Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 34 - Current and Future Challenges in Diagnostic Device Evaluation
Type: Topic Contributed
Date/Time: Monday, August 3, 2020 : 10:00 AM to 11:50 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #314030
Title: Designing Studies of Tests for Biomarkers Using Banked Specimens
Author(s): Alicia Toledano*
Companies: Biostatistics Consulting, LLC
Keywords: in vitro diagnostic test; specimen bank; bias; pooling

There is currently wide interest in evaluating in vitro diagnostic (IVD) tests of biomarkers. Applications of these IVDs include personalized medical management. In a screening setting, prevalence of a condition of interest (COI) is often 2% or less. This leads to important challenges in performing prospective studies of IVDs, for example, the effort and expense of enrolling a very large number of subjects without the COI in order to obtain enough subjects with the COI to adequately power statistical inference. One way to meet this challenge is to enroll all eligible subjects likely to have the COI, and limit the rate of enrollment of eligible subjects less likely to have the COI. A benefit of the wide interest in biomarkers is the existence of well-curated specimen banks. Using specimens from these banks can save time and money. However, care must be taken to ensure that the specimens are selected in a manner that mitigates biases, such as spectrum bias. One must also be able to justify using specimens provided to the bank from different prospective studies. This talk will discuss considerations related to subject selection and pooling specimens from multiple studies.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2020 program