Study conduct, monitoring and data management in a trinational trial: the OPTIMA model

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Abstract
The OPTions In Management with Antiretrovirals (OPTIMA) Trial, a collaboration between three governmental agencies in the USA, UK and Canada is a large-scale, multicenter, randomized controlled trial designed to compare the relative efficacy of different therapeutic strategies in HIV disease. The collaboration of three coordinating centers introduced unique data management issues including: a) use of different data systems for managing “country” trial data; b) two-way data transfer between the coordinating centers and the center where OPTIMA data is merged and analysis files are generated; and c) translation of certain data forms (mainly patient completed questionnaires) into French and Spanish. The involvement of three data centers provided a challenge in planning, designing and executing data management procedures in OPTIMA. Processes were implemented to ensure the trial's successful execution at the trinational level, without disregarding countryspecific requirements and regulations. The OPTIMA model required a significant time and resource investment on behalf of all agencies involved, but allowed for autonomy and a sense of joint ownership of data in different countries.