Discontinuation and nonpublication of interventional clinical trials conducted in ophthalmology

Yilmaz, Taygan; Gallagher, Michéal J.; Cordero‐Coma, Miguel; Gealy, Daniel; Loporchio, Salvatore J.; Padula, William V.; Loporchio, Dean; Statler, Brittney; Migliori, Michael E.

doi:10.1016/j.jcjo.2019.06.007

Cited by 2 publications

(6 citation statements)

References 9 publications

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“…Additionally, we found that 7% of discontinued studies were stopped due to futility. When a trial is projected to have inconclusive or negative results, investigators may decide to discontinue the study and not report the results on trial registries or in a research journal, but this practice introduces bias into the literature 4,30,31 . All research contributes to the medical knowledge landscape, even those studies with inconclusive or negative results.…”

Section: Discussionmentioning

confidence: 99%

“…Clinical trials represent rigorous scientific research that requires substantial investments of resources. The results of these trials are frequently used to revise clinical guidelines and to enhance patient-care standards [1][2][3][4] . Therefore, limiting the number of discontinued clinical trials is crucial 5,6 .…”

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confidence: 99%

“…For example, discontinued trials introduce publication bias, which leads to an incomplete picture of the research landscape 7 . Additionally, limiting waste in clinical trials would provide a greater body of evidence for clinicians to reference when evaluating treatment options, prevent misrepresentations of the safety and efficacy of interventions, mitigate unnecessary patient exposures, and encourage patient participation in trials 1,[4][5][6] .…”

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confidence: 99%

“…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%

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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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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

See 2 more Smart Citations

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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“…10,11 Previous research on OCTs characterized publication rates, geographic disparities, and design characteristics. [12][13][14] The effects of the COVID-19 pandemic on OCT discontinuation are unclear. A greater understanding of trials discontinued due to the pandemic may aid the design and management of future trials, leading to reduced resource waste.…”

Section: Introductionmentioning

confidence: 99%

The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov

Kakkilaya,

Hooda,

Kalva

et al. 2023

SAGE Open Medicine

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Objective: To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials. Methods: On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were “recruiting,” “active, not recruiting,” “enrolling by invitation,” “suspended,” “terminated,” “completed,” or “withdrawn” and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I–IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons. Results: Following the screening, 2280/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26/34, 76.5% vs 57/108, 52.8%, p = 0.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22/34, 64.7% vs 46/108 42.6%, p = 0.003). Conclusions: COVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials.

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Discontinuation and nonpublication of interventional clinical trials conducted in ophthalmology

Cited by 2 publications

References 9 publications

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery

What Factors Are Associated with Clinical Trial Discontinuation in Orthopaedic Surgery

The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov

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