RWE Archives - Medical Design Sourcing

RWE tips from Boston Scientific Peripheral Interventions CMO Dr. Michael Jaff

Dr. Michael Jaff is chief medical officer and VP of the Boston Scientific Peripheral Interventions business. [Photo courtesy of Boston Scientific]

Real-world evidence (RWE) is a transformational concept for medical device design and engineering, says Dr. Michael Jaff, the chief medical officer and VP of the Boston Scientific Peripheral Interventions business.

“Every really great technological advancement in the vascular space has come from a physician’s recognition that they would like to be able to do something safely and effectively for their patients, but the technology does not exist,” Jaff said in an interview with Medical Design & Outsourcing. “They find their way to an engineer, someone really smart takes that concept builds a prototype — off to the races. And it has time and time again transformed the way patients can be cared for.”

RWE leverages modern data coll…

J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

How real-world evidence can augment clinical trial data

Photo by Joshua Sortino on Unsplash

The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from patients participating in these site-based studies would be analyzed to evaluate the suitability of a medical product for commercial release.

However, the exponential increase in patient data recorded by digital devices in recent years has introduced to trial sponsors and researchers the possibility that real-world data (RWD) and real-world evidence (RWE) may be used to augment data from a clinical trial.

While RWD and RWE often are conflated, they are not the same. As the FDA explains, “Real-world data are the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources.” RWD can come from multiple sources, including electronic health record…

Using real-world evidence in clinical trials: Challenges and opportunities

Photo by Joshua Sortino on Unsplash

The healthcare industry traditionally has used site-based clinical trials to assess the efficacy and safety of drugs and medical devices. Data collected from participants in these trials would be evaluated to determine whether the product in question should be approved for commercial use.

In recent years, however, the exponential increase in patient data recorded by digital devices has raised the possibility that real-world data (RWD) and real-world evidence (RWE) may be used to augment clinical trial data.

But what are RWD and RWE? Are they the same thing? And how could they effectively be integrated into clinical trials to produce better outcomes for consumers?

Here’s how the FDA defines RWD and RWE:

Real-world data relate to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. RWD can come from mul…

Ethics matter when deploying RWD and RWE

Image courtesy of FDA

Because adoption of real-world data (RWD) and real-world evidence (RWE) remains at an early stage, individual biopharma executives are likely to take on a central role in ensuring that such data — and the related use of AI — are handled ethically. It becomes imperative that drug developers using RWD ensure transparency, apply consistent rules, peer reviews and develop best practices when dealing with biased research data.

The ethical dimensions of RWD are poised to “become a much bigger topic of conversation,” said Jeff Elton, CEO of ConcertAI, which just hauled in $150 million in Series C funding.

That said, FDA has released a series of guidance documents related to RWD and RWE in recent years with some recommendations for dealing with incomplete data. In essence, the agency stressed studying the representativeness of RWD and, if it is not fully representative of a t…

What’s really happening with clinical trial innovation?

Image courtesy of Pixabay

The clinical trial landscape has evolved significantly in the past two years. But given the quick embrace of decentralized clinical trials and growing traction of apps, digital health and other technologies in the space, it can be difficult to separate hype from reality.

To learn more about the evolving landscape, we caught up with Libbi Rickenbacher, director of strategy at 4G Clinical, to discuss the ongoing impact of the pandemic, decentralized clinical trials and other relevant trends.

Radical shifts in clinical trials?

The pandemic has undoubtedly disrupted clinical trials, leading to delays and outright cancellation of scores of studies. It may seem like a radical shift, but there was also self-preservation at work, Rickenbacher said.

“For some of those studies, maybe it was better for them to cancel,” she said. “It was very unfortunate for the patients, but you …

Why RWD and RWE are poised to continue gaining ground in 2022

Image courtesy of Wikimedia Commons

While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market.

“We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,” said Jeff Elton, CEO of ConcertAI. “That was not the case three or four years ago. That’s a pretty fast transition.”

It also helps that the FDA has also sharpened its focus on RWD and RWE. For example, late last year, the agency published proposed guidance related to data standards for product submissions with RWD. The agency also weighed in on the use of RWD and RWE to support regulatory decision-making for drugs and biological products with specific advice for data from electronic h…

Building a new foundation for oncology clinical trials

Photo by Anna Shvets from Pexels

The COVID-19 pandemic disrupted oncology clinical trials, and drug developers and regulators, including the FDA, continue to look for ways to catalyze clinical trial innovation. The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.

One factor contributing to the evolution of oncology clinical trials is the change in interactions between sponsors and regulatory agencies. “It is materially diffe…

The COVID-19 effect: Research platforms require new capabilities

Photo by Chris Liverani on Unsplash

Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact.

The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March. With safety concerns a top priority, the FDA encouraged researchers to consider alternatives for patient assessments and data collection, including virtual visits. Since elements of the DCT model (full or hybrid) enable patient participation from their homes and can be integrated into any clinical trial, DCTs are fast becoming the new normal. The increasing utility and acceptance of real-world data. Real-world data (RWD) refers to data relating to patient health status and/or the …