Traditionally, clinical trials are expensive, long in duration, and have low success rate. But with the advent of rich and abundant data, development teams can now optimize decision-making by integrating quantitative modeling approaches in their study strategy and planning. These approaches have become necessary to strengthen regulatory submissions, demonstrate competitive effectiveness, and reveal the full value of your product. Additionally, innovative trial designs can play a key role to improve the speed, savings, and probability of success of your clinical trials.
In a recent webinar, Cytel’s Chief Scientific Officer Yannis Jemiai illustrates how quantitative sciences play a critical role in a product team’s ability to make optimal decisions, earning the statistician a place at the strategic development table.
Why you need to abandon the traditional approaches to study design:
Over the past decade, the biostatistics community has made several advancements in mathematical methodologies supporting efficient clinical trial design. Yet, many companies continue to deploy traditional trial design techniques and thereby, miss opportunities to optimize their clinical trials.
Clinical trials with complex advanced innovative designs use adaptive methods, Bayesian methods and other novel clinical trial design techniques to increase efficiency and reduce costs. These adaptive designs allow you to re-evaluate the accuracy of your assumptions and decisions as data accumulate during the trial. However, the design and implementation of an adaptive trial requires skilled statisticians who can identify when an adaptation is most like to facilitate their goals . For example, a well-designed promising zone trial can help to manage resources and power a trial. A multiarm trial can facilitate population enrichment, and single arm studies are ideal for rare diseases.
Cytel East® provides its users easy access to rapidly generate multiple fixed, group sequential, Bayesian and adaptive designs. With East, our clients can build robust reference designs across a wide range of therapeutic areas and endpoints, across all phases of clinical trials, and can explore innovative trial designs with confidence. In the webinar, Yannis demonstrates how to design a group sequential and adaptive sample size re-estimation design in East. He uses an example trial design in CNS disorder; the primary outcome being measured is the change from baseline in HAM-A score. For this trial, the target average power is 90% with a standard Type-1 error (1-sided) of 0.025. The objective is to find the required sample size to ensure desired power, among other things. Yannis further edits the inputs to show how East helps statisticians quickly and easily explore adaptation options for their study design .
Digital Development Tool for Clinical Trial Design
As the number of innovative trial designs grow, the specific adaptations suitable for a trial will warrant tactical deliberation on necessary tradeoffs between timelines, resources, upfront costs, and study power. Every statistical design provides a specific measure for each of these parameters. However, using a powerful simulation and forecasting technology like Cytel’s Solara® can produce thousands or millions of trial designs and environmental scenarios. In such a scenario, evaluating every single design on a case-by-case basis cannot be an option. Solara helps the statisticians and the wider product development team understand strategic priorities and trade-offs in the broader design space. During the webinar, Yannis demonstrates how Solara can provide clarity and scale for your options, and help you confidently select designs that are optimal for the entire relevant design space.
Watch the on-demand webinar to learn more.
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has over 12 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Senior Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.