The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’. The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data standardization also brings significant benefits to the industry- in the CDISC 2014 Business Case (1), it is noted that:
“For those developing regulatory eSubmissions, using updated baseline numbers for the time and cost of getting a drug to market, it can be found that ~ $180M can be saved per submission (18% of the total cost). An average of two years can be saved off of an average 12-year clinical development program lifecycle – just by standardizing data”.
It’s therefore critical that the biopharma and CRO industries develop the next generation of data managers, statisticians and programmers with strong knowledge of the CDISC standards.
Angelo Tinazzi has more than 20 years’ experience in data-management and statistical programming and is Director of Clinical Data Standards and Data Submission at Cytel. He has been a member of the European CDISC Committee since 2015 and is a member of the CDISC ADaM team. Taking the next step in his journey as a data standards expert, Angelo is now a "candidate trainer" with CDISC –working towards becoming an “Authorized CDISC Instructor”. In this blog we find out more from Angelo about his experiences and the role of the CDISC trainer.
Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the pharmaceutical industry. He is also an international speaker and best-selling SAS author. Most recently, Sunil contributes his knowledge as a CDISC Oncology ADaM reviewer and has taught his CDISC online classes with the University of California at San Diego. Sunil has MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
Recently, Sunil published a book, 'Sharpening your Advanced SAS Skills’ a follow up to his popular and well respected ‘ Sharpening your SAS Skills’. In this blog we find out more and offer blog readers the chance to win a copy of the new book!
Earlier this week, Patti Arsenault, Cytel’s Global Head of Clinical Data Management, sat on an SCDM panel with members of Gilead and Westat. The panel partook in an interactive discussion on both the opportunities and challenges which arise from managing virtual teams.
As teams become more global in nature – optimizing delivery by around the clock work hours –many have weighed in on the best way to manage virtual teams. Unfortunately, there seems to be very little agreement on such best practices. The panel provided insights from industry leaders in clinical data management, and then invited audience members to share their experiences.
Professor LJ Wei holds that rules are for lawyers, not (necessarily) clinicians. When designing modern clinical trials, the impetus is often to use “efficient and reliable procedures, to obtain clinically interpretable results with respect to risk-benefit analysis…” Yet these efficient and reliable procedures are often just conventions and rules that provide information that is incomplete or difficult to make clinically interpretable.
In a presentation to the East User Group Meeting, Professor Wei identifies 11 problematic areas that currently challenge trial designers. After giving an overview of the challenges that arise in each, Professor Wei provides a few simple solutions about how to overcome them. All the solutions, however, require moving beyond the comfort zone of conventional procedures.
In the slides attached Wei discusses:
Cytel has taken the initiative to train the next generation of clinical programmers through its innovative Clinnical Programming Laboratory [see Cytel's CliPLab].
What about training the next generation of statisticians? The Harvard School of Public Health has just awarded the 2014 Marvin Zelen Leadership Award in Statistical Sciences to a distinguished statistician and educator.
Although collaboration between industry and academia has been a longstanding tradition in the field of drug development, existing industry forces are reshaping the nature of this partnership. According to Cytel India's Chief Executive Ajay Sathe, the projected expansion of the drug development market between now and 2017, comes at a time when both industry and academia are challenged to supply new and innovative young talent. While some universities offer comprehensive programs in computation, programming, biostatistics and bioinformatics, such an all-encompassing curriculum is rare. Even when possible, the combined contributions of these disciplines to the day-to-day challenges of statistical analysis and data management are often difficult to comprehend without industry experience.