real-world evidence Archives - Medical Design Sourcing

Why linking clinical trials to real-world data is the critical next step for medical device development

Connecting medical device clinical trials to real-world data (RWD) helps demonstrate efficacy, safety and cost-effectiveness.

Mehdi NajafZadeh, Medidata

Medical device and diagnostics manufacturers need to build data linkage into their clinical trial planning today to remove silos and mobilize efficient use of data sources for better clinical evidence generation in the years to come.[Illustration via Adobe Stock]

Medical device and diagnostics manufacturers face mounting pressure from regulators, payors and providers to provide more holistic evidence to demonstrate the efficacy, safety, and cost-effectiveness of their products.

To address these increasing requirements — as well as accelerate study timelines and reduce clinical trial burden — medical device sponsors are seeking innovative solutions. Connecting clinical trials to real-world data (RWD) is an effective approach to capture the information nee…

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…

How synthetic data accelerates oncology research and drug development

[MDSHAFIQUL/Adobe Stock]

Synthetic data in oncology is transforming how researchers and developers approach real-world evidence. They often need this evidence to test hypotheses, predict outcomes and develop algorithms. But privacy constraints and access related to patient data can create delays and lengthen project timelines.

Oncology drug researchers and developers have recently begun using synthetic data in oncology to get around the privacy constraints and access issues related to patient data that create delays and lengthen project timelines.

Conceptually, synthetic data in oncology is about taking private patient information and enabling researchers to access the data without compromising privacy, offering a significant tool for current oncology research processes.

Traditional vs. new data approaches in oncology research

Traditionally, oncology researchers and drug developers have relied on t…

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…

PathAI launches AISight digital pathology platform and NSCLC algorithm

PathAI has launched a new digital pathology platform, AISight. Supporting AI-driven research, the digital pathology platform was trained on a real-world dataset of over 5,000 samples with inputs from more than 350,000 cell and tissue-level annotations from more than 50 pathologists. The company has also released its AIM-PD-L1 NSCLC RUO algorithm, which calculates the percentage of PD-L1 positive tumor and immune cells in NSCLC samples. The AIM-PD-L1 NSCLC RUO algorithm calculates the percentage of PD-L1 positive tumor and immune cells in NSCLC samples over the entire slide image (WSI).

Validating the AIM-PD-L1 NSCLC algorithm

PathAI previously shared validation data for the AIM-PD-L1 NSCLC algorithm at the AACR Annual Meeting in 2022. The AISight Early Access Network laboratories will build on this work by testing the algorithm’s performance on real-world data. Other IHC quantitation algorithms for various types of cancer are also available to these labs. PathAI…

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…

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…