The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
PhUSE EU Connect 2019 was held in the beautiful city of Amsterdam between the 10th and 13th of November. This clinical data science conference comprised 19 Streams, including 150 papers, 24 posters and 3 engaging data scientists as keynote speakers. The event was well attended and had several interesting and innovative presentations. Caroline Terrill, Associate Director of Statistical Programming at Cytel UK, conducted a session “No Place Like Home: Managing Remote Programmers Remotely” and stood out as the winner in the Personnel Management category. Based on 5 years' experience of managing remote programmers, Caroline’s paper gives guidance on issues to be considered and traps to be avoided if you are managing people who work remotely.
In this blog, we share the presentations from our Statistical Programmers and summarize some of the sessions that our team members attended.
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.
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.
The "Master Recipe": Quality and Attention to Details Matter When Submitting CDISC Packages to Authorities
One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4 restaurants of the same style are assessed and the one getting the best evaluation wins the prize. One of the first things the TV presenter Alessandro Borghese, a famous Italian chef, does while visiting the restaurant is to assess (of course!) the kitchen and how much the kitchen and its tools are cleaned. This assessment could have a big impact on the final outcome regardless of the quality of the food served in the restaurant .... the state of the kitchen and its cleanliness influences Borghese’s faith in the chef’s work.
This is exactly what could happen in a data submission to health authorities such as the FDA: the efficacy and safety of your drug are of course what matter, but lack of traceability, or poor or insufficient documentation might trigger questions and concerns from the reviewer. While this might not impact the overall final outcome of your submission, approval could be delayed if the reviewer starts questioning what you have done by requesting changes, or new deliverables to clarify the aspects that were not sufficiently clear in your original submission.
We were excited to learn recently that Ajay Sathe, the CEO of our India Operations, was awarded lifetime honorary membership of PhUSE in recognition of his contributions to the influential statistical programming organization. Ajay is a well-known figure in the global statistical programming community and in this blog we chat with him about his work, the important role of PhUSE in the industry, and what excites him most about work in the biopharma sector.