Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our subject matter experts and blog authors shared their insights on industry trends and the various scientific innovations at Cytel. Here, we present the top 10 Cytel blogs that resonated most with our community in 2021.
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. An under-appreciated component of this change is the transformational role that Bayesian statistics has played in quality vaccines being quickly identified and assessed.
This blog offers a review of the statistical design of Bayesian COVID-19 vaccines trials for mRNA and BCG vaccines. Learn More.
Starting the Conversation Early: Incorporating Business Considerations in Optimal Selection of Trial Design
For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization.
In this blog, Cytel's Chief Scientific Officer Dr. Yannis Jemiai shares his insights on how the concept of Pareto optimality can be used by sponsors to focus clinical strategy discussions and begin the conversation about resource allocation and clinical trial optimization much earlier in the drug development process. Learn More.
Cytel’s Career Perspectives blog series features interviews with employees where they talk about their career path, achievements, current role, opinion on industry trends and offer career advice relevant to our field.
In 2021, we interviewed our diverse group of experts who have been pushing boundaries with their contributions:
“The Good Data Submission Doctor” is a blog series authored by Angelo Tinazzi, Senior Director, Statistical Programming at Cytel. In this blog, Angelo narrates his experience of taking the pilot CDISC certification exam and shares his views on its value. Read more.
Understanding Head-to-Head Clinical Trials
Two therapies are placed in head-to-head clinical studies when they are compared against each other as opposed to a standard of care. When multiple treatment options are available to patients, a head-to-head clinical trial can establish how well these treatments compare to each other. Learn More.
How to Ensure You Get Optimal Study Power for Your Investment in Time and Cost
Imagine a statistician who could take the specific nature of a sponsor’s study into account and present every single design that optimized power for a given investment of sponsor resources. Cytel’s new position paper shows sponsors how to partner with statisticians to achieve this set of optimized results for every single study. Read more.
The Benefits of Using Basket Studies in Oncology
Currently, there are many treatment options for Cancer such as, Immunotherapy, Radiation Therapy, Chemotherapy etc. If we were to investigate all these options for each indication, it can result in requiring several individual clinical trials. One way to address this is by conducting a Basket trial in which a targeted therapy is evaluated for multiple diseases that share common molecular alterations or risk factors that may help predict whether the patients will respond to the given therapy. In Oncology, an increasing number of biomarker-targeted therapies are now being investigated and approved. Read more.
Use of Rolling-enrollment Designs to Accelerate Clinical Trials
Cohort-based enrollment can slow down dose-finding trials and can also be inefficient, especially if the trial needs to be frequently suspended. To shorten the study duration of phase I trials and reduce the number of accrual suspensions, use of rolling-enrollment designs is recommended, which allows concurrent patient enrollment that is faster than cohort-base enrollment. Read more.
Keeping the Promise: Ten Year Anniversary of the Promising Zone Design
Ten years ago Cytel co-founder Professor Cyrus Mehta and Professor Stuart Pocock of the London School of Hygiene and Tropical Medicine, published Adaptive increase in sample size when interim results are promising: a practical guide with examples, the paper which first advanced the concept of the Promising Zone Design.
The design was meant to optimize clinical trials by using an interim look to determine whether a study was promising, and thereby to channel more resources towards it to ensure a good drug did not fail due to the trial being underpowered. This simple adaptation has had significant effect on the way strategically enhanced clinical trial design is now understood in the industry. Read more.
Leveraging Synthetic and External Control Arms Using Bayesian Methods
In recent times, Single arm trials are being increasingly used to assess new treatment interventions. They establish clinical benefit by demonstrating the effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, an alternative approach known as external controls or synthetic control arms (SCA) are being used that leverages real world data and historical datasets. Technical knowledge of Bayesian methods is key to being able to design and implement such trials. Read more.
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