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

Making the Most of Your Observational Data: Creating a Synthetic Control from Your Natural History Study

August 7, 2020

Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. Regulators had requested a natural history of disease study, which tracks disease progression in the absence of any form intervention. These studies are used to build disease-models that can then inform a range of development opportunities within a drug development program.

A March 2019 FDA Guidance highlighted the importance of such studies for rare diseases, with former FDA Director Scott Gottlieb acknowledging that a lack of knowledge about the natural history of certain diseases is a significant obstacle in rare disease drug development.

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Bayesian Methods for Contending with Homogeneity and Heterogeneity in Real World Data

February 25, 2020

Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted. Whereas placebo-controlled randomized control

 trials remain the gold standard, in some situations, single arm trials have become an accepted way of assessing a new treatment intervention. Single arm trials establish clinical benefit by demonstrating the positive effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, alternative approaches of establishing the comparison 
are used; these have become known as external controls or synthetic control arms (SCA henceforth) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data.   
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Ensuring an Unbiased Comparator Arm

February 25, 2020

Regulators in both the United States and Europe have responded positively to the use of SCAs in clinical development.[1]  While implementation of this method for 

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Impact of AI on Clinical Development

December 10, 2019

In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September 11, 2019 at UCB’s offices in Slough, Berkshire. The primary agenda was to educate the audience on Artificial Intelligence (AI) approaches and their impact on clinical development.

With recent advances in AI, it is important for quantitative scientists to keep up to date with the most recent methods and be involved in guiding their application to the most pressing analytical challenges. This one-day event covered cutting edge examples of how data science and statistical sciences are intersecting, and its relevance to our attendees.

“Artificial Intelligence and associated methodology is becoming increasingly important to the Pharma Industry and its technical foundation in statistical theory means that PSI is naturally keen to promote good practice through its membership and established Industry links. PSI is proud to have set up a Special Interest Group in this field and is keen to broaden its links and membership.”

- PSI Data Science special interest group

In this blog, we share some of the key takeaways from the symposium. If you are interested in attending similar sessions, you can check Cytel’s list of upcoming events here.

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