On Friday, Oct. 11, Rob Ellis and Chris Benko of Koneksa were invited to present Research Rounds at the FDA for the Oncology Center of Excellence (OCE), the Office of Hematology and Oncology Products (OHOP), and the Office of Clinical Pharmacology (OCP):
OCE/OHOP Seminar: Using Wearables and Patient-Reported Outcomes (PRO) to Assess Functional Status: Use Cases and Potential Applications in Oncology
OCP Seminar: Digital Biomarkers to Improve Signal Detection in Patient Performance Outcome Assessment
With the FDA, Rob and Chris discussed Koneksa’s work in study design, remote biometric devices and electronic clinical outcome assessments, real-time data monitoring, and data analysis - and how this work is changing the shape of clinical trials.
Moreover, they were able to compare notes with FDA teams on the exciting and challenging facets of our work - everything from managing the collaboration between PRO experts and those who assess other types of assays, to assessing concordance between objective measures and patient sentiment.
The OCP seminar was a working discussion on algorithm development and disease models. The Research Rounds session was more broadly focused on our work and future direction in oncology and is available here: https://www.koneksahealth.com/ocepresentation/
We were honored to have an opportunity to converse with FDA researchers, learn from their points of view and share our perspectives.