Data quality in an HIV vaccine efficacy clinical trial in South Africa: through natural disasters and with discipline.

ABSTRACT:

Background

To produce quality data that informs valid clinical trial results and withstands regulatory inspection, trial sites should adhere to many complex and dynamic requirements. Understanding non-conformance to requirements informs the emerging field of improvement science. We describe protocol deviations in South Africa's largest HIV vaccine efficacy trial.

Methods

We analysed data from the HVTN 702 trial using mixed methods. We obtained descriptive statistics, from protocol deviation case report forms collected from 2016-2022, of deviation by participant, trial site, and time to site awareness. We thematically analysed text narratives of deviation descriptions, corrective and preventive actions, generating categories, codes and themes which emerged from the data.

R

SUBMITTER: Laher F 

PROVIDER: S-EPMC10290289 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature