Dr. Gregory Vidal Discusses Use of Patient Registries in Neratinib Study

Gregory Vidal, MD, PhD, of West Cancer Center and Research Institute, discusses the methodology of the Neat-HER study on neratinib in the extended adjuvant setting in HER2-positive breast cancer. The ongoing study, which uses a novel virtual patient registry with the potential to garner more real-world data than traditional registries, was presented at the 2020 San Antonio Breast Cancer Symposium.

Transcript

Neat-HER is using a virtual patient registry, a novel methodology. What are some potential benefits of designing studies with virtual registries?

Some of the main important, or unique, information that you can get is post-marketing detail. We know what the adverse events are on trial, but are there new adverse events that show up later on? [Data] about management of adverse events and how this is being done in the real world. Not only that, but how your drug is currently being used in the real world. Are there insurances with coverage and in the real world? [That is information] that we may not be able to garner through a study. Also, are there other factors in terms of which patient gets it, what are physicians’ practice patterns, and all of that sort of information you get through a post-marketing virtual registry that you would not otherwise have.

We’re excited about this trial. We hope we can increase enrollment. We hope folks seeing this can encourage physicians and encourage patients who are neratinib—which is the drug of interest here—being used in the extended adjuvant setting, to go in and register and provide some information.