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

2020 Recap by Yannis Jemiai, Chief Scientific Officer, Cytel

December 17, 2020

As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation for statistical excellence and our track-record of bringing innovative analytic approaches to the development of medicines for human health. In this blog, we ask Yannis for his favorite Cytel events from 2020.

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Cytel and Ingress Health at Virtual ISPOR Europe 2020

November 24, 2020

Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR community. Cytel and Ingress Health, now a Cytel company, contributed to a range of events including interactive workshops, issue panels, on demand podium presentations and virtual poster presentations.

Continue reading for discussions on tracking COVID-19 trials, reflecting on the successes, opportunities and failures of real world solutions, and bridging the gap between real world data and clinical development.

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Role of Prediction and Causal Inference in Clinical Research

November 17, 2020

 

As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his research on applying machine learning for predictive analysis and evidence generation.

The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and AI techniques allow us to access and analyze any combination of a multitude of data sources. The way that traditional controlled sources are viewed is being adapted in light of new evidence that emerges from real-world data. In his presentation, Alind introduces us to the concept of ML and Causal Inference and discusses case studies from randomized clinical trials and real-world data.

Click the button to register for the on demand webinar.

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Join Cytel and Ingress Health at Virtual ISPOR Europe 2020

November 12, 2020

Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020, on November 16th – November 19th. Our Real-World analytics teams will be collaborating to deliver a number of interactive workshops, issue panels, posters and podiums to showcase their work and share innovative insights in HEOR, evidence generation, knowledge synthesis and decision analysis.

Click below to download our full list of sessions at ISPOR EUROPE and feel free to share this brochure with any colleagues who may find our sessions insightful.

download the  sessions schedule

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Key Design Considerations for Platform Trials

November 10, 2020

Platform trials are a new type of clinical trials where multiple interventions can be evaluated simultaneously against a common control group within a single master protocol. Platform trial designs are an extension of adaptive trial designs that are sometimes referred to as a multi-arm, multi-stage (MAMS) design, as multiple interventions (‘‘multi-arm’’) undergoing multiple interim evaluations (‘‘multi-stage’’) are part of the design features.

This autumn Cytel has been holding a number of webinars on Platform Trials, ranging from a discussion with Cyrus Mehta on statistical innovations to incentivize more sponsors to consider platform trials, to next week's event with Jason Connor (Confluence) on the use of Bayesian methods for these innovative trial designs. 

In a recent webinar Jay Park, Director of Trials Research for Cytel in Canada, presented a webinar to review the concept of platform trials and discuss important design considerations for platform trials. Jay is the author of several leading papers on Platform Trials, including one in CA: A Cancer Journal for Clinicians, the journal with the world's highest impact factor. He has also produced a complimentary primer on the subject which you can download here.

Continue reading this blog to get a summary of his talk. Click the button to access the on demand webinar.

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Role of RWA in Transforming Oncological Research

November 5, 2020

In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for a single arm trial. This potentially works for regulatory purposes (EMA/FDA). However, if they go to the local HTA authorities (NICE/CADTH), they will have to answer the question on the relative effectiveness of the new product compared to the standard of care in that country, and then its cost-effectiveness. Hence, typically, a manufacturer will identify a publication on a trial or real-world evidence on standard of care, or perhaps collect individual patient level data in clinical practice. Subsequently, it will conduct comparative effectiveness analyses for HTA purposes, a naïve comparison or an unanchored MAIC/STC/PSM of the single arm trial compared with the control arm.

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An Interview with Bart Heeg (Part 2): New Trends in HEOR

October 22, 2020

In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company). Bart provides us insights on the trends in HEOR and explains why Bayesian methods are also important for Health Economics. Read Part 1 here.

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Interview with Thomas Wilke: Health Economics and Real-World Evidence Studies

October 20, 2020

In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his background and experience in Health Economics, understand the important considerations of real-world evidence studies and the impact of COVID-19 pandemic on the work of the health economics outcomes researchers who work at Ingress and Cytel. We also cover important HEOR topics such as its benefits for market access studies and real-world analytics (RWA) for regulatory submission.

Cytel and Ingress-Health will be contributing to a range of events at Virtual ISPOR EU 2020, on November 16th – November 19th. Our Real-World analytics teams will be collaborating to deliver a number of interactive workshops, issue panels, posters and podiums to showcase their work and share innovative insights in HEOR, evidence generation, knowledge synthesis and decision analysis.

Click below to download our full list of sessions at ISPOR EU

download the  sessions schedule

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Upcoming Discussions: The Uniqueness of COVID-19 Real-World Data Challenges & The COVID-19 trial tracker

October 19, 2020

COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety, statistical rigor, and speed has prompted the rapid surge in the generation of clinical data. However, this information is scattered across multiple platforms, making it challenging to measure comparative treatment effects across trials. Consequently, we are seeing a high frequency of failures, that diminishes the public’s confidence in research and slows the path from scientific results to action.

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