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Cytel and Ingress Health at Virtual ISPOR Europe 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.

The COVID-19 Trial Tracker- A Framework to Provide Real-Time Updates on Emerging Evidence
By Michael Zoratti, Director HEOR and Grace Hsu, Senior Statistician; Moderator: Kristian Thorlund, SVP, Real World Analytics

The workshop took attendees through the development of the COVID-19 Clinical Trial Tracker, a Cytel initiative sponsored by the Gates Foundation which tracks the evolution of COVID-19 trial results in real time. The discussion was on high-level considerations to guide the development of a useful evidence tracker. The presenters talked about Cytel’s trial tracker, the processes we established to collect and organize data, and how we got there. A broader discussion on the approach ensued.

The presentation covered applications of this framework to other contexts, such as tracking emerging evidence in trials or observational studies; or as a means of replacing or supplementing traditional technical report documents. The attendees also learned about the power of this application to visualize and disseminate complex information across a diverse audience with varying needs.

Senior Statistician Grace Hsu also spoke about the technical know-how one needs to be successful at launching such a device. She provided insights on the types of skillsets a team needs to have, but with an emphasis that neither strict programming backgrounds nor highly specialized skillsets are essential. She talked about how various factors should determine the team composition for such an endeavor, and how these can change throughout such a project—often a very small but dynamic team is adequate. Grace also explained the kinds of technical problems that came up, and how collaboration is key to success.

Issue Panel moderated by Kristian Thorlund: Reflecting on the Failures of Real World Data in COVID-19 – Should Global Health Learn from Oncology or Are the COVID-19 Real World Data Challenges Too Unique?

This Panel addressed the current shortcomings of real world studies in COVID-19 and how the experience and technologies already available in areas like oncology can ensure the feasibility, validity and relevance of future COVID-19 real world studies. Questions around the key challenges of logistics and data validity that currently exist, the technologies and processes that have or are being developed to resolve these issues and the realistic timelines, were addressed. The panel also discussed the appropriate balance between retrospective and prospective data collection, which technologies already exist for oncology Real World Data that have not adequately been utilized in COVID-19 and what are the major reasons for this?

Bridging the Gap Between Clinical Trials and Real World Data: Evidence on Replicability of Efficacy Results Using German Claims Data

While randomized controlled trials (RCTs) are considered the gold standard for estimating the efficacy of a treatment, the idea to use Real World Evidence (RWE) for both regulatory and HTA purposes is gaining momentum. Replicating RCTs using real-world data can help calibrate RWE against trials and shed some light on the opportunities and limitations of real-world studies. We sought to use claims data to mimic two oncology trials in prostate cancer. Real-world patients were substantially older and had a shorter median overall survival compared to patients in the trials. However, the relative survival advantages estimated in claims data were remarkably similar to those from the trials, suggesting no major effect modification and a potential to use RWE for Bayesian hierarchical NMA and measuring effectiveness in outcome-based reimbursement agreements.

This podium presentation is available to all attendees as an on demand session on the ISPOR website.

At Cytel, we generate evidence that complements traditional randomized clinical trials, accelerates submissions, expands indications and supports health-economic decision-making. We focus on using sophisticated statistical, decision modeling and data science techniques to generate evidence that regulators and payers will trust.

Click the button to watch a virtual panel discussion, which begins with challenges faced by clinicians and drug developers, followed by examples of tools and trial designs currently being used to help sponsors of COVID-19 trials.

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