Study conduct, monitoring and data management in a trinational trial: the OPTIMA model.
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.
Kyriakides
Tassos C
TC
VA Cooperative Studies Program Coordinating Center, West Haven, CT, USA. tassos.kyriakides@yale.edu
Babiker
Abdel
A
Singer
Joel
J
Piaseczny
Mirek
M
Russo
John
J
D044966:Anti-Retroviral Agents; D002170:Canada; D026661:Clinical Trials Data Monitoring Committees; D003299:Cooperative Behavior; D003628:Database Management Systems / Q000458:organization & administration*; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007391:International Cooperation; D017146:Models, Organizational; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D006113:United Kingdom; D014481:United States
D044966:Anti-Retroviral Agents