Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

Koucheki, Robert; Gazendam, Aaron; Perera, Jonathan R; Griffin, Anthony M.; Ferguson, Peter C.; Wunder, Jay S.; Tsoi, Kim

doi:10.3390/curroncol28050322

Cited by 6 publications

(6 citation statements)

References 107 publications

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“…Many meta-analyses have been conducted on a wide array of topics. In the medical specialty of oncology, many of these meta-analyses have focused on treatment efficacy of drugs or bias in interventional studies on a specific topic . To our knowledge, there have been no scoping analyses evaluating the general characteristics of meta-analyses in oncology journals and factors associated with bias.…”

Section: Introductionsupporting

confidence: 89%

Scoping Review of Published Oncology Meta-analyses in High-Impact Oncology Journals

2023

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ImportanceMany meta-analyses have been conducted on a wide array of topics, and many of these have focused on treatment efficacy of drugs or bias in interventional studies on a specific topic.ObjectiveTo examine the factors associated with having a positive study conclusion in meta-analyses in the field of oncology.Evidence ReviewAll meta-analyses published between January 1, 2018, and December 31, 2021, on 5 oncology journal websites were identified and study characteristics, study results, and information on study authors were abstracted. The meta-analysis authors’ conclusions were coded as positive, negative, or equivocal, and each article subject matter was coded as one that could affect profits and marketing of a company. Whether an association existed between study characteristics and authors’ conclusions was also examined.FindingsDatabase searches resulted in 3947 potential articles, of which 93 meta-analyses were included in this study. Of the 21 studies with author funding from industry, 17 studies (81.0%) reported favorable conclusions. Of the 9 studies that received industry funding, 7 (77.8%) reported favorable conclusions, and of the 63 studies that did not have author or study funding from industry, 30 (47.6%) reported favorable conclusions. Studies that were funded through nonindustry sources and authors who had no relevant conflict of interest had the lowest percentage of positive conclusions and the highest percentage of negative and equivocal conclusions compared with studies with other sources of potential conflict of interest.Conclusions and RelevanceIn this cross-sectional study of meta-analyses published in oncology journals, multiple factors were associated with having a positive study conclusion, which suggests that future research should be performed to elucidate reasons for more favorable conclusions among studies with study or author industry funding.

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Section: Introductionsupporting

confidence: 89%

Scoping Review of Published Oncology Meta-analyses in High-Impact Oncology Journals

2023

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“…During the covid-19 pandemic, these clinical trials were primarily and rapidly designed to evaluate efficacy, possibly explaining why some clinical trials had a low or very low quality of adverse event reporting. Based on the results of our systematic review comparing the reporting of harms of several covid-19 drugs, and results from previous studies, 64 adverse event reporting seemed to be more complete in clinical trial summaries than in journal articles.…”

Section: Discussionmentioning

confidence: 80%

“…In a study of osteosarcoma and Ewing's sarcoma, the prevalence of a low risk bias was 47.3%, unclear risk domains was 47.8%, and 4.9% of domains had a high risk of bias in randomised clinical trials. 64 Domains with the highest risk of bias were blinding of participants or staff, and outcome assessors, followed by randomisation and allocation concealment. In our study, risk of bias was mainly high in 92.9% of the included clinical trials.…”

Section: Discussionmentioning

confidence: 99%

Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review

Madi,

Flumian,

Olivier

et al. 2023

bmjmed

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ObjectiveTo assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published on PubMed versus clinical trial summaries on ClinicalTrials.gov.DesignSystematic review.Data sourcesPubMed and ClinicalTrials.gov registries were searched from 1 December 2019 to 17 February 2022.Eligibility criteria for selecting studiesRandomised clinical trials evaluating the efficacy and safety of drugs used to treat covid-19 disease in participants of all ages with suspected, probable, or confirmed SARS-CoV-2 infection were included. Clinical trials were screened on title, abstract, and text by two authors independently. Only articles published in French and English were selected. The Cochrane risk of bias tool for randomised trials (RoB 2) was used to assess risk of bias.ResultsThe search strategy identified 1962 randomised clinical trials assessing the efficacy and safety of drugs used to treat covid-19, published in the PubMed database; 1906 articles were excluded after screening and 56 clinical trials were included in the review. Among the 56 clinical trials, no study had a high score for quality of reporting of adverse events, 60.7% had a moderate score, 33.9% had a low score, and 5.4% had a very low score. All clinical trials with a very low score for quality of reporting of adverse events were randomised open label trials. For reporting of serious adverse events, journal articles published on PubMed under-reported 51% of serious adverse events compared with clinical trial summaries published on ClinicalTrials.gov.ConclusionsIn one in three published clinical trials on covid-19 drugs, the quality of reporting of adverse events was low or very low. Differences were found in the number of serious adverse events reported in journal articles versus clinical trial summaries. During the covid-19 pandemic, risk assessment of drugs in clinical trials of covid-19 drugs did not comply with good practice recommendations for publication of results.Systematic review registrationEuropean Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) EUPAS45959.

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“…This is unsurprising given that industry funding has been associated with positive results in studies from a variety of medical fields [11, 12, 17, 19, 20, 22]. Due to the potential for bias, it is imperative that funding sources and financial CoI be declared so that they can be taken into account when interpreting study results [18].…”

Section: Discussionmentioning

confidence: 99%

Failure to disclose industry funding impacts outcomes in randomized controlled trials of platelet-rich plasma

Chou

Gazendam

Vemulakonda

et al. 2022

Knee Surg Sports Traumatol Arthrosc

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Purpose Platelet-rich plasma (PRP) represents a highly proitable biological therapy. Platelet-rich plasma is widely used to treat musculoskeletal disorders despite mixed evidence of its eicacy. As evidenced by literature from other domains, industry funding may inluence the results of clinical trials. The objective of the current study was to determine the association between industry funding and positive results for randomized controlled trials (RCTs) assessing the eicacy of PRP in musculoskeletal disorders. Methods A search of four databases was conducted. Included studies were RCTs comparing PRP to any non-PRP comparator in adults (18 years old or over) with musculoskeletal disorders and had full text available in English. Studies were excluded if they were published before 2016 or were non-human trials. A multivariate binomial logistic regression model was created to explore predictors of statistically signiicant indings. Covariates included the presence of industry funding, sample size, and length of study follow-up. 1440 records were screened with 87 trials included in the inal analysis. Results Of the 87 studies, 61 (70%) reported a statistically signiicant primary outcome. The presence of industry funding was not predictive of a statistically signiicant primary outcome [OR = 0.36, 95% CI 0.096-1.36, (n.s.)]. Studies that did not state whether industry funding was present had a higher chance of reporting a statistically signiicant primary outcome (OR = 3.61, 95% CI 1.1-11.9, p = 0.035). Sample size and length of follow-up were not predictive of a statistically signiicant primary outcome. ConclusionThe results of the current study conclude that industry funding had no impact on the reporting of positive results for RCTs investigating PRP in musculoskeletal disorders. However, not disclosing sources of funding was associated with a higher likelihood of reporting positive results. The results of trials that fail to disclose funding sources should be interpreted with caution in the PRP literature. Level of evidence I.

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Assessment of Risk of Bias in Osteosarcoma and Ewing’s Sarcoma Randomized Controlled Trials: A Systematic Review

Cited by 6 publications

References 107 publications

Scoping Review of Published Oncology Meta-analyses in High-Impact Oncology Journals

Scoping Review of Published Oncology Meta-analyses in High-Impact Oncology Journals

Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review

Failure to disclose industry funding impacts outcomes in randomized controlled trials of platelet-rich plasma

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