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Statistical Consultancy Team

Statistical Consultancy Team

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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

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

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

The Trend in Biosimilar Development and Recent FDA Guidance

Statistical Consultancy Team

At the present time, the regulatory and drug development communities are adapting to a rising trend in biosimilar development in a number of therapeutic areas.

The regulatory framework for biosimilars in the US is still evolving; the number of biosimilars approved by the FDA in 2015 was 1, this rose to 4 in 2016 and is set to increase in 2017. The FDA is developing and consulting on draft guidance documents that will shape future trials, and at this early stage there are a number of legal issues to be agreed around licencing conditions, such as the period of exclusivity and the applicability of the biosimilar to all approved indications of the reference product. To put this in context with the European landscape, biosimilars have been approved and used in the EU for over a decade without highlighting any major safety concerns. As of April 2017, there were 28 approved biosimilars in the EU on 11 different biologics. However, there are aspects of the emerging FDA guidance that will almost certainly be reflected in the evolution of trial designs in the future, for products aimed at the US market.

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Topics: Regulatory Requirements, Pharmacokinetics and Pharmacodynamic, FDA, Clinical Study Design, European Medicines Agency, Bioequivalence, PK Analysis, Demonstrating Biosimilarity, Biosimilars

Therapeutic Areas for Wearable Devices in Clinical Trials

Statistical Consultancy Team

Wearable devices are currently growing hugely in popularity, with predictions that the market will grow to $25 billion by 20191. Many of these devices, like the FitBit or Jawbone, are fairly cheap and affordable to the public. With the rising prevalence of chronic conditions like obesity due to our increasingly sedentary lifestyles, the use of wearable technology is on the up. Although initially marketed to consumers wanting to track their health and fitness, many wearable medical devices are now being designed and their potential use in clinical trials could completely transform and revolutionise the pharmaceutical industry. The obvious benefits to incorporating wearables in clinical trials are a higher compliance rate and reduced dropout rate, because wearing a device to monitor various vital signs and endpoints can reduce the need for hospital visits. For the same reason, clinical trials could have a much higher uptake and recruitment rate. The large amount of additional data could mean a lower variability, so fewer subjects could be needed to achieve statistical power.  However, this concept is virtually brand new and has major questions that need to be answered before real progress in this area can begin.

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Topics: Therapeutic Areas, Wearables in Clinical Trials, Wearables

Should We Be Integrating Mobile Health Apps in Clinical Trials?

Statistical Consultancy Team

Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites. It is evident from the review of a range of literature that studies integrating some form of mobile health technology can be broadly categorised into a few phases of development: studies on the development of new devices, studies on the validity of functional wearable devices, studies comparing new device and conventional endpoints, and finally those studies which trial the device as a health intervention. This article aims to briefly discuss these phases with reference to examples of recent studies demonstrating some safety or efficacy endpoint relating to a newly developed device.

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Topics: Clinical Trials, Clinical Study Design, Biostatistics Consulting, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

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

Creating High Quality Graphics in Clinical SAS Programming

Statistical Consultancy Team

Utilizing the newer SAS graphical procedures such as SGPLOT and SGPANEL rather than the original SAS Graph procedures is becoming more and more popular in statistical programming through their many user friendly utilities, such as overlaying multiple graphics and adding reference lines with ease. However, as with its predecessor, SAS Graph, any requirement for restructure of the graphical elements still proves to be relatively rigid when sticking to these core graphical procedures. This usually results in creating bespoke program code for each figure which undoubtedly takes time and also runs the risk of inconsistencies across figures.

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Topics: Clinical Programming, SAS Programming, SAS Graph, PROC Template

Delayed-entry models using PROC PHREG in Survival Analysis

Statistical Consultancy Team

Time-to-event data often arise in clinical research, and in many cases represent the primary outcome of interest. These data generally represent the elapsed time between a reference time-point (e.g., treatment randomization) and an event of interest (e.g. death, relapse, etc.).

Whereas right censoring is a feature that is easily accommodated by most existing software, the same doesn’t strictly hold for another feature of survival data, left-truncation. In this post we’ll describe what left-truncation is, when it can arise and provide some SAS code that can be used to derive survival estimates and curves. 

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Topics: Survival Analysis, Statistical Programming, SAS Programming, SAS, PROC PHREG

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