01). Conclusions: Although the current study analyzed only a select sample of all Otolaryngology research output, this study suggests that North American researchers are publishing less RCTs than researchers in other countries. Moreover, RCTs are declining as a proportion of the published Otolaryngology literature over time, which is a threat to the evidence base for current and future Otolaryngological practice.

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Section: Discussionmentioning

confidence: 99%

Published randomized controlled trials in Otolaryngology: 2016-2020

McNeely,

Heffernan,

Lee

et al. 2024

Preprint

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“…Given the rapid evolution of orthopaedic surgical practices and standards of care that rely on clinical trials, minimizing early trial discontinuation is imperative to support clinicians in providing evidence-based care to patients 10 . Approximately 12% to 30% of trials have been discontinued across specialties since 1972 4,6,[11][12][13][14] ; however, most of the reasons listed for discontinuing a trial are preventable issues 12 . Therefore, patient outcomes may be improved by identifying specific opportunities to enhance the comprehensiveness of the evidence base generated by orthopaedic surgery clinical trials 10 .…”

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confidence: 99%

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery

Hecht,

Guyler,

Shah

et al. 2023

Journal of Bone and Joint Surgery

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Background: Clinical trials play a crucial role in advancing medical knowledge and have the potential to change standards of care. The present study evaluated the prevalence of discontinued clinical trials in orthopaedic surgery. Additionally, we sought to identify the study characteristics associated with and the rationale behind trial discontinuation. Methods: A cross-sectional survey of orthopaedic clinical trials using the ClinicalTrials.gov registry and results database was performed for trials between October 1, 2007, and October 7, 2022. Interventional trials listed as "completed," "terminated," "withdrawn," or "suspended" were included. Study characteristics were collected and clinical trial abstracts were reviewed in order to assign the appropriate subspecialty category. A univariate linear regression analysis was performed to determine whether the percentage of discontinued trials changed between 2008 and 2021. Univariate and multivariable hazard ratios (HRs) were calculated to identify factors associated with trial discontinuation. Results: A total of 8,603 clinical trials were included in the final analysis, of which 1,369 (16%) were discontinued, with the highest rates of discontinuation found in oncology (25%) and trauma (23%). The most common rationales for discontinuation were insufficient patient accrual (29%), technical or logistical issues (9%), business decision (9%), and lack of funding or resources (9%). Industry-funded studies were more likely than government-funded studies to be discontinued (HR: 1.81; p < 0.001). There was no change in the percentage of discontinued trials for each orthopaedic subspecialty between 2008 and 2021 (p = 0.21). As shown on multivariable regression analysis, trials for devices (HR: 1.63 [95% confidence interval, 1.20 to 2.21]; p = 0.002) and drugs (HR: 1.48 [1.10 to 2.02]; p = 0.013) as well as Phase-2 trials (HR: 1.35 [1.09 to 1.69]; p = 0.010), Phase-3 trials (HR: 1.39 [1.09 to 1.78]; p = 0.010), and Phase-4 trials (HR: 1.44 [1.14 to 1.81]; p = 0.010) had a higher likelihood of early discontinuation. However, pediatric trials were less likely to be discontinued (HR: 0.58 [0.40 to 0.86]; p = 0.007). Conclusions:The results of the present study suggest the need for continued efforts to ensure the completion of orthopaedic clinical trials in order to limit publication bias and to employ resources and patient contributions more efficiently for research. continued Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/H549).

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