An observational analysis of discontinuation and non-publication of osteoarthritis trials

Scott, Jared; Cooper, Craig; Checketts, Jake X.; Cutler, J.; Boose, Marshall; Morris, Jeffrey S.; Vassar, Matt

doi:10.1016/j.joca.2018.05.019

Cited by 19 publications

(27 citation statements)

References 25 publications

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“…Although we used multiple search methods, we were unable to find email contacts for twothirds of 63 unpublished trials included in our study. Consistent with our findings, Scott et al 21 had similar difficulties when attempting to locate contact information of the investigators, only finding 39.4% of email addresses. 20 Up-to-date monitoring of trial status on trial registries and ensuring that each trial publication and principal investigator's contact information are linked to the registry might alleviate some difficulties in accessing data from published and nonpublished RCTs.…”

Section: Discussionsupporting

confidence: 92%

“…These results merit further research to define contributing factors because they are not consistent with previous works in other medical specialties. For example, a 2018 orthopedic study 21 found reasons for trial discontinuation for 29 of 30 (97%) discontinued trials related to osteoarthritis. Moreover, all 273 osteoarthritis RCTs (97%) reported the reasoning for trial discontinuation on ClinicalTrials.gov.…”

Section: Discussionmentioning

confidence: 99%

“…We excluded phase 1 and 2 trials because these are typically performed for safety and precautionary purposes and publication is less likely. The exclusion date of March 1, 2016, was chosen to allow the investigators 36 months from the date of trial completion for publication . Because HNC can occur in any patient population, no limitation was enforced for patient age or demographics.…”

Section: Methodsmentioning

confidence: 99%

“…The exclusion date of March 1, 2016, was chosen to allow the investigators 36 months from the date of trial completion for publication. 21,22 Because HNC can occur in any patient population, no limitation was enforced for patient age or demographics.…”

Section: Key Pointsmentioning

confidence: 99%

“…This method of email contact to obtain information about relevant trials has been deployed with success in similar studies. 21,22 If both the search process and email contact did not provide evidence of publication, we considered the trial to be unpublished.…”

Section: Contacting Authors When No Publication Could Be Locatedmentioning

confidence: 99%

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Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials

Johnson

Fladie

Anderson

et al. 2020

JAMA Otolaryngol Head Neck Surg

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IMPORTANCE Randomized clinical trials (RCTs) play an important role in clinical decision-making, and discontinuation or nonpublication of these trials are causes of great concern. The extent of discontinued or unpublished RCTs about head and neck cancer remains unclear. OBJECTIVE To assess the rate of discontinuation or nonpublication of RCTs involving patients with head and neck cancer. This objective was measured by observing 3 domains: discontinuation of trial, nonpublication of trial data, and feasibility of contacting trial investigators of aforementioned trials. EVIDENCE REVIEW For this study, the sample was derived using the ClinicalTrials.gov advanced search feature on March 18, 2019, to locate completed and discontinued RCTs pertaining to head and neck cancer registered before this date. Trials were analyzed to identify reasons for trial discontinuation and publication status of each trial. If publication status or reason for trial discontinuation was not allocated through the systematic search of ClinicalTrials.gov, the corresponding author was emailed to determine publication status. FINDINGS After exclusions, 130 RCTs were included. Of these trials, 92 (70.8%) were completed and 38 (29.2%) were discontinued for various reasons. The most common reason for discontinuation of trials was committee recommendations. Of the 130 analyzed trials, 67 (51.5%) were published in a peer-reviewed journal and 63 (48.5%) were unpublished trials. Of the 92 completed trials, 55 (59.8%) were published and 37 (40.2%) remained unpublished 3 or more years after trial completion. Trials funded by other sources (private, nonprofit, or the National Institutes of Health) were more likely to reach publication than industry-funded RCTs (unadjusted odds ratio, 4.3 [95% CI, 1.3-14.0]; adjusted odds ratio, 4.1 [95% CI, 1.2-14.3]). CONCLUSIONS AND RELEVANCE Of RCTs in head and neck cancer, 29.2% were discontinued and 40.2% completed trials never reached publication. The findings suggest that needs exist for RCT guidance of head and neck cancer. The reporting of reasons for trial discontinuation appears to be lacking, and trial publication rates were low. This study is relevant to many physicians and researchers because it identifies potential sources of decreased research productivity and ethics.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Key Pointsmentioning

confidence: 99%

Section: Contacting Authors When No Publication Could Be Locatedmentioning

confidence: 99%

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Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials

Johnson

Fladie

Anderson

et al. 2020

JAMA Otolaryngol Head Neck Surg

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Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study

Brigante

Russo

Mongin

et al. 2022

Arthritis Care & Research

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Objectives. To assess the proportion, the reasons, and the factors associated with discontinuation or nonpublication of randomized controlled trials (RCTs) on connective tissue diseases (CTDs). Methods.We searched all interventional RCTs on CTDs registered in Clinicaltrials.gov since 2000. Two reviewers selected studies according to pre-specified eligibility criteria. Completion status, publication status, reported reasons for discontinuation or nonpublication, were retrieved on Clinicaltrials.gov, through literature search, and by contacting investigators. Multivariable logistic regression was used to identify factors associated with study noncompletion and nonpublication.Results. We included 175 studies, mostly phase 3, placebo-controlled trials on pharmacologic treatments, recruiting patients with systemic lupus (51%), systemic sclerosis (20%), Sjögren syndrome (12%) or other CTDs. Fifty-eight (33%) had been discontinued, mainly for insufficient patient accrual, with no differences in discontinuation rates across the CTDs (P>0.5). Forty-six (35%) of 130 studies having included at least 1 patient resulted unpublished, and 86 (65%) were published in a peer-reviewed journal after a median of 24 months (IQ 15-41) from completion, with a significant higher publication rate in completed vs. discontinued studies (81% vs 22%; P<0.001). We were able to obtain reasons for nonpublication in one-third of cases.Small sample size (< 100 participants) was the only factor associated with study noncompletion and nonpublication.Conclusions. One of three registered CTD-RCTs fails to be completed or published. This represents a waste of resources and raises ethical concerns regarding hidden clinical data and unfruitful participation by patients. Significance and innovation Trial discontinuation and nonpublication represent a waste of resources and raise ethical concerns regarding hidden clinical data and unfruitful participation by patients. One of three CTD-RCTs registered after 2000 failed to be completed or published, with similar rates recorded across CTDs.

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Discontinuation and nonpublication of clinical trials for the pharmacologic treatment of posttraumatic stress disorder among military veterans

Weygandt

Moody

Sajjadi

et al. 2023

Journal of Traumatic Stress

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Failures by researchers and clinicians to overcome barriers in veteran healthrelated research may result in clinical trial (CT) discontinuation and nonpublication. Such outcomes are a waste of limited academic resources. To determine rates of discontinuation and nonpublication among CTs for posttraumatic stress disorder (PTSD) with pharmaceutical interventions specific to the veteran population, we performed a systematic search of registered trials in ClinicalTrials.gov for pharmaceutical interventions for the treatment of PTSD. Extracted study characteristics included sample size, study design, trial status, phase, and funding source. Studies were classified as completed or discontinued based on the status listed in ClinicalTrials.gov. Descriptive statistics of trials were reported,and associations of trial termination and nonpublication were assessed using logistic regression. The final sample included 54 CTs, 15 of which (27.8%) had not been published within the FDA's required timeframe, and 11 (20.4%) were discontinued. The total number of trial participants was 3,463, with a median of 37 (interquartile range: 15-92). Of the 54 trials, 12 (22.2%) were nonrandomized, and 42 (77.8%) were randomized. There were 25 (46.3%) trials that were in either Phase 3 or Phase 4, and 39 (72.2%) were government-funded. We found high rates of CT discontinuation and nonpublication among PTSD pharmaceutical intervention studies in veterans, as has been shown in other fields of research.

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An observational analysis of discontinuation and non-publication of osteoarthritis trials

Cited by 19 publications

References 25 publications

Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials

Rates of Discontinuation and Nonpublication of Head and Neck Cancer Randomized Clinical Trials

Extent of and Reasons for Discontinuation and Nonpublication of Interventional Trials on Connective Tissue Diseases: An Observational Study

Discontinuation and nonpublication of clinical trials for the pharmacologic treatment of posttraumatic stress disorder among military veterans

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