DOING RANDOMIZED CONTROLLED TRIALS IN A DEVELOPING-COUNTRY - SOME PRACTICAL REALITIES

Background. Formal randomized controlled trial results are often repor ted. The difficulties of doing such trials are not. Developing countri es represent a new field in which trials can be undertaken. In this co ntext even less is known about the practicalities involved. Method and results. A randomized, double-blind, parallel study took significantl y longer than expected to complete and subject recruitment and partici pation fell short of expectations. Different recruitment strategies we re used and these performed differently in terms of enrolling trialist s. Subjects most frequently left the trial in its early stages. Conclu sions. Possible explanations for these findings include the demography of the country, cultural factors, and the existence of an established doctor-patient relationship.