Isolated cleft palate is the commonest craniofacial birth anomaly (e.g., 4.5 per 10,000 births in the US). It creates problems in feeding, speech, hearing, and dental development. Surgery may fail to resolve these problems and reduce the child's potential for social development and inclusion. The purpose of the "Timing of Primary Surgery for Cleft Palate" trial is to investigate the influence of the timing of cleft palate surgery on speech outcomes and the Data Coordinating Center (DCC) will support the activities of the trial with the provision of administrative, logistical, and biostatistical support for the development, implementation, and successful completion of the trial protocol. To accomplish this objective, the DCC will: 1) actively participate on trial-wide committees;2) manage the information systems required to conduct an international study utilizing a secure study-specific web portal to facilitate randomization, data entry, and communication between the DCC and site coordinators;3) coordinate overall study activities, including scheduling meetings and conference calls, recording and distributing minutes, and preparing study materials;4) arrange for and conduct ongoing training of study staff with respect to data collection, data entry, and trial monitoring;5) conduct central monitoring and conduct yearly site visits, in partnership with the administrative site, to monitor site compliance with Good Clinical Practice guidelines;6) monitor recruitment and timeliness of data acquisition and data entry at sites and carry out quality assurance procedures on all study data;7) track the collection and transfer, of speech, clinical, genetic and audiological data and prepare and oversee distribution of the final ("locked") study data;8) provide statistical expertise throughout the study to include monitoring of the randomization routine, preparation of reports to the Data and Safety Monitoring Board and execute the statistical analysis plan for analysis of final study data;9) prepare manuscripts for publications to disseminate study findings;10) prepare a public web page to provide information (in lay terms) regarding trial findings;and 11) archiving of all relevant source documents so that the trial data can be compared against source data after completion of the trial (e.g. in case of inspection from authorities).
Improving the evidence base for cleft palate surgery will improve the treatment and social integration of affected children, reduce the burden of remedial care that they and their families must endure, and reduce the cost of care associated with cleft palate.