Featured Articles
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Bayesian Methods & Vaccines Research: COVID-19
5/14/2021
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.
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Reaping The Benefits Of Bayesian Innovation
5/14/2021
In the era of modern clinical development, several companies are turning towards novel and innovative approaches such as Bayesian methods, to minimize costs, accelerate time-to-market and boost efficiency. Learn about some advantages of using Bayesian trial designs and the challenges faced in the process and a new solution that broadens and simplifies access to complex Bayesian clinical trial designs.
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Empowering Statisticians To Create Complex Bayesian Clinical Study Designs
5/14/2021
Finding the right dose in Phase 2 gives a potential new therapy its best chance to demonstrate efficacy during Phase 3, and Bayesian techniques prove to be useful for optimal dose-finding. Review the dose-finding design options available today.
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Trial Selection: From Art To Science
5/14/2021
Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art, and not enough like a science.” The ad hoc nature of some clinical trial selection processes, raise concerns about whether or not the optimal clinical trial has been chosen for a sponsor’s specific needs. The new science of the re-imagined clinical trial makes trial selection more scientific by quantifying resource allocation and prioritization of commercial objectives, and then making data-driven clinical trial selection which provides a strong sense of opportunity costs.
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Identifying Choice Trial Designs Using Pareto
5/14/2021
This position paper reviews how the idea of Pareto Efficiency, also called Pareto Optimality, can be used for the strategic selection of a clinical trial design, rapidly identifying which designs are most aligned with an organization’s business goals.
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De-Risking The Unknown: Optimizing Statistical Design For Clinical Strategy
5/3/2021
What if Governance Board meetings began with hundreds of potential clinical trial designs presented to decision-makers in an easy to visualize way? In this webinar Dr. Yannis Jemiai, Cytel’s Chief Scientific Officer, will answer that question along with a few other and share a solution for achieving clinical trial success.
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Wearables-Based Clinical Trials: The Biostats And Clinical Overview Of A Growing Clinical Development Strategy
4/23/2021
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected changes to the industry ushered in by the COVID-19 pandemic has highlighted the need for remote monitoring and patient-centric outcomes and accelerated the changes in the trials conduct. In this blog we identify six elements critical to integrating wearables into your clinical development program.
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New Dimensions Of Clinical Trial Optimization
4/23/2021
The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options?
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Computing & Statistics: Are You Ready For The Industry Transformation?
4/5/2021
Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics, computational biology, cryo-electron microscopy, and numerous others forms of scanning, sequencing, and simulation. Yet there have been few reports of how computational power can affect the design and operations of clinical trials. Learn how revolutions in computing are now set to transform clinical studies, and how sponsors can remain competitive in this modern industry terrain by learning to harness the power of new technology.
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Aligning Commercial Strategy And Statistical Design
3/31/2021
Da Volterra wanted to maximize the power of their clinical trial for scenarios with a smaller treatment effect, and were contemplating a Sample Size Re-estimation design. Unfortunately, with a strict enrollment limit of 1,100 patients, this particular study design produced only marginal gains in power over the fixed sample size design. By working with Cytel’s statistical consultants and their powerful new software platform Solara, Da Volterra was able to maximize the chance of a successful trial result with precise insight into the tradeoffs in speed, savings and success with a simple, low-risk trial design identified within hours.