AdvaMed will be hosting a free Virtual Medical Devices and Diagnostics Statistical Issues Poster Session on April 23 at 1:00 pm ET. This event consists of three industry experts presenting topics that address some of the latest statistical trends and issues facing medtech organizations. The presentations were originally submitted for the Poster Session at the 2020 Medical Devices and Diagnostics Statistical Issues Conference. We are excited to have the opportunity to showcase these presentations virtually.
Featured Speakers & Topics:
Clustered Survival Data in Multi-Site Single-Arm Clinical Studies
Guy Cafri, PhD, MStat
Performance of an implantable medical device often has variability across surgeons/sites (clusters). Standard error estimates for survivorship outcomes in multi-site single-arm studies often assume subject outcome independence. The purpose of this presentation is to empirically evaluate the performance of survivorship standard error estimates through Monte Carlo simulation: conventional (Greenwood), cluster bootstrap and robust standard error approach.
Five-Year Results of Paclitaxel-Coated Balloons and Stents: A Propensity Score Matched Case Control Study
Sapan S. Desai, MD, PhD, MBA, FACS
Recent studies have found that paclitaxel drug-coated balloons (DCBs) and stents (DESs) are associated with increased mortality compared to routine angioplasty and stenting. This study evaluates long-term outcomes of paclitaxel devices for the management of femoropopliteal peripheral artery disease (PAD) using real world evidence derived from a large international registry. Based off an analysis of 11,710 patients who received a paclitaxel device, we found that paclitaxel DCBs and DESs are associated with improved limb salvage rates and a survival advantage compared to routine angioplasty and stenting for PAD patients, especially in those with CLI.
Analytical Performance Acceptance Criteria for CDx in Bridging Studies
Shuguang Huang, PhD
One of the common challenging questions faced in CDx bridging studies is how to determine the acceptance criteria for analytical performances. For example, what level of concordance (PPA, NPA) is good enough? FDA typically request reporting the lower bound of the 95% CI, yet it is often a ‘tug-of-war’ between the sponsor and the regulatory agency in specifying the acceptance limit. This research focuses on the analytical concordance between the CTA (clinical trial assay) and MRA (market ready assay, aka CDx) in a bridging study.