Screen failure data in clinical trials: Are screening logs worth it?

ABSTRACT:

Background

Clinical trials frequently spend considerable effort to collect data on patients who were assessed for eligibility but not enrolled. The Consolidated Standards of Reporting Trials (CONSORT) guidelines' recommended flow diagram for randomized clinical trials reinforces the belief that the collection of screening data is a necessary and worthwhile endeavor. The rationale for collecting screening data includes scientific, trial management, and ethno-socio-cultural reasons.

Purpose

We posit that the cost of collecting screening data is not justified, in part due to inability to centrally monitor and verify the screening data in the same manner as other clinical trial data.

Methods

To illustrate the effort and site-to-site variability, we analyzed the screening

SUBMITTER: Elm JJ 

PROVIDER: S-EPMC4264995 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature