Cytel Blog

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.

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.

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.

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.

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on decades of experience increasing clinical development productivity. The Framework illustrates how advances in design processes and technology can help development teams deliver greater business results, unifying statistics and strategy in the era of cloud computing and making strategic use of well-resourced statisticians.

Measuring treatment effect during a clinical trial is often the source of much debate, particularly during rare disease trials that must stimulate investigations using small samples. Unlike statistically significant results, for which there are many tests, meaningful measures of treatment effect are still under development (Kieser 2012). Cytel statistician Ursula Garczarek wonders whether this holds true in the realm of small samples and small target populations. After all, does the summary statistic in such a small trial rely on many assumptions that might not correlate with reality?

Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on decades of experience increasing clinical development productivity. The Framework illustrates how advances in design processes and technology can help development teams deliver greater business results, unifying statistics and strategy in the era of cloud computing, and making strategic use of well-resourced statisticians.

The framework consists of three parts: Thoroughly Explore, Decide Together, and Communicate Trade-Offs. This week we take a deeper look into the second part of this Framework, revealing how to effectively incorporate varied perspectives to efficiently design innovative clinical trials. Opportunities for quantitative evaluation criteria and design without bias help R&D teams sift through the thousands of trial designs options to optimize for speed, success, and savings.

Pharmaceutical and biotech companies are under pressure to deliver more and deliver faster with fewer resources. The cost of drug development, failure rate and human cost associated with prolonged participation in a trial turn out to be steep in case of an ineffective trial. As the industry seeks new levels of clinical trial efficiency and probability of success, more companies are looking to use advanced, innovative and computationally intensive designs like Bayesian methods.

Bayesian methods are of growing interest to the drug development industry, as they allow clinical investigators to leverage historical trial data as well as learnings from new data as it accrues throughout a trial. The result is better-informed decision making, greater program flexibility, and the ability to run smaller, more resource-efficient trials.

Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar from the series is presented by Dr. Yuan Ji, a consultant for Cytel. Yuan is the founder of Laiya Consulting and currently is the Professor of Biostatistics at The University of Chicago. In his presentation, Professor Ji introduces the U-Design version 1.4, which mainly consists of a new module of dose-finding trial designs with joint efficacy and toxicity outcomes.

Click the button to register for the next webinar in this series, presented by Cytel's Ursula Garczarek. Ursula will be presenting a case study on the value of detailed clinical trial simulations for rare diseases.