An analysis of controlled human infection studies registered on ClinicalTrials.gov.

ABSTRACT:

Objectives

Controlled human infection studies (CHIS) involve intentional exposure of human volunteers to infectious agents. A previous systematic review found that adverse event (AE) reporting across CHIS is inconsistent, which makes data aggregation and reuse difficult. We hypothesised that data may be more easily aggregated using a clinical trial registry such as ClinicalTrals.gov, the largest publicly accessible registry of clinical trial data. The objectives of the current analysis were to (1) evaluate the use of ClinicalTrials.gov for CHIS data reporting and (2) compare CHIS clinical trial participant flow and AE reporting in ClinicalTrials.gov with the same data in corresponding published articles.

Design

ClinicalTrials.gov records that described a CHIS were included a

SUBMITTER: Toomey D 

PROVIDER: S-EPMC11808890 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature