Doing randomized controlled trials in a developing country: some practical realities.

Abstract

BACKGROUND: Formal randomized controlled trial results are often reported. The difficulties of doing such trial are not. Developing countries represent a new field in which trials can be undertaken. In this context even less is known about the practicalities involved. METHOD AND RESULTS: A randomized, double-blind, parallel study took significantly longer than expected to complete and subject recruitment and participation fell short of expectations. Different recruitment strategies were used and these performed differently in terms of enrolling trialists. Subjects most frequently left the trial in its early stages. CONCLUSIONS: Possible explanations for these findings include the demography of the country, cultural factors, and the existence of an established doctor-patient relationship.