The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
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.
Sachin Sobale began his career with Cytel as a young statistician. He has been associated with the company for more than 13 years and is now based in the US. In this blog we talk to Sachin about his journey so far, his current role, and achievements; and we get some tips from him for young statisticians who are interested in pursuing a career in this field.
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.
The Cytel COVID-19 Trial Tracker brings you an up to the minute, real time dashboard about COVID-19 trials around the world. This snapshot gives you a quick briefing on the current state of COVID-19 therapy and vaccines development.
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.
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As several entities develop curative and preventive responses against COVID-19, alignment with regulatory recommendations is key for developing effective and safe intervention. Moreover, fast regulatory approval will translate into early availability of interventions to address unmet needs.
Continue reading to get an overview of the registered COVID-19 clinical trials landscape, with a story on the special attention received by Hydroxychloroquine treatment.
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 Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all of us missing the face-to-face contact.
The conference kicked-off on Sunday night with a Social Virtual event with a “Numerologist Show”. Of course this could not replace and compete with the usual “toast” we were used to do live, so we did it virtually (check out my LinkedIn post where I offer some cocktails recommendations and share the recipe of my favorite cocktail “The Negroni” with a bit of history. But please don’t do it before Friday night, you will need the weekend to recover).
Like every year, Cytel significantly contributed to the event as one of the official sponsors, running a workshop (“Predictive Analytics Using R”), chairing and co-chairing two streams (Machine Learning & Connected Health and Scripts and Macros), preparing four on demand presentations (in Application and Development, Coding and Tricks and Data Standards and Governance streams) and two posters.
In this blog, I focus on presentations related to data standards and data submission to agency, in general.