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Statistical Consultancy Team

Statistical Consultancy Team

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

Nutraceutical trials: demand, design and challenges

Statistical Consultancy Team

Food ingredient and nutraceutical manufacturers are increasingly looking to market their products by substantiating their unique health benefits.

There are many generic, widely used claims - in the EU, Article 13.1 of the European Food Safety Authority’s (EFSA) EC Regulation permits manufacturers to use some 4,6371 that pertain to vitamin and mineral content.

This proliferation is driving manufacturers to develop unique claims to use in marketing efforts, which in turn has led to a significant growth in demand for nutraceutical trials.

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Topics: Regulatory Requirements, Clinical Study Design, Biostatistics Consulting, Statistics, Nutraceutical Trials

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

[Video] Bayesian Methodology - How to Analyse Multiple Endpoints

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Principal Statisticians, Sonia, presents an example of Bayesian Methodology using simulated data and examines how to analyze Multiple End Points in Clinical Trials.

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Topics: Bayesian Statistics, Bayesian Methods, SAS Programming, Statistics, Statistical Knowledge Share, Multiple Endpoints

[Video] Tipping Point Analysis in Multiple Imputation for Binary Missing Data

Statistical Consultancy Team

In this Statistical Knowledge Share Video our Senior Statisticians, Niccolo, presents an example on simulated data of Tipping Point Analysis in Multiple Imputation for Missing Data.

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Topics: Multiple Imputation, Statistics, Tipping Points Analysis, Missing Data, Statistical Knowledge Share

Risk-Based Monitoring and the Need for Programmers and Statisticians

Statistical Consultancy Team


The ICH E6 on Good Clinical Practice was updated on 9 November 2016, the first addendum for 20 years. Sections 5.0 on Risk and 5.18.3 on Extent and Nature of Monitoring in particular created an increased need for Risk-Based Monitoring (RBM) and Centralized Monitoring (CM). The details of how this may be covered and the increasing evolution of a risk in the industry have been noted. The required changes involved create a number of different team roles. These include opportunities for biostatisticians and statistical programmers - players who may not have been so directly involved in onsite monitoring, a more traditionally clinical domain.

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Topics: Source Data Verification (SDV), On-Site Monitoring, Visualization, Fraud Detection, Risk Based Monitoring, Centralized Monitoring, ICHGCP E6, International Conference on Harmonisation (ICH)

Patient Reported Outcomes (PRO) to Support Medical Product Labeling Claims

Statistical Consultancy Team

With encouragement from the U.S. Food and Drug Administration (FDA), using Patient Reported Outcomes (PRO) data to claim labeling became more and more popular. Well-defined and reliable PRO can be used to support a claim in medical product labeling. [1] It is found that there are an increasing number of regulatory submissions for new drugs to provide PRO data to support claims. DeMuro et al. (2013) [2] have reviewed drug approvals by both FDA and EMA for the years 2006–2010. They found that out of 75 drugs approved by the EMA, 35 (47%) had at least one PRO related claim approved by the EMA compared to 14 (19%) for the FDA.

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Topics: FDA, European Medicines Agency, Biostatistics Consulting, Patient Reported Outcomes, medical labeling, PRO Instrument, Electronica Patient Reported Outcome (ePRO), Statistical Analysis Plan

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

Methods for assessing early-phase equivalence in Biosimilars

Statistical Consultancy Team

Rheumatoid Arthritis (RA) is a long-term inflammatory disease that causes pain, swelling, 
stiffness and loss of function in joints, with an approximately 0.5 to 1% (and increasing) prevalence in adults worldwide.  Alongside many treatment options, 
there’s recently been an increased focus on producing biosimilars, with many new drugs expected to come to the market in the coming years [1]. 

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Topics: Phase I Studies, Biostatistics Consulting, Bioequivalence, Biosimilars, Bioavailability, Rheumatoid Arthritis (RA)

Is a MSc in Statistics the ‘be-all and end-all’ to a career as a pharmaceutical statistician?

Statistical Consultancy Team


The vast majority of pharmaceutical companies and Clinical research organizations (CROs) ask for an MSc in Statistics (or Medical Statistics) when hiring statisticians, claiming these degrees in particular provide adequate preparation and the necessary hands-on experience to work in the industry. However – how strict is this rule across different companies, and should this be a requirement? Can similar qualifications such as an MMath or PGDip (which can have a lot of crossover with traditional statistics MScs) be equivalent and provide the required statistical training for a successful career in industry? Or can a BSc be sufficient? I aimed to answer these questions by asking senior statistical leaders and recruiters for their views through 4 questions.

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Topics: Statisticians in the Pharmaceutical Industry (PSI), Clinical Research Organization, MSc Statistics, Careers, Graduates

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