FEATURED ARTICLES

• Use Of Scoring Functions For Clinical Trial Optimization

  Cytel provides an overview of how Scoring Functions can be implemented for enhanced clinical trial selection.

• Mathematical Methods For Clinical Trial Financial Strategy

  When Cyrus Mehta introduced the Promising Zone Design over a decade ago, the new statistical method not only transformed the allocation of scarce resources within a clinical trial setting but also the design reconceptualized how sponsors could increase investment in their trials. Read about the Promising Zone Design in the available blog post.

• Use Of Rolling-Enrollment Designs To Accelerate Clinical Trials

  Cohort-based enrollment can thus slow down dose-finding trials since the outcomes of the previous cohort must be fully evaluated before the next cohort can be enrolled. This type of cohort-based designs can also be inefficient, especially if the trial needs to be frequently suspended. Read how to shorten the study duration of phase I trials and reduce the number of accrual suspensions with the use of rolling-enrollment designs is recommended which allows concurrent patient enrollment that is faster than cohort-base enrollment.

• Thinking Of Clinical Development From A Bayesian Lens

  Program and portfolio optimization creates a framework throughout the course of the clinical development journey, that enables trial sponsors to make decisions about when to continue a clinical trial. Learn where Bayesian methods should be injected into the process of optimization at the program and portfolio level.

• Utilizing Bayesian Analysis To Make Go/No-Go Decisions In A Platform Trial

  In recent years, platform clinical trials have gained substantial support and provide an efficient way of testing multiple compounds in a single and consistent framework. In this presentation we review platform trials including terminology, protocol structure overview and discuss some of the key advantages. We also share a concept for a platform trial that utilizes Bayesian modeling to make Go/No-Go decisions and discuss the potential benefits and risks of a platform trial.  

• A Data-Infused Approach To De-Risking Clinical Trials

  For many decades the Pareto Frontier has been employed by actors in the private sector to evaluate and understand the benefits of various strategic options. When trying to understand the risks and benefits of a clinical strategy, Cytel researchers urge using a modified version of this process, built primarily with clinical development in mind. In this blog learn more about using the Pareto concept in clinical strategy and decision-making.

• Selecting A Clinical Trial Design: How Broadly Should You Explore?

  When selecting clinical trial designs, how many design options should a sponsor explore? Would a sponsor feel more confident having an optimized design out of ten potential ones, or simulating several million designs to discover that there are three or four better options? Cytel’s experience suggests that this depends very much on the specific sponsor and the specific conditions of the clinical trial. Here are five considerations for sponsors when making this complex decision.

• Bayesian Methods & Vaccines Research: COVID-19

  The urgent need to discover and assess the efficacy and safety of COVID-19 vaccine candidates will affect the future clinical development of all infectious disease vaccine candidates, including those for diseases like tuberculosis. This blog reviews the design features of these clinical trials, and why Bayesian methods reduced risk and generated scientific findings more quickly.