Pilot project to answer where and how RWE can be used

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/ipopba)
(Image: Getty/ipopba)

Related tags: RWE, Real world evidence, Real world data, IQVIA

The Friends of Cancer Research, in collaboration with Iqvia and other health care research organizations, are working to determine where and when real-world data can be trusted.

Friends of Cancer Research (Friends) recently published initial findings from its real-world evidence (RWE) pilot project.

The findings, published in JCO Clinical Cancer Informatics​, demonstrate that real-world endpoints “are generally consistent with each other and with outcomes observed in randomized clinical trials, which substantiates the potential validity of real-world data to support regulatory and payer decision making,”​ per the report.

“Differences observed likely reflect true differences between real-world and protocol-driven practices,”​ concluded the paper authors, including Nancy Dreyer, chief scientific officer and senior vice president of real-world solutions at Iqvia, which joined the project in 2018 to evaluate the ability of real-world data to estimate real-world endpoints in lung cancer.

“Understanding the importance of demonstrating the validity of real-world evidence, particularly in oncology where there are so many unmet needs and complex treatments, Iqvia embraced this as an opportunity to validate the use of RWE as an efficient means to innovate drug approvals and to advance personalized medicine,”​ Dreyer told us.

While the initial project demonstrated the ability to extract several real-world endpoints from various datasets, the next phase aims to further characterize the role of these endpoints.

“The goal of the 2.0 pilot is to understand where and how RWE can be used to evaluate treatment effectiveness in lung cancer,”​ she explained.

Other participants include Aetion, the American Society of Clinical Oncology (ASCO), CancerLinQ, Cancer Research Network, Cota, the US Food and Drug Administration (FDA), Flatiron Health, Mayo Clinic, McKesson, NCI SEER-Medicare Linked Database​, OptumLabs, Syapse, and Tempus.

RWE: Where and when?

To implement the 21st Century Cures Act, the US Food and Drug Administration (FDA) “needs to know where and when real-world data can be trusted,” ​said Dreyer, adding that the regulator also needs to determine when one or more traditional randomized trials need to be conducted.

“As a by-product of this work, we are learning how RWE differs from evidence that comes from the idealized situations studied in traditional trials,”​ she said. “RWE is complementary to randomized clinical trials because the way patients are cared for in a trial is not the same as in routine care, and therefore the outcomes could be different as well.”

Next steps will involve characterizing the similarities and differences in data sources and their covered populations, explained Jennifer Christian, vice president, Center for Advanced Evidence Generation, Iqvia.

Iqvia will use randomized clinical trials (RCTs) as benchmarks for comparison to conduct sensitivity analyses, she told us, noting the need to evaluate the framework in other therapeutic areas and countries.

As part of this, Iqvia, in collaboration with Friends and Health Data Insight in the UK, also will use Public Health England’s Cancer Registration and Analysis Service to compare data from outside the US. 

Said Christian, “Although differences are expected, it will be useful to know what those differences are, and whether they are likely to be artifacts of data recording or meaningful differences in benefits and risks.” 

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 21-Sep-2020 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Covance Touchless Drug and Device Vigilance Vision

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Lessons Learned: Clinical Trials During a Pandemic

Lessons Learned: Clinical Trials During a Pandemic

PCM TRIALS | 01-Sep-2020 | Technical / White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that...

Related suppliers

Follow us

Products

View more

Webinars