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FDA Guidance for Human Gene Therapy for Hemophilia A & B

Statistical Consultancy Team

Having seen an increasing number of gene therapy approvals, the FDA has issued draft guidance1 to help the developers of human gene therapy (GT) products for the treatment of hemophilia A & B.  In this article we will be focusing our attention on what guidance has been provided about the design of human gene therapy clinical trials for hemophilia A & B, including what is needed to support an accelerated approval approach. 

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Topics: rare diseases, Clinical Trials, FDA, hemophilia, Statistical Consultancy, Phase I Studies, Phase 2 Studies, Phase 3 Studies, Phase 4 Studies, Regulatory Requirements, Clinical Study Design, Additional Monitoring

Statistical Methods in Risk Based Monitoring

Statistical Consultancy Team

This blog explores the statistical methods used in Risk Based Monitoring (RBM) and how the result of such statistical methods enables improved data integrity across a clinical trial.

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Topics: Statistical Consultancy, Laboratory Datasets, ICHGCP E6, Risk Based Monitoring, Statistics, Centralized Monitoring

[Published Journal] Using Observational Studies to Investigate the Relationship Between Fatigue and Work Disability

Statistical Consultancy Team

Our Statistical Consultancy Team recently collaborated on a study to investigate the long-term relationship between fatigue and work disability in patients initiating treatment with etanercept for rheumatoid arthritis (RA) or ankylosing spondylitis (AS); and this work has now been published. (https://arthritis-research.biomedcentral.com/articles/10.1186/s13075-018-1598-8)

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Topics: Statistical Consultancy, Observation Longitudinal Database, Observational Studies, Inflammatory Rheumatic Diseases, Rheumatoid Arthritis (RA)

Bayesian approaches to use historical data in the analysis of clinical trials

Statistical Consultancy Team

The BAYES 2018 Bayesian Biostatistics workshop took place from the 20th to the 22nd of June, and was an extraordinary chance to discuss how Bayesian methodology can be used within the pharma industry.

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Topics: Bayesian Study Design, Bayesian Methods, Bayesian Statistics, Historical Data, Statistical Consultancy, Statistics, Biostatistics Consulting, Clinical Study Design

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