The Inevitability and Ethics of Inaccurate Screening in Clinical Trials: A Call for Research and Guidance

Abstract

Accurate screening of potential research participants is vital to ensuring the scientific, regulatory, and ethical appropriateness of clinical trials. Yet there are no definitive screening tests for many conditions, and many screening tests, even when implemented correctly, yield some inaccurate results. Sponsors, researchers, and review committees thus routinely face the question of when it is acceptable to approve and conduct clinical trials that rely on screening measures that are known to exclude some eligible individuals and to include some ineligible ones. This article calls attention to and proposes preliminary guidance to address this important issue.