Cytel Blog

Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan Ji.

Dr. Ji is a Professor of Biostatistics at The University of Chicago and a well-known name in the industry. In his presentation, he introduces representative Bayesian designs for dose-finding trials. The webinar offers insights on topics including classical DLT-based dose-finding designs, designs with delayed toxicity using time-to-event endpoints, and designs for combination dose-finding trial. Watch the on demand webinar to see the illustration of Bayesian modeling and inference for dose-finding designs that utilize the concept of probability intervals and related methods for clinical development and decision making.

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.

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.

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop. This series will expose you to cutting edge topics from industry renowned leaders in Bayesian statistics. The introductory webinar “Bayesian Statistics and FDA Regulatory Acceptability” is presented by Greg Campbell, PhD, Former Director of Biostatistics, U.S. Food and Drug Administration.

In the United States Bayesian statistics has been used in regulatory submissions to the Food and Drug Administration (FDA) for confirmatory clinical trials medical devices for more than fifteen years. In this webinar, Dr. Campbell reviews the Bayesian history and accomplishments for medical devices. He talks about the status and opportunities of Bayesian statistics for pharmaceutical drugs and biologicals. We also learn about the challenges and the future of Bayesian statistics in the regulatory environment. You can access the on demand webinar and register for the rest of the series by clicking the button.

Staying abreast of the rapid pace of clinical development means adopting innovative or computationally intensive designs like Bayesian methods. These methods allow for the incorporation of prior knowledge, in terms of either expert opinion from clinicians or historical data, in statistical inference. Thus, they have the additional advantage of being able to work with real-world data (generally, real-world data has a lot of missing data) without the need to impute missing values. These kinds of models are also flexible enough to work with temporal data. This helps ease the reliance on large sample approximations that are often required for frequentist methods and generally results in greater efficiency in study design.

In this edition of The Informative Bayesian by Pantelis Vlachos, we learn about information borrowing to form a prior distribution. In a Bayesian framework, borrowing from historical data is equivalent to considering informative priors. These priors can be derived as meta-analytic predictive (MAP) priors or using patient-level data.

Today, there is a need for advanced quantitative techniques to combine all available information for better decision making in health care. Bayesian statistics allow us to make probabilistic inferences on the parameter of interest, which is missing in a traditional frequentist approach. Apart from the philosophical issues, Bayesian analysis provides a practical and intuitive tool for interpretation of study results and risk evaluation of clinical hypotheses.

Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop. This series will expose you to cutting edge topics from industry renowned leaders in Bayesian statistics. Click the button to learn more and register.

Keeping up with the rapid pace of clinical development means that we need to adopt the innovative or computationally intensive designs like Bayesian methods. Yet, cutting edge technology can sometimes be difficult to assess or can introduce risk. Cytel’s new web-native extension of East, East Alloy^TM, makes it practical and sustainable to adopt innovative and computationally intensive designs. Continue reading this blog to learn more.

On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory, on how adaptive designs can be utilized to salvage trials disrupted by COVID-19. The Heart Failure Collaboratory is a public-private consortium with FDA, and will be hosting a day long symposium online, on the application of innovative methods for drug and device studies in the age of COVID-19.

Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East Alloy^TM. East Alloy is a new East environment that enables rapid access to innovation with the trust and support you have come to expect from Cytel. The cloud-native software makes it practical to apply computationally intensive Bayesian methods. Download the brochure to learn more.

This blog is a part of the new blog series on technology and Bayesian decision-making by Pantelis. Continue reading to learn about the methods and capabilities, such as, Bayesian meta-analytic priors, Bayesian MAMS, adaptive dose-finding and others, available to all East Alloy users.