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

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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Data Standards and Submission Highlights from PHUSE EU CONNECT 2020

November 23, 2020

The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all of us missing the face-to-face contact.

The conference kicked-off on Sunday night with a Social Virtual event with a “Numerologist Show”. Of course this could not replace and compete with the usual “toast” we were used to do live, so we did it virtually (check out my LinkedIn post where I offer some cocktails recommendations and share the recipe of my favorite cocktail “The Negroni” with a bit of history. But please don’t do it before Friday night, you will need the weekend to recover).

Like every year, Cytel significantly contributed to the event as one of the official sponsors, running a workshop (“Predictive Analytics Using R”), chairing and co-chairing two streams (Machine Learning & Connected Health and Scripts and Macros), preparing four on demand presentations (in Application and Development, Coding and Tricks and Data Standards and Governance streams) and two posters.

In this blog, I focus on presentations related to data standards and data submission to agency, in general.

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10 Key Qualifications for Independent Statisticians Reporting to the DMC

November 19, 2020

Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created by an independent Statistical Data Analysis Center (SDAC) using interim data from ongoing studies. The role of the DMC is to make recommendations about the continuation of the studies based on their best judgment and sometimes specified guidelines.

The DMC typically includes at least one statistician who votes on the decision to recommend stopping, modifying, or continuing a study. The SDAC typically is represented by at least one independent statistician and these statisticians are intermediaries between the sponsor and the DMC. The SDAC independent statisticians facilitate the efforts of the DMC by preparing and presenting summary data, taking care of meeting logistics, etc. These SDAC statisticians need ‘hard skills’ such as expertise in biostatistics, experience with clinical trial data, and knowledge of the study protocol. But it is essential that these SDAC statisticians also have the ‘soft skills’ for this role. In this blog, we highlight 10 key qualifications for these SDAC independent statisticians that are less technical, but no less essential.

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We can design over 100,000 clinical trials in less than an hour. How do we choose from them?

November 18, 2020

The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago. Thanks to the advent of cloud-computing and advances in simulation technology, sponsors can now design hundreds of thousands of clinical trials in less than an hour. Yet how do we choose amongst all of these myriad options in a way that optimizes commercial prospects? Cytel’s Chief Scientific Officer sits down with us to discuss the Re-imagined Clinical Trial.

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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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Bayesian Methods for Multiple Cohort Expansion (MuCE) designs

November 16, 2020

MUCE is a Bayesian solution for cohort expansion trials where multiple dose(s) and multiple indication(s) are tested in parallel. Such methods are particularly important for areas like oncology where several doses and several indications must be tested for successful completion of early phase trials, and optimal choice of dose and population to move on from early phase to a reasonable dosage for Phase 3.

Note that for these situations the number of comparator arms for a trial can increase rather rapidly. Testing three doses with three indications essentially requires 9 different trials. An efficient way to test a higher number of trials is therefore necessary for accelerated clinical development.

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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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Interview with Yannis Jemiai: Advanced Design Framework

November 11, 2020

The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago, it would take a statistician perhaps two or three days to design five clinical trial designs, a well-resourced statistician can now simulate and model well over 100,000 designs in less than 30 minutes. How does this affect the process of designing clinical trials

According to Yannis Jemiai, Chief Scientific Officer at Cytel, a combination of technology and process changes can establish the foundation for significant increases in productivity. Yannis argues that uncertainty should not be viewed as a challenge but an opportunity. Using statisticians strategically as well as tactically throughout the design process can help R&D teams drive commercial value for greater speed, savings and success.

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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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