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

Clin Trials. 2004;1(3):277-81. doi: 10.1191/1740774504cn022oa.

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 country-specific 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.

MeSH terms

  • Anti-Retroviral Agents
  • Canada
  • Clinical Trials Data Monitoring Committees*
  • Cooperative Behavior
  • Database Management Systems / organization & administration*
  • HIV Infections / drug therapy
  • Humans
  • International Cooperation
  • Models, Organizational
  • Multicenter Studies as Topic / methods*
  • Multicenter Studies as Topic / statistics & numerical data
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • United Kingdom
  • United States

Substances

  • Anti-Retroviral Agents