With only two weeks left for this fabulous year to end, we would like to thank all our blog subscribers and new readers for following and appreciating the Cytel blog. This year, we collaborated with several experts from both within and outside the company to bring to you a range of interesting topics including real-world evidence, AI, challenges in rare diseases, patient-reported outcomes, data management, and our popular series “The Good Data Submission Doctor” and “Career Perspectives”. In this blog, we share with you the top 5 Cytel blogs that resonated most with our community in 2019.
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In September 2018, the FDA issued a new draft Guidance for Industry on Adaptive Designs for Clinical Trials of Drugs and Biologics. This guidance replaced the previously published 2010 draft. Natasa Rajicic, Principal, Strategic Consulting at Cytel reviewed the two documents to look for key differences and similarities between them, and identify any significant new elements introduced in the most recent material. In this blog post, we shared a handy infographic to illustrate how the two draft guidances stack up. According to Natasa's briefing note, the 2018 document provides more concise and focused guidance to take the industry forward into the next era of complex and innovative trials.
“The Good Data Submission Doctor” is a series of blogs authored by Angelo Tinazzi, Senior Director, Standards, Systems, CDISC Consulting, Statistical Programming and Clinical Research Services at Cytel. In this issue, Angelo gives us an insight on some of the good rules to live by when converting legacy terminology to CDISC-CT. There can be several challenges in converting legacy data to SDTM. One of the important ones is the application of the CDISC Standard Controlled Terminology (CDISC-CT) and other external dictionaries and standard (such as the ISO format for dates or the medical dictionary such as MedDRA for Adverse Events). These 10 rules can help you ease the conversion.
Cytel was delighted to have Kannan Natarajan as a keynote speaker at the “Complex Innovative Trial Design Symposium and East User Training” in November in Boston. Before the symposium, we sat down with Kannan for a wide-ranging discussion about his career in statistics, the changing role of statisticians, his views on evolving statistical thinking, estimands and relevance of technology in the context of rare diseases. Kannan is currently the Senior Vice President, Global Head of Biometrics and Data Management at Pfizer. He has over 20 years of experience in the industry. In this blog post, he explains why there is a need to move away from traditional study designs and statistical methods, and the increasing importance of innovation.
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics at Cytel. We spoke with Nand for a Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and how innovative approaches supported by thorough planning can meet these challenges head-on. The introduction to Phase 1 clinical testing is a significant milestone for any candidate medicinal product. However, the traditional development model leads to sizeable Phase I trial packages requiring multiple studies, each lasting for months. Our conversation with Nand reveals that with thorough planning and flexibly-written protocols, many objectives can be addressed in a single protocol to streamline the acquisition of data that hopefully justifies continuance to Phase 2.
In honor of Rare Disease Day 2019, Cytel shared a new podcast featuring our Strategic Consultant Ursula Garczarek discussing how innovative statistical approaches can overcome challenges in rare disease development. In this blog post, Cytel provides a summary of some of Ursula's key insights from working in rare diseases and interacting with regulatory agencies for complex and innovative designs. Cytel has supported many sponsors with the design and implementation of innovative trials to enable their rare disease development programs.