real-world evidence Archives - Medical Design Sourcing

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…