The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
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.
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR community. Cytel and Ingress Health, now a Cytel company, contributed to a range of events including interactive workshops, issue panels, on demand podium presentations and virtual poster presentations.
Continue reading for discussions on tracking COVID-19 trials, reflecting on the successes, opportunities and failures of real world solutions, and bridging the gap between real world data and clinical development.
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.
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020, on November 16th – November 19th. Our Real-World analytics teams will be collaborating to deliver a number of interactive workshops, issue panels, posters and podiums to showcase their work and share innovative insights in HEOR, evidence generation, knowledge synthesis and decision analysis.
Click below to download our full list of sessions at ISPOR EUROPE and feel free to share this brochure with any colleagues who may find our sessions insightful.