The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
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.
As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his research on applying machine learning for predictive analysis and evidence generation.
The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data. Sophisticated machine learning (ML) and AI techniques allow us to access and analyze any combination of a multitude of data sources. The way that traditional controlled sources are viewed is being adapted in light of new evidence that emerges from real-world data. In his presentation, Alind introduces us to the concept of ML and Causal Inference and discusses case studies from randomized clinical trials and real-world data.
Click the button to register for the on demand webinar.
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
Upcoming Discussions: The Uniqueness of COVID-19 Real-World Data Challenges & The COVID-19 trial tracker
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety, statistical rigor, and speed has prompted the rapid surge in the generation of clinical data. However, this information is scattered across multiple platforms, making it challenging to measure comparative treatment effects across trials. Consequently, we are seeing a high frequency of failures, that diminishes the public’s confidence in research and slows the path from scientific results to action.
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic approaches. Companies need careful cost-effectiveness analyses for successful reimbursement submissions. In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company). Bart talks about his background in HEOR, founding Ingress Health and its recent acquisition by Cytel. He also talks about the benefits of turning to an HEOR specialist and provides a sneak peek into Cytel’s presentations at the upcoming ISPOR EU 2020 event.