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40
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Hyperlink
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URL
https://doi.org/10.1007/s00403-022-02449-6
Dublin Core
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Title
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Evaluating publication bias for clinical trials supporting new dermatologic drug approvals from 2003 to 2018
Creator
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Sairekha Ravichandran
Kathleen M Mulligan
Harib H Ezaldein
Jeffrey F Scott
Date
A point or period of time associated with an event in the lifecycle of the resource
2022
Description
An account of the resource
The degree of publication bias and impact of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which aimed to improve clinical trial transparency, has yet to be examined for recent dermatologic drugs. The objective of our study was to estimate the degree of publication bias for clinical trials supporting FDA approval of new dermatologic drugs. This retrospective cohort study examined all phase II and III efficacy trials supporting approval of new dermatologic drugs from 2003 to 2018. FDA drug approval documents were reviewed for supportive clinical trial information, and publications were matched using PubMed and Google Scholar searches. Ratios of relative risks (RRR) comparing positive versus non-positive trials before and after FDAAA enactment served to estimate publication bias. We found that the likelihood of publishing positive versus non-positive drug trials in dermatology was unchanged before and after FDAAA enactment (RRR 0.87, 95% CI 0.37-2.08), as was the likelihood of publishing without misleading interpretation (RRR 1.51, 95% CI 0.22-10.50). There was no measurable publication bias for efficacy trials supporting new drug approvals in dermatology over the past 15 years. Fewer pre-FDAAA trials (n = 21) compared to post-FDAAA trials (n = 106) met inclusion criteria. Though not analyzed in this study, safety and secondary efficacy results are other potential sources for publication bias.
Source
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Arch Dermatol Res
. 2022 Nov 4. doi: 10.1007/s00403-022-02449-6. Online ahead of print.
Language
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English
2022
Clinical Trials
Dermatologic drugs
Negative reporting
Publication Bias
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Text
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URL Address
<a href="http://doi.org/10.1186/s12885-015-1834-4" target="_blank" rel="noreferrer noopener">http://doi.org/10.1186/s12885-015-1834-4</a>
Pages
815–815
Volume
15
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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The importance of extranodal extension in penile cancer: a meta-analysis.
Publisher
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BMC cancer
Date
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2015
2015-10
Subject
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Comparative Studies; Cox Proportional Hazards Model; Evaluation Research; Human; Humans; Lymph Nodes – Pathology; Lymph Nodes/pathology; Lymphatic Metastasis; Male; Meta Analysis; Multicenter Studies; Neoplasm Metastasis; Odds Ratio; Penile Neoplasms – Diagnosis; Penile Neoplasms – Mortality; Penile Neoplasms – Pathology; Penile Neoplasms/diagnosis/*mortality/*pathology; Prognosis; Proportional Hazards Models; Publication Bias; Validation Studies
Creator
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Zhang Zhi-Ling; Yu Chun-Ping; Liu Zhuo-Wei; Velet Liliya; Li Yong-Hong; Jiang Li-Juan; Zhou Fang-Jian
Description
An account of the resource
BACKGROUND: The role of extranodal extension (ENE) in penile cancer is controversial and has not been well studied. The aim of this study was to investigate the importance of ENE in predicting prognosis and presence of pelvic lymph node metastasis (PLNM) in penile cancer patients. METHODS: We searched related studies in Medline, Embase, Cochrane Library, and Scopus database. Hazard ratio (HR) and odds ratio (OR) were directly extracted or indirectly estimated from the included studies. RESULTS: A total of ten studies with 1,142 patients were included in this meta-analysis. Patients with ENE showed a worse cancer-specific survival (CSS) (HR = 1.90, 95 % confidence interval [CI] = 1.35-2.67, P = 0.0002) and overall survival (HR = 4.04, 95 % CI = 1.02-16.1, P = 0.05) than those without ENE. Further subgroup analysis revealed that the predictive value of ENE for CSS in penile cancer patients was significant regardless of the study's country of origin, but not in the subgroup with shorter follow-up time (\textless36 months, P = 0.38). Patients with ENE also showed a higher incidence of presenting with PLNM (OR = 4.95, 95 % CI = 2.58-9.49, P \textless 0.001). A stratified analysis demonstrated that the predictive role of ENE for PLNM was only detected in studies with a larger sample size (\textgreater 100 cases). No significant publication bias was observed, as suggested by Begg's and Egger's tests. CONCLUSIONS: ENE is associated with worse prognosis and high risk of PLNM in penile cancer patients. Due to the limited number of studies included in this meta-analysis, a large-scale, well-designed study will be required to verify our results.
Identifier
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<a href="http://doi.org/10.1186/s12885-015-1834-4" target="_blank" rel="noreferrer noopener">10.1186/s12885-015-1834-4</a>
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2015
BMC cancer
Comparative Studies
Cox Proportional Hazards Model
Evaluation Research
Human
Humans
Jiang Li-Juan
Li Yong-Hong
Liu Zhuo-Wei
Lymph Nodes – Pathology
Lymph Nodes/pathology
Lymphatic Metastasis
Male
Meta Analysis
Multicenter Studies
Neoplasm Metastasis
Odds Ratio
Penile Neoplasms – Diagnosis
Penile Neoplasms – Mortality
Penile Neoplasms – Pathology
Penile Neoplasms/diagnosis/*mortality/*pathology
Prognosis
Proportional Hazards Models
Publication Bias
Validation Studies
Velet Liliya
Yu Chun-Ping
Zhang Zhi-Ling
Zhou Fang-Jian
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1371/journal.pone.0149420" target="_blank" rel="noreferrer noopener">http://doi.org/10.1371/journal.pone.0149420</a>
Pages
e0149420–e0149420
Issue
2
Volume
11
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
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The Difference in Prognosis between Renal Sinus Fat and Perinephric Fat Invasion for pT3a Renal Cell Carcinoma: A Meta-Analysis.
Publisher
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PloS one
Date
A point or period of time associated with an event in the lifecycle of the resource
2016
1905-07
Subject
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Female; Humans; Male; Neoplasm Staging; Odds Ratio; Prognosis; Neoplasm Invasiveness; Proportional Hazards Models; Intra-Abdominal Fat/*pathology; Kidney Neoplasms/*mortality/*pathology; Publication Bias; Carcinoma; Renal Cell/*mortality/*pathology
Creator
An entity primarily responsible for making the resource
Zhang Zhi-Ling; Yu Chun-Ping; Velet Liliya; Li Yong-Hong; Jiang Li-Juan; Zhou Fang-Jian
Description
An account of the resource
BACKGROUND: In the current Tumour-Node-Metastasis (TNM) classification system for renal cell carcinoma (RCC), both renal sinus fat invasion (SFI) and perinephric fat invasion (PFI) are defined as T3a, suggesting that the prognosis should be similar for the two pathologic findings. Several studies, however, have reported a worse prognosis for SFI in patients with a T3a tumor. In order to compare the prognosis of these two pathologic findings (SFI versus. PFI) in a more comprehensive way, this meta-analysis was performed. METHODS: To identify relevant studies, Medline, Embase, Cochrane Library, and Scopus database were searched from the inception until October 2014. A meta-analysis was performed using Review Manager 5.2 and STATA 11. Pooled Odds ratio (OR) and/or hazard ratio (HR) with 95% confidence interval (CI) were calculated to examine the risk or hazard association. RESULTS: A total of 6 studies including 1031 patients qualified for analysis. T3a RCC patients with SFI were significantly associated with poor cancer specific survival(CSS) (HR: 1.47, 95% CI: 1.19-1.83; P\textless0.001) compared to those with PFI. In T3aNx/N0M0 subgroup, SFI patients also showed a worse prognosis than those with PFI (CSS, HR: 1.94, 95% CI: 1.21-3.12; P = 0.006). T3a RCC patients with SFI had higher Furhman grade, greater possibility of lymph node metastasis, sarcomatoid differentiation and tumour necrosis. Main limitation is the relatively small number of included studies. CONCLUSION: The present meta-analysis suggested that SFI is associated with worse CSS in patients with pT3a RCC. However, due to the small number of included studies, future studies with a large sample size are required to further verify our findings.
Identifier
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<a href="http://doi.org/10.1371/journal.pone.0149420" target="_blank" rel="noreferrer noopener">10.1371/journal.pone.0149420</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2016
Carcinoma
Female
Humans
Intra-Abdominal Fat/*pathology
Jiang Li-Juan
Kidney Neoplasms/*mortality/*pathology
Li Yong-Hong
Male
Neoplasm Invasiveness
Neoplasm Staging
Odds Ratio
PloS one
Prognosis
Proportional Hazards Models
Publication Bias
Renal Cell/*mortality/*pathology
Velet Liliya
Yu Chun-Ping
Zhang Zhi-Ling
Zhou Fang-Jian