Challenges and Implemented Solutions for the Oral Cleft Prevention Trial in Brazil

The Oral Cleft Prevention Program (OCPP) is a double-blind, randomized, two-arm multi-site clinical trial designed to assess the effect of periconceptional daily folic acid supplementation (4.0 mg vs. 0.4 mg) on the recurrence of cleft lip, with or without cleft palate, among women with elevated risk. Conducted in seven sites in Brazil, the OCPP randomized 2,510 women in the trial (1,257 to the 4.0 mg group, and 1,253 to the 0.4 mg group). A Data Coordinating Center (DCC), located in the United States, is responsible for the trial's statistical design and analysis, data collection system, data management and storage, activity coordination, data quality control, and site training. DCCs of international trials, such as the OCPP, face unique implementation challenges due to de-centralized organization. The objective of this paper is to describe these challenges and to present the innovative solutions developed to address them.