Sofia S. Villar is a member of the DART (Design and Analysis of Randomised Trials) group at the MRC Biostatistics Unit in Cambridge England. She has recently been awarded the first Biometrika post-doctoral research fellowship. 

In the post below Villar offers her position on how challenges in rare disease drug development may be alleviated by Bayesian-Bandit adaptive designs. The "Multi-armed Bandit" is an agent who tries to acquire new knowledge while trying to capitalize on existing knowledge. Clinical studies can therefore utilize bandit designs to recruit patients whose primary goal in participating in a trial is to improve their health outcomes.

Photos leaked from JSM 2014 appear to show the Reverend Bayes partying with his entourage at the Cytel Cocktail Hour, held at Boston’s Seaport Hotel on August 4, 2014. Bayes is, of course, one of the stars of Cytel’s East 6.3, a modular software package driving drug development through high quality trial design and simulations. Bayes's contributions to the East ESCALATE and East PREDICT modules are posited to transform early phase dose-escalation and interim decision-making. The Reverend has also made scene-stealing cameo appearances in a number of projects with Cytel Consulting.

Statisticians at Cytel are staunch advocates of the use of Bayesian methods in clinical trials. This summer's Joint Statistical Meeting will feature a panel on "Study Milestone Timeline Projection in Multi-Center Trials: Bayesian and Frequentist Approaches with Real-Life Applications" with three papers co-authored by Cytel experts. The Cytel papers will center on Bayesian  approaches for enrollment prediction, which is essential for proper trial forecasting and interim decision-making.

Do you design or analyze Phase 1 dose escalation trials? Have you considered methods other than 3+3? This new Cytel video demonstrates how East ESCALATE can help you to explore your options. 

Pantelis Vlachos, PhD, is a Director at Cytel Consulting. He works with a team of experts who regularly assist clinical study teams with the design and implementation of Bayesian methods. In this blog post, Pantelis describes key benefits of Bayesian analyses for clinical trials.

( Editor's note: This post has been refreshed in December 2016)

Model based algorithms for Phase I dose-escalation have been in existence for nearly thirty years. Despite guarantees of increased statistical power and greater accuracy, there remains a clear preference for rule based algorithms amongst clinicians. The explanation for this is as old as the models themselves.