The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

The Good Data Submission Doctor - New ADaM Implementation Guidance

October 23, 2019

 

 
October 3, 2019 was an important day for the ADaM team as it marked the release of the ADaM Implementation Guidance (Ig) 1.2. Download the new guidance from the CDISC website here.


In 2018, several previews of the new Ig were made at CDISC Interchanges all around the world and at PhUSE conferences, it was only a few weeks ago that the final version was released. At first glance, the new Ig does not seem to contain a lot of new concepts and ideas. However, a critical and in-depth review clearly shows the efforts of the entire team to release this new Ig. Creating a new standard or releasing a new version of an existing standard is not an easy job. You need to ensure that you do not introduce anything that contradicts any of the existing CDISC standards. This includes, not only new variables but also any changes in existing sentences or adding entirely new sections that may cause misinterpretations or discrepancies. Moreover, every standard team member comes with their own background, company needs, and specific indication needs. It is not always easy to propose a solution that can satisfy everyone on the team.

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Handling the specialized data requirements in oncology clinical trials

June 27, 2019

 

 

 

By Nicolas Rouillé and Eric Henniger

The right design and the right data ultimately leads to the right decisions, so obtaining fit-for-purpose data, collected based on what your protocol is looking for is vital. However, there are several data pressure points facing oncology drug developers that need specialized expertise and processes to handle. In this blog, we run through some key aspects to consider to smooth your data collection and analysis.

 

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New Year Round-Up: Your Favorite Posts of 2018

January 8, 2019

Happy New Year! As we look ahead to future successes and the new advancements in drug development that 2019 will bring, we are taking a moment to reflect on the topics that resonated most with our community on the Cytel blog in 2018. While these 6 most popular blogs encompass a variety of topics from across the data science, statistics, and statistical programming space, they all have in common a focus on innovative practices and application of statistical, data management, and data science excellence to achieve better outcomes in drug development.

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Highlights from the PhUSE EU Connect

December 11, 2018

PhUSE EU Connect 2018 took place in Germany’s financial capital Frankfurt, 4th - 7th November and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. The agenda was superb with 143 presentations in 16 different streams and nearly 30 posters. This year’s event theme ‘Future Forward’ did not disappoint and there were some very thought-provoking talks on the drug development industry's challenges and  what we can do in the future to meet these challenges. Additional hot topics were: Analytical Risk Based Monitoring, Machine Learning, and Data Standards and Governance. We found this year's event informative and well attended. 

In this blog, we share the contributed posters and presentations from our Statistical Programmers and summarize some of the particular highlights from the sessions and posters that our team members attended.

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The Good Data Submission Doctor: 5 Top ADaM Frequently Asked Questions

November 27, 2018

 

This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards, Systems and CDISC Consulting at Cytel tackles key issues in preparing data for CDISC submission. In the previous “Good Data Submission Doctor” blog Angelo discussed his top 5 SDTM FAQ; in this article he turns his attention to the top FAQs for  ADaM. Read on for Angelo's insights.

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The Good Data Submission Doctor: 5 Top SDTM Frequently Asked Questions

November 1, 2018

 

In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention to Detail Matter here) I would like to go through some of my favorite SDTM Frequently Asked Questions. These are questions I regularly receive in my capacity as a CDISC Subject Matter Expert, either from my colleagues or from the sponsor. Let’s start by taking a look at five of the most recent.

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