Cytel Blog

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?

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a key topic in modern drug development, and this session aims to encourage statisticians to question the importance of a more patient-centric approach within their field.

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies in today’s climate of accelerated development. He also talks with us about his career in statistics, current research, and his book Quantitative Decisions in Drug Development.

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial and its Critics”.

In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they strive to improve their decision-making, and what delegates can expect to take away from the presentation.

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas Burnett, Robert Greene and Simon Kirby.

In this blog, we took the opportunity to talk to one of the speakers, Thomas Burnett, Senior Research Associate in Medical and Pharmaceutical Statistics at Lancaster University, about his presentation topic “Bayesian Optimization of Enrichment Designs” and his perspectives on what EUGM delegates will be able to take away from his talk.

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in the Fall, and delegates at the PSI conference in early June had the chance to grab a sneak peek of the new functionality in one to one demos.

We’ll also be opening the hood on the new design capabilities you can expect in East 6.5 at a complimentary webinar on Wednesday July 18, 11:00AM - 12:00 US EDT (16:00 UK, 17:00 EU).

Our presenters Pantelis Vlachos and Charles Liu, will introduce the 3 new available modules and share their insights on the supporting methodologies and their practical applications. New developments in the East software are typically derived from two sources: our team’s interaction with our customers, particularly during East training; and from our consulting practice when we help clients design their trials.

The new modules in East 6.5 include:
MCPMod (design with Multiple Comparisons Procedures)

MCPMod allows you to measure the likelihood that particular dose-response curves are the right mathematical model for a given set of data. East MCPMod will allow designing a trial using optimal allocation and then analyze the trial data using various dose/model selection criteria resulting
into a solid base (target dose) for the next phase confirmatory trial.

Population Enrichment (Adaptive designs)

An adaptive enrichment design allows the full population is segmented during interim analyses. Recently, we worked with TRACON Pharmaceuticals to design their TAPPAS trial that incorporated a population enrichment component to help overcome the potential heterogeneity of treatment effect between subpopulations for an angiosarcoma design.

Program-Level Design
It is important to take a strategic approach to clinical development to minimize the potential for Phase 3 attrition. This new module will help users apply simulations to optimize their clinical trial programs.
Click the button below to secure your place at the webinar. 

Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches helping to bridge the gap from methodology to implementation. Ultimately, our goal is to enable our audience to improve their chances of success in clinical development.

The series got underway in August with a webinar on ‘Phase 2 Trial Designs using Program-level Simulations, and Possible Adaptive Approaches’.

Model-informed drug development has been defined by Richard Lalonde ( Lalonde, 2007) (1) as “Development and application of pharmaco-statistical models of drug efficacy and safety from preclinical and clinical data to improve drug development knowledge management and decision-making”. It has  been identified by the FDA as an important way to help reduce attrition and uncertainty in drug development.
In a recent FDA Voice article,(2) FDA Commissioner Scott Gottlieb noted the critical role which modeling and simulation can play in making clinical development more efficient.

He commented that:
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development.”

In this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.