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The Analysis of Direct and Indirect Pathways in Observational Studies

Statistical Consultancy Team

The blog was orginally presented by one of our statistical consultants at the Statisticians in the Pharmaceutical Industry (PSI) 2017 conference.

Inflammatory rheumatic diseases, such as ankylosing spondylitis (AS), are a major cause of work disability. Despite clinical progress in inflammation control and associated improvements in outcomes, work disability remains an issue for AS patients, and other underlying causes, such as fatigue, have been postulated. We have used data from an observational study, which followed a large cohort of AS patients in routine clinical practice for 12 months, to investigate the longitudinal relationship (data at baseline, 6 and 12 months) between fatigue and work disability in the presence of other recognised confounders. Initial results suggested possible inter-relationships between the effects of fatigue and anxiety/depression, leading to a post-hoc hypothesis that:

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Topics: Biostatistics Consulting, Statisticians in the Pharmaceutical Industry (PSI), SAS Macros, Statistics, Observational Studies, Inflammatory Rheumatic Diseases, PROC GENMOD

Top 3 Examples of Interactive Clinical Data Visualizations

Statistical Consultancy Team

Nowadays, vast amounts of data are collected during any clinical trial and it is essential for pharmaceutical sponsors to understand these data in great detail to make accurate decisions.

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Topics: Adverse Events (AEs), SDTM, Biostatistics Consulting, ADaM Datasets, Visualization, Technology Trends, Statistics

Integrated Summaries of Safety & Efficacy for Regulatory Submissions

Statistical Consultancy Team

Far from being simply a summary of individual results, a comprehensive and detailed summary allows companies to make informed decisions. Producing comprehensive integrated summaries of safety and efficacy is a critical stage of the submission life cycle. These need to be designed and planned carefully in advance to ensure informed decision-making and effectiveness at the regulatory interface. A focus on the approval and whole lifecycle of the product, and not just the submission, will influence the quality and direction of the content. Traceability is key in all respects of the creation of information, from data that leads to knowledgeable decisions and the ultimate wisdom that forms the label of a product.

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Topics: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Medical Writing, Biostatistics Consulting, Phase 3 Studies, Phase 2 Studies, Statistics

Understanding the Proportional Odds Assumption in Clinical Trials

Statistical Consultancy Team


Ordinal scales are commonly used to assess clinical outcomes; however, the choice of analysis is often sub-optimal.  In 2007, the Optimising Analysis of Stroke Trials (OAST) collaboration showed that ordinal-appropriate analyses of ordinal stroke outcome scales were preferable over binary analysis of a chosen ‘favourable’ outcome[1] but uptake of ordinal methods between 2007 and 2014 has been low [2].

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Topics: Randomization, SAS Programming, Biostatistics Consulting, Statistics, Ordinal Logistic Regression, Proportional Odds Assumption, PROC Logistic, Neurology

Celebrating International Clinical Trials Day

Marketing Quanticate

Happy International Clinical Trials Day! For those of you who do not know, International Clinical Trials Day is celebrated each year on 20th May. The event was created to commemorate the day James Lind started the first ever clinical trial to try and cure the deadly disease scurvy.

The clinical trial James Lind conducted consisted of using citrus fruit to cure scurvy. At the time the concept of vitamins were unknown, today we know scurvy is a result of vitamin C deficiency. James Lind was the first to study the effects of citrus fruits by conducting a systematic experiment on sailors in 1747 which is now regarded as one of the first clinical experiments in the history of medicine. 

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Topics: Clinical Trials, Ethics, Clinical Data Services, Statistics, International Clinical Trial Day

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