Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials: a qualitative descriptive study.

ABSTRACT:

Introduction

A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the extent to which the structure, membership and deliberations of DMCs enable them to address ethical issues.

Methods

We conducted qualitative individual interviews (n=22) with DMC members from countries across Africa, the Americas, South Asia and the UK. We selected interview respondents through purposive sampling, managed data using NVivo (Release V.1.7) and analysed data thematically.

Results

All respondents were highly experienced professionals; many (18/22) had received training in medicine and/or statistics. One respondent had acade

SUBMITTER: Hinga A 

PROVIDER: S-EPMC11404254 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature