Increasing protocol suitability for clinical trials in sub-Saharan Africa: a mixed methods study.

ABSTRACT:

Background

The trial protocol is the most important document for clinical trials and describes not only the design and methodology of a study, but also all practical aspects. The suitability of the protocol has a direct impact on the execution and results of the trial. However, suitability is rarely addressed in trial practice and research. The aim of our study was to investigate protocol suitability and to identify suitability-enhancing measures for trials in sub-Saharan Africa.

Methods

We used an exploratory mixed methods design. First, we interviewed 36 trial staff at different organisational levels in Ghana, Burkina Faso and Senegal. Second, we conducted an online survey among trial staff in sub-Saharan Africa to investigate trial protocol suitability based on the main t

SUBMITTER: Vischer N 

PROVIDER: S-EPMC5683382 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature