Abstract
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.
Highlights
Aa multisite data coordinating center (DCC) is typically involved in all stages of the trial, including planning and design, trial implementation, data collection, trial closeout, final analysis, and publications
Such trials face several special challenges not encountered in other trials, such as maintaining efficient communication between sites, facilitating collaboration between the Chakraborty, et al.: DCC for Oral Cleft Prevention Program in Brazil investigators, and dealing with cultural differences.[2]
The objective of this paper is to describe the Oral Cleft Prevention Program (OCPP) trial design; the challenges faced that have not been described inprevious literature; and the developed innovative solutions to these new challenges
Summary
Aa multisite data coordinating center (DCC) is typically involved in all stages of the trial, including planning and design, trial implementation, data collection, trial closeout, final analysis, and publications. When investigating less-common diseases, international multisite trials are often required to recruit an adequate sample of participants from each participating site.[1] Such trials face several special challenges not encountered in other trials, such as maintaining efficient communication between sites, facilitating collaboration between the Chakraborty, et al.: DCC for Oral Cleft Prevention Program in Brazil investigators, and dealing with cultural differences.[2] The DCC plays a major role in addressing these challenges and facilitating teamwork and cooperation between all of the study site institutions.[3] In addition, international multisite trials often face challenges that arise due to differences in regulatory structures, and research infrastructures, which add obstacles to the process of obtaining ethical approval for atrial and may significantly impact a study’s timeline. In countries where a national research ethics body exists, approvals for research with human subjects may need to be obtained from these institutions, in addition to local ethical committees at each trial site.[8]
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