scholarly journals Maintaining Integrity of Worldwide FINGER Clinical Trials During the COVID-19 Pandemic

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 68-68
Author(s):  
Susanne Roehr
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
World Wide ◽  
Randomized Clinical Trials ◽  
Statistical Design ◽  
Sensitivity Analyses ◽  
Intervention Delivery ◽  
Intention To Treat ◽  
Approaches To Study ◽  
Intervention Trials

Abstract The COVID-19 pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions. World-Wide FINGERS international network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic. We report experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues. We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials. The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessments protocols. The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within site stratification, interim power projections, and sensitivity analyses. Robust approaches to study design and analysis are critical to negotiate issues related to the intervention.

Cost-effectiveness analysis of neoadjuvant immune checkpoint inhibition (ICI) versus cisplatin-based chemotherapy (CBC) in muscle-invasive bladder cancer (MIBC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 419-419
Author(s):  
Ali Raza Khaki ◽  
Yong Shan ◽  
Richard Nelson ◽  
Sapna Kaul ◽  
John L. Gore ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Randomized Clinical Trials ◽  
Pathologic Complete Response ◽  
Weighted Average ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Sensitivity Analyses ◽  
Effectiveness Analysis

419 Background: Multiple single-arm clinical trials have shown promising pathologic complete response (pCR) rates with neoadjuvant ICIs in MIBC. However, ICIs remain costly. We conducted a cost-effectiveness analysis comparing neoadjuvant ICIs with CBC. Methods: We applied a decision analytic simulation model with a health care payer perspective and two-year time horizon to compare neoadjuvant ICIs vs CBC. For the primary analysis we compared pembrolizumab with dose dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC). We performed a secondary analysis with gemcitabine/cisplatin (GC) as CBC and exploratory analyses with atezolizumab or nivolumab/ipilimumab as ICIs (vs both ddMVAC and GC). We input pCR rates from trials (ICIs) or a weighted average of prior studies (CBC) and costs from average sales price. Outcomes of interest included costs, 2-year recurrence-free survival (RFS), and incremental cost-effectiveness ratio (ICER) of cost per 2-year RFS. A threshold analysis estimated a pCR rate or price reduction for ICI to be cost-effective and one-way and probabilistic sensitivity analyses were performed. Results: Results of the cost effectiveness analysis are shown in the table. The incremental cost of pembrolizumab compared with ddMVAC was $8,042 resulting in an incremental improvement of 0.66% in 2-year RFS for an ICER of $1,218,485 per 2-year RFS. A pCR of 71% or a 26% reduction in cost of pembrolizumab would render it more cost-effective with an ICER of $100,000 per 2-year RFS. GC required a 96% pembrolizumab cost reduction to achieve an ICER of $100,000 per 2-year RFS. Atezolizumab appeared to be more cost-effective than ddMVAC, even though the 2yr RFS was 0.66% worse. Conclusions: ICIs were not cost-effective as neoadjuvant therapies, except when atezolizumab was compared with ddMVAC. Pembrolizumab would approach cost-effective thresholds with 26% or 96% reduction in cost when compared to ddMVAC and GC, respectively. Randomized clinical trials, larger sample sizes and longer follow-up are required to better understand the value of ICIs as neoadjuvant treatments. [Table: see text]

Comparative effects of different types of tree nut consumption on blood lipids: a network meta-analysis of clinical trials

2019 ◽  
Vol 111 (1) ◽  
pp. 219-227
Author(s):  
Kai Liu ◽  
Suocheng Hui ◽  
Bin Wang ◽  
Kanakaraju Kaliannan ◽  
Xiaozhong Guo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Blood Lipids ◽  
Randomized Clinical Trials ◽  
Ldl Cholesterol ◽  
Meta Analysis ◽  
Control Diet ◽  
Sensitivity Analyses ◽  
Second Best ◽  
Different Types

ABSTRACT Background Recent evidence has confirmed that nuts are one of the best food groups at reducing LDL cholesterol and total cholesterol (TC). However, the comparative effects of different types of nuts on blood lipids are unclear. Objectives This network meta-analysis of randomized clinical trials aimed to assess the comparative effects of walnuts, pistachios, hazelnuts, cashews, and almonds on typical lipid profiles. Methods We conducted literature searches to identify studies comparing ≥2 of the following diets—walnut-enriched, pistachio-enriched, hazelnut-enriched, cashew-enriched, almond-enriched, and control diets—for the management of triglycerides (TGs), LDL cholesterol, TC, and HDL cholesterol. Random-effects network meta-analyses, ranking analyses based on the surface under the cumulative ranking (SUCRA) curves, and sensitivity analyses according to the potential sources of heterogeneity across the included studies were performed for each outcome. Results Thirty-four trials enrolling 1677 participants were included in this study. The pistachio-enriched diet was ranked best for TG (SUCRA: 85%), LDL cholesterol (SUCRA: 87%), and TC (SUCRA: 96%) reductions. For TG and TC reductions, the walnut-enriched diet was ranked as the second-best diet. Regarding LDL cholesterol reduction, the almond-enriched diet was ranked second best. The pistachio-enriched and walnut-enriched diets were more effective at lowering TG, LDL cholesterol, and TC compared with the control diet. Regarding TG and TC reductions, the pistachio-enriched diet was also more effective than the hazelnut-enriched diet. For TG reduction, the walnut-enriched diet was better than the hazelnut-enriched diet. However, these findings are limited by the low quality of evidence ratings. In addition, the quality of this network meta-analysis was limited by the small number and generally poor reporting of available studies. Conclusions The pistachio-enriched and walnut-enriched diet could be better alternatives for lowering TGs, LDL cholesterol, and TC compared with other nut-enriched diets included in this study. The findings warrant further evaluation by more high-quality studies. This network meta-analysis was registered at www.crd.york.ac.uk/PROSPERO as CRD42019131128.

The relationship between study design, results, and reporting of randomized clinical trials of HIV infection

1997 ◽  
Vol 18 (5) ◽  
pp. 431-444 ◽  
Author(s):  
John P.A. Ioannidis ◽  
Joseph C. Cappelleri ◽  
Henry S. Sacks ◽  
Joseph Lau
Keyword(s):  
Clinical Trials ◽  
Hiv Infection ◽  
Study Design ◽  
Randomized Clinical Trials ◽  
The Relationship

Study Design for Vitamin D Randomized Clinical Trials—Reply

2015 ◽  
Vol 175 (10) ◽  
pp. 1720
Author(s):  
Kirsti Uusi-Rasi ◽  
Radhika Patil ◽  
Kari Tokola
Keyword(s):  
Vitamin D ◽  
Clinical Trials ◽  
Study Design ◽  
Randomized Clinical Trials

Intention-to-Treat Analysis and Accounting for Missing Data in Orthopaedic Randomized Clinical Trials

2009 ◽  
Vol 91 (9) ◽  
pp. 2137-2143 ◽  
Author(s):  
Amir Herman ◽  
Itamar Busheri Botser ◽  
Shay Tenenbaum ◽  
Ahron Chechick
Keyword(s):  
Clinical Trials ◽  
Missing Data ◽  
Randomized Clinical Trials ◽  
Intention To Treat ◽  
Treat Analysis

Study Design for Vitamin D Randomized Clinical Trials

2015 ◽  
Vol 175 (10) ◽  
pp. 1720
Author(s):  
Richard L. Prince ◽  
Joshua Lewis ◽  
Peter R. Ebeling
Keyword(s):  
Vitamin D ◽  
Clinical Trials ◽  
Study Design ◽  
Randomized Clinical Trials

scholarly journals Brain Metastases Status and Immunotherapy Efficacy in Advanced Lung Cancer: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Hao Hu ◽  
Zhi-Yong Xu ◽  
Qian Zhu ◽  
Xi Liu ◽  
Si-Cong Jiang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Brain Metastases ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Advanced Lung Cancer ◽  
Tumor Type ◽  
Significant Difference

BackgroundBrain metastases (BMs) indicate poor outcomes and are commonly excluded in immunotherapy clinical trials in advanced lung cancer; moreover, the effect of BM status on immunotherapy efficacy is inconsistent and inconclusive. Therefore, we conducted a meta-analysis to assess the influence of BM status on immunotherapy efficacy in advanced lung cancer.MethodsElectronic databases and all major conference proceedings were searched without language restrictions according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We extracted randomized clinical trials on lung cancer immunotherapy that had available overall survival (OS) and/or progression-free survival (PFS) data based on the BM status. All analyses were performed using random effects models.ResultsFourteen randomized clinical trials with 9,089 patients were identified. Immunotherapy conferred a survival advantage to BM patients [OS-hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58–0.90; P = 0.004; and PFS-HR, 0.68; 95% CI, 0.52–0.87, P = 0.003]. Non-BM patients could also derive a survival benefit from immunotherapy (OS-HR, 0.76; 95% CI, 0.71–0.80; P <0.001; and PFS-HR, 0.68; 95% CI, 0.56–0.82, P <0.001). The pooled ratios of OS-HRs and PFS-HRs reported in BM patients versus non-BM patients were 0.96 (95% CI, 0.78–1.18; P = 0.72) and 0.97 (95% CI, 0.79–1.20; P = 0.78), respectively, indicating no statistically significant difference between them. Subsequent sensitivity analyses did not alter the results. Subgroup analyses according to tumor type, line of therapy, immunotherapy type, study design, and representation of BM patients reconfirmed these findings.ConclusionWe demonstrated that BM status did not significantly influence the immunotherapy efficacy in lung cancer, suggesting that both BM and non-BM patients could obtain comparable benefits.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier (CRD42020207446).

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