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Dr. Kyle Wathen talks to Outsourcing-Pharma on the Need for Statistical Innovation

The COVID-19 pandemic elevated the challenge of designing and executing clinical trials within a substantially shortened time frame, and with limited data. It was incredible to see how the industry still came together to bring several effective vaccines to the market. One of the factors behind this success is the adoption of innovative technologies that helped sponsors overcome the time and resource challenges.

In an interview with Outsourcing-Pharma, Dr. Kyle Wathen, Vice President of Scientific Strategy and Innovation at Cytel, explains the need for statistical innovation to improve clinical research across the world. The pandemic led many organizations to drop the tried and tested traditional techniques and explore novel designs and statistical methods.

For example, Bayesian statistics played a transformational role in quality vaccines being quickly identified and assessed. Bayesian methods offer an intuitive approach to clinical development, maximizing the use of available information at each interim analysis. For fast recruiting trials, Bayesian designs offer higher confidence in early futility, efficacy and sample size decision making, basing the decision on the consistency of the results from two or more early interim analyses.

However, the complexity of innovative designs has always been a hindrance in its widespread adoption. Time and technical constraints made it impractical for companies to investigate novel designs and even discover the optimal trial design. But with the emergence of cloud-powered trial optimization capabilities, companies can now generate and compare millions of simulations and designs. For example, Cytel’s Solara is a trial strategy platform that combines massive cloud compute with Cytel algorithms to generate an expansive range of models for development teams to consider. It also provides a collaborative workspace for cross-functional discussions during trial selection.

Adaptive platform trial approach is another statistical innovation that helped during the pandemic. These trials offer the much-needed flexibility when so much is unknown, without sacrificing the scientific rigor. In adaptive platform trials, multiple treatments can be simultaneously tested, arms can be added as new candidate treatments emerge, and arms can be dropped as candidate treatments are found to be ineffective or harmful. In the interview with Outsourcing-Pharma, Dr. Wathen talks about the benefits of this approach.

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About the Author of Blog:

Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.