The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog saw a lot of activity as we tried to keep our readers abreast with the latest updates on the COVID-19 clinical trials, and covered other trending and important topics such as, the growing adoption of Synthetic Control Arms, master protocols, Head to Head Comparisons and Bayesian methods. We also collaborated with several experts from both within and outside the company to conduct several series of webinars and provided summaries through our blogs.
Continue reading to learn about the top 10 Cytel blogs that resonated most with our community in 2020.
As we prepare to close the door on 2020, we asked Pantelis Vlachos, Principal/Strategic Consultant for Cytel, to share his favorite Cytel events of this year. Continue reading this blog for a summary of Cytel’s 2020 contributions around adaptive designs and Bayesian methods.
When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given the parameters of their clinical study, they usually begin with five or six possible design options and begin to explore the most promising ones. The likelihood is that none of these trials will be optimal designs. Rather, they meet certain criteria that are “good enough” at which point, clinical development teams might begin to lead one way or another.
As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel discovered that a specific combination of process changes and technological advances has the potential to increase clinical development productivity by 10-20%. The Framework summarizes these as Thoroughly Explore, Decide Together and Communicate Tradeoffs. Here are 7 key features of this improved strategic framework. Alternatively, watch the webinar of our Chief Scientific Officer Yannis Jemiai discussing this Advanced Design Framework.
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing
The need for Re-imagining Clinical Trials: A recent survey conducted by Cytel found that only 42% of respondents reported using any complex or innovative clinical trial designs beyond the familiar group sequential approach. Although regulators respond quite favorably to such designs, sponsors have remained hesitant to use them.
A combination of technological and process advances are necessary to overcome mechanisms that contribute to stagnating statistical innovation in clinical development. Cytel responded by creating this new whitepaper that provides a new strategic framework that can help Clinical Development teams leverage cloud-computing and begin to initiate process changes, necessary to increase development productivity by 10-20%.
Significant advances have been made to enhance the efficiency of clinical trial designs. However, the traditional methods deployed by many pharmaceutical companies are fraught with challenges. Much less consideration is given to the value of decisions in the context of development programs or portfolios.
Cytel recently launched the “C-Suite Webinar Series”, an online initiative to help pharmaceutical executives drive commercial success with strategic insight from statistics. As a part of this series, Zoran Antonijevic, Head of Biometrics at MedSource, conducted a webinar where he describes methods for maximizing the value of programs and portfolios. This event was attended by numerous biopharma leaders.
Continue reading this blog to understand the concepts of program and portfolio optimization and learn about the benefits and opportunities presented by them.
The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago. Thanks to the advent of cloud-computing and advances in simulation technology, sponsors can now design hundreds of thousands of clinical trials in less than an hour. Yet how do we choose amongst all of these myriad options in a way that optimizes commercial prospects? Cytel’s Chief Scientific Officer sits down with us to discuss the Re-imagined Clinical Trial.
MUCE is a Bayesian solution for cohort expansion trials where multiple dose(s) and multiple indication(s) are tested in parallel. Such methods are particularly important for areas like oncology where several doses and several indications must be tested for successful completion of early phase trials, and optimal choice of dose and population to move on from early phase to a reasonable dosage for Phase 3.
Note that for these situations the number of comparator arms for a trial can increase rather rapidly. Testing three doses with three indications essentially requires 9 different trials. An efficient way to test a higher number of trials is therefore necessary for accelerated clinical development.
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago, it would take a statistician perhaps two or three days to design five clinical trial designs, a well-resourced statistician can now simulate and model well over 100,000 designs in less than 30 minutes. How does this affect the process of designing clinical trials
According to Yannis Jemiai, Chief Scientific Officer at Cytel, a combination of technology and process changes can establish the foundation for significant increases in productivity. Yannis argues that uncertainty should not be viewed as a challenge but an opportunity. Using statisticians strategically as well as tactically throughout the design process can help R&D teams drive commercial value for greater speed, savings and success.