Cargando…

Statistical design of Phase II/III clinical trials for testing therapeutic interventions in COVID-19 patients

BACKGROUND: Because of unknown features of the COVID-19 and the complexity of the population affected, standard clinical trial designs on treatments may not be optimal in such patients. We propose two independent clinical trials designs based on careful grouping of patient and outcome measures. METH...

Descripción completa

Detalles Bibliográficos
Autores principales:	Rai, Shesh N., Qian, Chen, Pan, Jianmin, Seth, Anand, Srivastava, Deo Kumar, Bhatnagar, Aruni
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2020
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456751/ https://www.ncbi.nlm.nih.gov/pubmed/32867708 http://dx.doi.org/10.1186/s12874-020-01101-z

Ejemplares similares

Adaptive Signature Design- review of the biomarker guided adaptive phase –III controlled design
por: Bhattacharyya, Arinjita, et al.
Publicado: (2019)

Workplace Culture and Biomarkers of Health Risk
por: Shuck, Brad, et al.
Publicado: (2022)

Standardizing Proteomics Workflow for Liquid Chromatography-Mass Spectrometry: Technical and Statistical Considerations
por: Srivastava, Sudhir, et al.
Publicado: (2019)

Coronavirus (COVID-19): A Systematic Review and Meta-analysis to Evaluate the Significance of Demographics and Comorbidities
por: Bhattacharyya, Arinjita, et al.
Publicado: (2021)

Statistical Issues and Group Classification in Plasma MicroRNA Studies With Data Application
por: Rai, Shesh N, et al.
Publicado: (2020)

The effects of long COVID-19, its severity, and the need for immediate attention: Analysis of clinical trials and Twitter data
por: Bhattacharyya, Arinjita, et al.
Publicado: (2022)

Microbiome data analysis with applications to pre-clinical studies using QIIME2: Statistical considerations
por: Rai, Shesh N., et al.
Publicado: (2019)

Statistical methods for analysis of single-cell RNA-sequencing data
por: Das, Samarendra, et al.
Publicado: (2021)

Distribution based nearest neighbor imputation for truncated high dimensional data with applications to pre-clinical and clinical metabolomics studies
por: Shah, Jasmit S., et al.
Publicado: (2017)

Statistical Approach of Gene Set Analysis with Quantitative Trait Loci for Crop Gene Expression Studies
por: Das, Samarendra, et al.
Publicado: (2021)

Statistical Approach for Biologically Relevant Gene Selection from High-Throughput Gene Expression Data
por: Das, Samarendra, et al.
Publicado: (2020)

Differential Expression Analysis of Single-Cell RNA-Seq Data: Current Statistical Approaches and Outstanding Challenges
por: Das, Samarendra, et al.
Publicado: (2022)

Circulating angiogenic stem cells in type 2 diabetes are associated with glycemic control and endothelial dysfunction
por: Zafar, Nagma, et al.
Publicado: (2018)

Statistical Approach for Gene Set Analysis with Trait Specific Quantitative Trait Loci
por: Das, Samarendra, et al.
Publicado: (2018)

Evidence and magnitude of the effects of meteorological changes on SARS-CoV-2 transmission
por: Kaplin, Adam, et al.
Publicado: (2021)

Benzene exposure is associated with cardiovascular disease risk
por: Abplanalp, Wesley, et al.
Publicado: (2017)

Pre-Existing Comorbidities Diminish the Likelihood of Seropositivity after SARS-CoV-2 Vaccination
por: Amraotkar, Alok R., et al.
Publicado: (2022)

Multigroup prediction in lung cancer patients and comparative controls using signature of volatile organic compounds in breath samples
por: Rai, Shesh N., et al.
Publicado: (2022)

A Comprehensive Survey of Statistical Approaches for Differential Expression Analysis in Single-Cell RNA Sequencing Studies
por: Das, Samarendra, et al.
Publicado: (2021)

Fifteen Years of Gene Set Analysis for High-Throughput Genomic Data: A Review of Statistical Approaches and Future Challenges
por: Das, Samarendra, et al.
Publicado: (2020)

Interactive Web Tool for Standardizing Proteomics Workflow for Liquid Chromatography-Mass Spectrometry Data
por: Srivastava, Sudhir, et al.
Publicado: (2019)

Optimal designs for phase II/III drug development programs including methods for discounting of phase II results
por: Erdmann, Stella, et al.
Publicado: (2020)

Multi-group diagnostic classification of high-dimensional data using differential scanning calorimetry plasma thermograms
por: Rai, Shesh N., et al.
Publicado: (2019)

Phase II trial of the regulatory T cell-depleting agent, denileukin diftitox, in patients with unresectable stage IV melanoma
por: Telang, Sucheta, et al.
Publicado: (2011)

Dynamic alteration in miRNA and mRNA expression profiles at different stages of chronic arsenic exposure-induced carcinogenesis in a human cell culture model of skin cancer
por: Banerjee, Mayukh, et al.
Publicado: (2021)

Identification of a plasma metabolomic signature of thrombotic myocardial infarction that is distinct from non-thrombotic myocardial infarction and stable coronary artery disease
por: DeFilippis, Andrew P., et al.
Publicado: (2017)

Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review
por: Antoniou, Miranta, et al.
Publicado: (2016)

Multistage designs for phase II clinical trials: statistical issues in cancer research.
por: Kramar, A., et al.
Publicado: (1996)

Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review
por: Antoniou, Miranta, et al.
Publicado: (2017)

Laparoscopic surgery for endometrial cancer: increasing body mass index does not impact postoperative complications
por: Helm, C. William, et al.
Publicado: (2011)

Assay Reproducibility in Clinical Studies of Plasma miRNA
por: Rice, Jonathan, et al.
Publicado: (2015)

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design
por: Levin, Bruce, et al.
Publicado: (2011)

Integrated Multilayer Omics Reveals the Genomic, Proteomic, and Metabolic Influences of Histidyl Dipeptides on the Heart
por: Yan, Keqiang, et al.
Publicado: (2022)

Statistical inference for extended or shortened phase II studies based on Simon’s two-stage designs
por: Zhao, Junjun, et al.
Publicado: (2015)

A gated group sequential design for seamless Phase II/III trial with subpopulation selection
por: Miao, Guanhong, et al.
Publicado: (2023)

Lung Cancer Clinical Trials with a Seamless Phase II/III Design: Systematic Review
por: Palermos, Dionysios, et al.
Publicado: (2022)

Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo
por: Horie, Yoshiharu, et al.
Publicado: (2009)

A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever
por: Olayinka, Adebola Tolulope, et al.
Publicado: (2022)

Improving pediatric multiple sclerosis interventional phase III study design: a meta-analysis
por: Graves, Jennifer S., et al.
Publicado: (2022)

Genetic polymorphisms predict response to anti-tumor necrosis factor treatment in Crohn’s disease
por: Netz, Uri, et al.
Publicado: (2017)

Cannot write session to /tmp/vufind_sessions/sess_0efqmreu55djs9ov2ufuujffhk