As we prepare to close the door on 2017, we thought we would take a look back at the topics which have been most popular on the Cytel blog this year. It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar. Read on to learn which of our 2017 blogs have received the most interest from our audience so far.
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD) characteristics, and of course identify the maximum tolerated dose (MTD). Conventionally, SAD and MAD studies were conducted separately, but increasingly are combined into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.
This approach can result in both time and cost savings, and allow additional valuable information to be gained earlier to inform subsequent development.
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It's not a surprise that this has been an extremely well read and popular post. Mouna Akacha kindly joined us for a blog interview and provided an invaluable primer for anyone new to the topic of estimands. This is an area which has been at the forefront of statistics discussions in 2017 and is likely to continue as a hot topic in 2018.
Mouna Akacha is a Consultant in the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland. She has a wide range of research interests including topics on missing data, longitudinal data and recurrent event data and is an active participant in the current estimand discussions.
Click here to read the interview or click the button below to download a .pdf copy to read later.
In an era of new technologies, and increasing volume of information, visualizations can help us to express complex data simply and effectively. Advanced technology is now available that allows statisticians and data scientists to drill down into the data sets to be analysed, and develop dynamic graphics that one can interact with. This marks a leap forward in decision-making capabilities from the static figures which have been traditionally available to us. Cytel statistical programmers presented a hands-on workshop at the PhUSE 2017 conference in Edinburgh and this blog provided a peek into some of the highlights. In 2018 we plan to share more content in this dynamic and booming area.
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Population modeling and simulation can be conducted using a variety of software including S-Plus, R, Phoenix WinNonLin ,SAS (PROC NLMIXED), MatLab and Phoenix NLME. One software commonly used for POP PK/PD modeling in clinical pharmacology research is NONMEM. This is a powerful tool, but with highly defined formats required, dataset creation can be a time-consuming process.
To increase efficiency as well as reduce the opportunities for errors, software developers and statistical programmers in Cytel’s Quantitative Pharmacology and Pharmacometrics group have developed an automated approach using SAS. In this blog, they share a poster presentation on the approach.
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In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shared some of the most important knowledge he uses in his day to day work as a biostatistician working extensively in oncology research. Adam has broad experience with statistical analysis and methodology over all phases (I-IV) of development, in particular working in the oncology arena. During his career, he has developed a particular focus on oncology trials, so in this blog he shares his insights into the knowledge he has found particularly vital as a biostatistician working in this area.
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We are sneaking this topic into the mix, as while it wasn't published during 2017, this blog has been consistently popular. To close a clinical database right the first time you have to begin with study start-up. Clearly, you can’t close a database if the data is not cleaned and you can’t have clean data unless you know what is most important for analysis. It’s imperative that data management works closely with the statistics group during CRF/ eCRF design to ensure data is being collected and data checks are being written in a meaningful fashion.
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We'd love to hear your thoughts on the hot topics you'd like to see covered in 2018. To make a suggestion or even register your interest in participating in our expert interview series, please email firstname.lastname@example.org.
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