Cytel Blog

Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s in clinical development. The desire to speed up and lower the cost of drug development, coupled with increased availability of rich real-world data, contributed to the increased willingness towards using SCAs as supplementary evidence to accompany regulatory submissions using single arm trial data only.

As with any sophisticated statistical method, deciding on the optimal SCA approach is a necessary condition to ensure robustness of findings. Cytel’s new audiobook "Demystifying synthetic control arms", explains the concept of synthetic controls and offers insights on some common quantitative strategies for trial design and regulatory submission. Continue reading this blog to learn more and get access to the audiobook.

Research Scientists, Thomas Wilke and Sabrina Mueller recently published a manuscript on “Diabetes-Related Effectiveness and Cost of Liraglutide or Insulin in German Patients with Type 2 Diabetes: A 5-Year Retrospective Claims Analysis”.

As insulin and liraglutide are both treatment options for type 2 diabetes mellitus (T2DM), it was important to understand their long-term real-world outcomes. A retrospective study was conducted using administrative claims from a German health fund (AOK PLUS) and clinical data; the clinical data was collected in a disease management program. This claims data analysis, in adult patients with T2DM, investigated diabetes-related effectiveness and costs with long-term (up to five years) treatment with liraglutide or any insulin, in a real-world setting.

Continue reading this blog to learn about the unique insights that were gained during this project and get access to the publication.

Cytel has designed and implemented a novel adaptive platform trial for early stage COVID-19. The severity of the coronavirus emerges in five stages, with the majority of clinical trials focusing on therapies for the final stage of the disease. According to the Cytel Clinical Trial Tracker, only 6 of 2000 trials are focused on early stages; staggering given that only 5% of coronavirus cases are considered severe.

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.

Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate the control arm of a study. When enrollment targets are low and large amounts of data already exist about the performance of a control, then in many cases using quantitative techniques to simulate a control arm of a trial will expedite timelines and serve as a more optimal use of resources.

Cytel’s new audiobook "Demystifying synthetic control arms", provides insights on synthetic controls, suitable conditions for their use, and some common quantitative strategies for trial design and regulatory submission. Click the button download the audiobook.

In clinical trials with small or sparse data, statistical methods meant for large sample sizes may not be helpful to get an accurate interpretation of data. This is where computationally challenging exact methods often come into play. Chris Corcoran, David B. Haight Professor of Analytics in the Huntsman School of Business, is presenting at a Cytel webinar where he will introduce some basic exact statistical procedures provided in Cytel’s StatXact®. The software offers more than 160 tests and procedures for exact inference and power analysis.

Join Chris Corcoran in this example-based discussion where he will illustrate why exact analysis can be crucial in providing accurate results in some very common settings, particularly those involving small or sparse samples. Click on the button to register for the webinar.

“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to put on top (the After) when your regulatory group has finally submitted the eCTD to the FDA^[1] . A good start is to have early discussions with the agency by regularly meeting them and sharing the status of your clinical data standards. While, the cherry on the top is the continuous support you need to guarantee to your submission project to promptly react when the reviewers come back with questions and additional requests during the review process.

Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They 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) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data.

Is your Trial a Candidate for a Synthetic Control Arm? Continue reading this blog to learn more.

Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His presentation helps us understand the value of designing clinical trials considering downstream consequences. Watch the on demand webinar to get insights on the role of simulation in optimizing clinical trials' performance from a program perspective and understanding the hybrid Bayesian-frequentist approach to clinical trial design.

We also had the opportunity to interview Nitin about his journey since he co-founded Cytel and got his views on implementing a program-wide strategy for pharma and biotech companies. Read the blog here.

Continue reading this blog for key highlights from the webinar.