• Cytel and its collaborators have analyzed the challenges of conducting high-quality clinical research in LMICs – a critical barrier to improved global health
• Their findings show that new, innovative clinical trial designs and statistical methods can effectively overcome these challenges
• The work has been published in a Series of articles in The Lancet Global Health
• The authors are calling for urgent mobilization of these new statistical approaches for better global health outcomes

Cytel’s biostatisticians have evaluated the difficulties of conducting randomized control trials (RCTs) in low- and middle-income countries (LMICs), and have revealed the power of new, innovative statistical methods to overcome the most pressing challenges in global health research. The findings were published in The Lancet Global Health, where Cytel and an international network of collaborators argue for urgent adoption of a range of clinical trial design innovations for improvements to global health. Despite their profound benefits, particularly in low-resource settings, such innovative methods have been consistently underutilized in LMICs. This new Series in The Lancet is the latest of Cytel’s efforts to propel fruitful international discussion and overcome hesitancy around the implementation of innovative statistical methods in clinical research.

Despite the growing international focus on public health, LMICs continue to suffer from a disproportionate burden of disease, stunting their economic development and hindering progress towards global sustainability objectives. A lack of adequately planned and sufficiently powered clinical trials tailored to suit the specific needs of LMICs has been a critical roadblock to gathering the robust data needed for improved healthcare outcomes in these regions.

However, over the last few decades a range of statistical innovations in clinical trial design and simulation have emerged. These innovations, which include Bayesian methods, master protocol trials, and powerful microsimulations, are uniquely equipped to tackle critical research challenges in LMICs, including resource scarcity and significant uncertainty around target diseases. Leveraging these methods, though, requires an alliance of deep biostatistical expertise and powerful technologies that can overcome the well-known computational barriers to their adoption.

“Our work over the last three decades has seen innovative designs and statistical methods – such as platform, basket, and umbrella trials, and powerful real-world analytics – reshape clinical development,” said Yannis Jemiai, Chief Scientific Officer at Cytel. “The natural extension of this is to encourage wider and faster adoption of these methods in low- and middle-income countries to help generate the improved healthcare outcomes they deserve. We hope our continued work in this space, most recently the publication of our new Series in The Lancet, will empower deeper consideration of these innovative statistical methods, and erode hesitancy to their use.”

One of the most promising recent trial design innovations is the adaptive platform trial, which enables the simultaneous evaluation of multiple therapies, even across disparate geographic regions, through standardized protocols. Platform trials can also accommodate the addition of new potential treatments to a trial that is already underway. The resultant operational efficiencies make these trials ideally suited to resource-scarce settings.

With the expertise in both Bayesian and frequentist methods needed for the design and analysis of platform trials, Cytel has spearheaded advancement of this approach, not least through a series of insightful webinars, peer-reviewed articles in high-profile journals, and by recently appointing renowned platform trial expert Dr Kyle Wathen as VP of Scientific Strategy and Innovation.

Radek Wasiak, Chief Data Officer at Cytel, who oversees the company’s work in global health, added, “We see our work as bridging the gap between high-income countries and low- and middle-income countries in terms of clinical trial execution. Through adaptive platform trials and other innovative designs, we can now test innovative technologies with consistent standards across the world.”

To find out more about how Cytel is leading the charge in statistical innovation for global health, please visit: https://www.cytel.com/master-protocols

About Cytel
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,500 employees across North America, Europe and Asia. For more information about Cytel, please visit us at www.cytel.com.