The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of the potential effects of these changes is the more strategic use of real world evidence to support evidence generation for regulatory approval of clinical trials.
Dr. Radek Wasiak, Chief Data Officer at Cytel and Sreeram V Ramagopalan, Roche, recently co-authored a publication in the Journal of Comparative Effectiveness Research (JCER) on this likely development. The mix of delayed trials, missing data, and other challenges to traditional statistical design has meant that new tactics need to be deployed to salvage otherwise critical trials.
Outlining the true potential of RWE made Dr. Wasiak’s article one of JCER’s top ten most widely read in 2020.
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.
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.
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.
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on quantitative strategy are spotted more quickly. Statisticians can determine whether datasets can strengthen study findings by being presented in a way that uses the available data in a scientifically objective way that is at the same time in line with the clients’ strategic objectives.
The practice of combining statistical needs with the processes of data management and other related services for real world evidence, we will henceforth call RWE-Delivery. There are several models for RWE-delivery that can similarly vary with the needs of a study. Questions about process, management and timelines are just as key for this choice of delivery model, as the objectives of the delivery. Therefore, it is important to work closely with delivery teams to determine the possible needs for study completion.
In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company). Bart provides us insights on the trends in HEOR and explains why Bayesian methods are also important for Health Economics. Read Part 1 here.
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his background and experience in Health Economics, understand the important considerations of real-world evidence studies and the impact of COVID-19 pandemic on the work of the health economics outcomes researchers who work at Ingress and Cytel. We also cover important HEOR topics such as its benefits for market access studies and real-world analytics (RWA) for regulatory submission.
Cytel and Ingress-Health will be contributing to a range of events at Virtual ISPOR EU 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 EU