The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater collaboration between researchers, policymakers, clinicians, journalists, philanthropists, and other critical stakeholders. Funded in part by The Bill and Melinda Gates Foundation, a leader in global health solutions, this live dashboard offers an overview of all the clinical trials taking place in the international effort to tackle the pandemic.
We have been posting regular updates on the clinical development of COVID-19 therapy and vaccines, on Cytel’s Blog page. The following details are based on an updated data search accessed on January 11.
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 Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation for statistical excellence and our track-record of bringing innovative analytic approaches to the development of medicines for human health. In this blog, we ask Yannis for his favorite Cytel events from 2020.
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.
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.
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created by an independent Statistical Data Analysis Center (SDAC) using interim data from ongoing studies. The role of the DMC is to make recommendations about the continuation of the studies based on their best judgment and sometimes specified guidelines.
The DMC typically includes at least one statistician who votes on the decision to recommend stopping, modifying, or continuing a study. The SDAC typically is represented by at least one independent statistician and these statisticians are intermediaries between the sponsor and the DMC. The SDAC independent statisticians facilitate the efforts of the DMC by preparing and presenting summary data, taking care of meeting logistics, etc. These SDAC statisticians need ‘hard skills’ such as expertise in biostatistics, experience with clinical trial data, and knowledge of the study protocol. But it is essential that these SDAC statisticians also have the ‘soft skills’ for this role. In this blog, we highlight 10 key qualifications for these SDAC independent statisticians that are less technical, but no less essential.
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.
In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for a single arm trial. This potentially works for regulatory purposes (EMA/FDA). However, if they go to the local HTA authorities (NICE/CADTH), they will have to answer the question on the relative effectiveness of the new product compared to the standard of care in that country, and then its cost-effectiveness. Hence, typically, a manufacturer will identify a publication on a trial or real-world evidence on standard of care, or perhaps collect individual patient level data in clinical practice. Subsequently, it will conduct comparative effectiveness analyses for HTA purposes, a naïve comparison or an unanchored MAIC/STC/PSM of the single arm trial compared with the control arm.