NIMH Clinical Data Management and Support

Client: National Institute on Mental Health (NIMH), NIH

Client/study focus and needs: We supported multiple clinical studies sponsored by NIMH under this contract, including the Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (MTA). This multisite study was the first to evaluate the long-term safety and relative effectiveness of leading treatments for attention-deficit hyperactivity disorder (ADHD) administered for a time period of up to 14 months compared to routine community care. Participants in the study were followed for up to 14 years post treatment.

Our customized approach: We created a customized clinical database management system (Smart Study™©), developed a secure website to house study-related materials, and trained MTA sites on the customized Smart Study™© application. In addition, we developed and distributed a manual of operating procedures; finalized, produced, and distributed data collection instruments; obtained and verified aggregate data from NIMH; managed quality assurance; conducted statistical analyses; and produced reports. Providing quality oversight and a standardized approach to data collection and storage enabled us to enhance data integrity, efficiently analyze the data, and produce reports and final study datasets covering the life of the longitudinal study in a timely manner.

Services: Clinical study coordination, monitoring, data management, statistical programming, quality assurance

Results: Study participants were contacted for follow-up from 6 through 16 years of age, at two-year intervals. A total of 868 participants were followed with over 75% completing follow-up through the 16th year. Our comprehensive approach to data management enabled us to provide NIMH with data analysis and reports that addressed the safety and effectiveness of these ADHD treatments longitudinally, providing a picture of the natural history of participants with ADHD.