Burn clinical trials: A systematic review of registration and publications

Sinha, Sarthak; Yoon, Grace; Shin, Wisoo; Biernaskie, Jeff; Nickerson, Duncan; Gabriel, Vincent

doi:10.1016/j.burns.2017.11.001

Cited by 7 publications

(6 citation statements)

References 21 publications

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“…Next, we investigated whether funding impacted PRS CT publication and discontinuation, given past findings of discrepant publication rates between industry and academic-funded CTs. 14,35–37 We found that industry-funded CTs have lower publication rates (18% completed, 6% terminated) compared with their academic-funded counterparts (27% completed, 12% terminated).…”

Section: Resultsmentioning

confidence: 74%

“…4E), aligning with prior work. 14,25,30,38,39 Uniquely, 13.1% of CTs ended due to “sponsor’s decision to terminate.” These included “company acquisition,” “strategic business decisions,” determination that CT was no longer in sponsor’s interest, changes in business objectives, and decision to no longer pursue the product. COVID-19 accounted for 3.6% of terminations.…”

Section: Resultsmentioning

confidence: 99%

“…12 Third is nonpublication or protracted publication of completed CTs. [13][14][15] Fourth, publication of skewed evidence is prevalent; CTs tend to selectively report outcomes, overemphasize benefits, and downplay risks. 16 Lastly, a geographical disparity exists: high-income countries conduct more CTs than their low-and middleincome counterparts due to systemic, organizational, and individual barriers in low-and middle-income countries.…”

Section: Introductionmentioning

confidence: 99%

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Plastic Surgery Clinical Trials: A Systematic Review of Characteristics, Research Themes, and Predictors of Publication and Discontinuation

Sinha,

Arora,

Chockalingam

et al. 2023

Plastic and Reconstructive Surgery - Global Open

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Summary: Clinical trials (CTs) are crucial for evidence-based surgical care. Despite growing interest in plastic and reconstructive surgery (PRS) research, the status of PRS CTs remains unknown. We obtained PRS CTs from ClinicalTrials.gov and WHO’s International Clinical Trials Registry Platform (November 2022). Topic modeling identified research themes and machine learning models generated CT-publication pairs. Kaplan-Meier curves visualized CT discontinuation and nonpublication. Of the 4685 PRS CTs identified, 79% were interventional and 81% recruited adults. Most were single-center-led (67%) and academic-funded (77%). Male investigators led 77% of CTs. Female-only patient CTs outnumbered male-only (31% versus 1%). The United States led with 41% of CTs, followed by France, Canada, and China. Industry-funded CTs were higher in the USA, Germany, and Belgium, and academic-funded in France, Canada, and China. PRS CTs clustered into aesthetics (43%), reconstructive (20%), wound healing (8%), peripheral nerve (6%), tumor excision (5%), craniofacial (5%), perioperative pain (5%), and burns (4%). Industry preferred funding aesthetics, whereas academia and industry co-funded wound healing. Publication rates of completed (24%) and terminated (10%) CTs varied by cluster, with perioperative pain CTs exhibiting higher rates. Industry-funded CTs had lower publication rates (hazard ratio: 0.64, 95% confidence interval: 0.5–0.81) and higher discontinuation (hazard ratio: 1.34, confidence interval: 1.06–1.68) driven by sponsors’ decision to terminate prematurely. Global growth in PRS trialome reflects rising interest in evidence-based plastic surgery. Yet, imbalances in participant age, geography, funding source, and trial design influence likelihood of CT discontinuation and publication. Key research gaps include pediatric CTs, accountability in industry-funded research, and multicenter collaborations with underrepresented regions.

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Section: Resultsmentioning

confidence: 74%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Plastic Surgery Clinical Trials: A Systematic Review of Characteristics, Research Themes, and Predictors of Publication and Discontinuation

Sinha,

Arora,

Chockalingam

et al. 2023

Plastic and Reconstructive Surgery - Global Open

Self Cite

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“…[10] . Lack of funds is one of the major setbacks in implementation of clinical trials [11] . Countries should therefore strive to support rectal cancer research by allocating funds to it.…”

Section: Discussionmentioning

confidence: 99%

Registration of Rectal Cancer-Related Clinical Trials on Chinese Clinical Trial Registry over past decades

Zhou

Zhang

et al. 2020

Preprint

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Background This study investigated and analyzed rectal cancer-related clinical trials registered on Chinese Clinical Trial Registry (Chi-CTR) by the end of 2018. We aimed to discuss the characteristics and developmental trends. Methods The Chi-CTR database was searched and all clinical trials related to rectal cancer extracted. The time limit for the search was from the establishment of the data library to December 31, 2018. The characteristics of registered clinical trials were then analyzed. Results A total of 70 clinical trials were retreived. Beijing, Shandong, and Guangzhou accounted for 47.1% of the total number of registered clinical trials. Sichuan and Sun Yat-sen Universities having the highest number of registrations. The registration status of the 55 trials was prospective registration. The top sources of funding were self-financing (41.4%), hospital funding (22.9%) and local finance (15.7%). Out of the 43 randomized controlled trials, 39 were either blank or missing in the blinded section. The sample size of clinical trials was high in 100 to 199 cases. Only eight of the 70 trials were multicenter clinical trials. Conclusions Relevant departments should increase the registration of clinical trials, increase the awareness of registration, and promote the development of high-quality clinical trials. At the same time, researchers should raise the awareness of clinical trial registration, and actively carry out multi-center clinical trials.

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“…However, trial quality and adherence to reporting standards are uncertain 10–13. Previous studies are limited by their lack of comprehensiveness and methods of quality assessment 14–16. Quality assessment of RCTs involves evaluating internal and external validity.…”

Section: Introductionmentioning

confidence: 99%

Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review

et al. 2019

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IntroductionBurn care represents a healthcare and economic burden to patients internationally. Choice of the most clinically effective treatment strategies requires evidence which is best obtained through high-quality randomised controlled trials (RCT). The number of published RCTs of burn care is increasing. However, trial quality and reporting standards are unclear. This study will assess the risk of bias and adequacy of reporting in recent burn care RCTs using tools endorsed by the Cochrane Collaboration.Methods and analysisA systematic literature review will be undertaken, assessing parallel group RCTs evaluating therapeutic interventions for patients with cutaneous burns. Literature searches will use Ovid Medline, Ovid Embase, Web of Science and the Cochrane Library. Separate searches for each database will include medical subject heading and free text terms including ‘burn’, ‘scald’, ‘thermal injury’ and ‘RCT’. Two reviewers will independently assess each study for inclusion. Risk of bias (RoB) will be assessed with the revised tool (RoB 2) and reporting completeness with the CONsolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. We will report a narrative synthesis of all studies, including domain specific, and overall risk of bias for the primary outcome of each trial. Inter-rater agreement for RoB 2 will be reported using Fleiss’s Kappa. For adherence to the CONSORT guidelines, we will generate a completeness of reporting index for the ﬁve domains.Ethics and disseminationNo ethics approval is required because published documents will be used. Findings of the study will be disseminated in a peer-reviewed journal and presented at conferences.PROSPERO registration numberCRD42018111020.

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Burn clinical trials: A systematic review of registration and publications

Cited by 7 publications

References 21 publications

Plastic Surgery Clinical Trials: A Systematic Review of Characteristics, Research Themes, and Predictors of Publication and Discontinuation

Plastic Surgery Clinical Trials: A Systematic Review of Characteristics, Research Themes, and Predictors of Publication and Discontinuation

Registration of Rectal Cancer-Related Clinical Trials on Chinese Clinical Trial Registry over past decades

Risk of bias and reporting completeness of randomised controlled trials in burn care: protocol for a systematic review

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