Discontinuation and non-publication rates of U.S. clinical trials for the pharmacologic treatment of type 2 diabetes mellitus: A cross-sectional analysis

Howard, Conner; Sajjadi, Nicholas B; Shepard, Samuel; Waddell, Jourdan; Chronister, Stacy; Vassar, Matt; Hartwell, Micah

doi:10.1016/j.diabet.2021.101317

Cited by 3 publications

(4 citation statements)

References 6 publications

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“…Con rming our hypothesis, our cross-sectional analysis of the ClinicalTrials.gov database found a substantial rate of discontinuation among clinical trials in the eld of orthopaedic oncology, with 19.2% of the evaluated trials being discontinued (Table 1). This nding was in alignment with prior discontinuation investigations in various elds of medicine, which demonstrate discontinuation rates between 10-30% 12,14,17 . High rates of discontinuation may be attributed to a variety of factors, such as recruitment di culties, moral dilemmas, safety worries, operational challenges, and limited resources 14 .…”

Section: Discussionsupporting

confidence: 86%

“…Logistic regression adjusted for funding source, intervention, and enrollment size, similar to prior studies 3,22 . Adjusted Odds Ratios (AOR) with their corresponding 95% Con dence Intervals (CI) and p-values were calculated to determine the signi cance of the association.…”

Section: Methodsmentioning

confidence: 97%

“…Trials with enrolling, not recruiting, or active status were excluded from the analysis. Studies were excluded if they were not relevant to orthopaedic oncology, were not Phase 3 or 4 trials, or if the trial was completed after May 1, 2020 due to publication lag 13,17 . Phase 0, 1, or 2 studies were excluded, as they are not commonly intended for translation to clinical care in the context of orthopaedic oncology 16,18,19 .…”

Section: Methodsmentioning

confidence: 99%

“…Phase 0, 1, or 2 studies were excluded, as they are not commonly intended for translation to clinical care in the context of orthopaedic oncology 16,18,19 . The completion date is when the nal participant in the study was examined or received a treatment to collect nal data for the primary aim measures, secondary aim measures, and adverse outcomes 13,17 . No limitations were implemented for patient age or demographic information to ensure the largest sample size of randomized controlled trials.…”

Section: Methodsmentioning

confidence: 99%

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Discontinuation and Nonpublication of Clinical Trials in Orthopaedic Oncology

Singh,

Wague,

Arora

et al. 2023

Preprint

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Background: This study conducted an analysis examining clinical trial discontinuation rates, associations between intervention types and discontinuation/nonpublication, and the role of funding, enrollment size, and their implications for trial success and completion. Methods: We analyzed ClinicalTrials.gov on May 1, 2023, for phase 3 and 4 randomized controlled trials (RCTs) pertaining to orthopaedic oncology. Trial completion status was assessed using publicly available data on ClinicalTrials.gov. Publication status was also assessed on ClinicalTrials.gov, and by utilizing PubMed (MEDLINE, Google Scholar, and Embase). Results: Among the cohort of 130 trials, 19.2% were prematurely discontinued. Completion rates varied based on intervention type; 111 pharmaceutical trials demonstrated a completion rate of 83.8%, whereas 19 non-pharmaceutical trials exhibited a completion rate of 8.0% (P<.001). Surgical trials, totaling 10, showed a completion rate of 90%. The overall trial publication rate was 86.15%, with pharmaceutical interventions achieving a publication rate of 91.96%. Larger-scale trials (≥261 participants) emerged as a protective factor against both discontinuation (Adjusted Odds Ratio [AOR]: 0.85, 95% Confidence Interval [CI]: 0.42–0.95) and nonpublication (AOR: 0.19, 95% CI: 0.13–.47), compared to smaller-scale trials. Conclusion: Our examination of orthopaedic oncology clinical trials underscores the imperative to confront the challenges linked with trial discontinuation and nonpublication. This study accentuates the heightened vulnerability of non-pharmaceutical interventions and trials exhibiting lower rates of enrollment to the issues of discontinuation and nonpublication. Moving forward, the advancement of clinical trials necessitates a concerted effort to enhance trial methodologies, especially concerning nonpharmaceutical interventions, along with a meticulous refinement of participant enrollment criteria.

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Section: Discussionsupporting

confidence: 86%

Section: Methodsmentioning

confidence: 97%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Discontinuation and Nonpublication of Clinical Trials in Orthopaedic Oncology

Singh,

Wague,

Arora

et al. 2023

Preprint

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Time to publication for results of clinical trials

Showell,

Cole,

Clarke

et al. 2024

Cochrane Database of Systematic Reviews

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Discontinuation and nonpublication of clinical trials in orthopaedic oncology

Singh,

Wague,

Arora

et al. 2024

J Orthop Surg Res

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Background Despite the pivotal role of clinical trials in advancing orthopaedic oncology knowledge and treatment strategies, the persistent issues of trial discontinuation and nonpublication are significant problems. This study conducted an analysis examining clinical trial discontinuation rates, associations between intervention types and discontinuation/nonpublication, and the role of funding, enrollment size, and their implications for trial success and completion. Methods This study, conducted on May 1, 2023, utilized a cross-sectional design to comprehensively analyze phase 3 and 4 randomized controlled trials within the realm of orthopaedic oncology. We specifically incorporated Phase 3 and 4 trials as they are designed to evaluate prolonged outcomes in human subjects and are more likely to reach publication. Study characteristics of interest included the intervention utilized in the clinical trial, presence of funding, whether the trial was published, completed, and trial enrollment size. The investigation involved an examination of ClinicalTrials.gov, a prominent online repository of clinical trial data managed by the National Library of Medicine of the USA. Descriptive statistics and multivariate logistic regressions were used to determine statistical significance. Results Among the cohort of 130 trials, 19.2% were prematurely discontinued. Completion rates varied based on intervention type; 111 pharmaceutical trials demonstrated a completion rate of 83.8%, whereas 19 non-pharmaceutical trials exhibited a completion rate of 8.0% (P < .001). Surgical trials, totaling 10, showed a completion rate of 90%. The overall trial publication rate was 86.15%, with pharmaceutical interventions achieving a publication rate of 91.96%. Larger-scale trials (≥ 261 participants) emerged as a protective factor against both discontinuation (Adjusted Odds Ratio [AOR]: 0.85, 95% Confidence Interval [CI] 0.42–0.95) and nonpublication (AOR: 0.19, 95% CI 0.13–.47), compared to smaller-scale trials. Conclusion This study accentuates the heightened vulnerability of non-pharmaceutical interventions and trials exhibiting lower rates of enrollment to the issues of discontinuation and nonpublication. Moving forward, the advancement of clinical trials necessitates a concerted effort to enhance trial methodologies, especially concerning nonpharmaceutical interventions, along with a meticulous refinement of participant enrollment criteria.

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Discontinuation and non-publication rates of U.S. clinical trials for the pharmacologic treatment of type 2 diabetes mellitus: A cross-sectional analysis

Cited by 3 publications

References 6 publications

Discontinuation and Nonpublication of Clinical Trials in Orthopaedic Oncology

Discontinuation and Nonpublication of Clinical Trials in Orthopaedic Oncology

Time to publication for results of clinical trials

Discontinuation and nonpublication of clinical trials in orthopaedic oncology

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