Since 1997, the National Institute of Child Health and Human Development (NICHD) and the National Institute on Deafness and Other Communication Disorders (NIDCD) has provided funding for a Network on the Neurobiology and Genetics of Autism: Collaborative Programs of Excellence in Autism (CPEA). The CPEA network of 10 multidisciplinary projects is being extended for an additional five years to continue studies of genes, brain structure, brain function and behavior and the clinical course of autism. Three separate entities (DMSTAT, Inc., the Boston University Statistics and Consulting Unit at the College of Arts and Sciences and the Department of Biostatistics at the Boston University School of Public Health) have formed a group, DMSTAT/BU, proposing to collaborate with the CPEA network and to serve as its centralized data coordinating center (DCC). Our multi-disciplinary team of biostatisticians, epidemiologists, statistical geneticists, project managers, programmers and data managers can effectively and efficiently serve the ongoing and changing needs of the CPEA network. The primary goal of DMSTAT/BU is to provide integrated support to all CPEA project staff on two fronts: 1) consistent, efficient, cost-effective and high quality data management, and 2) biostatistical expertise in study design, randomization schemes, matching procedures, statistical genetics and multivariable analysis. DMSTAT/BU will assist project staff in the following areas: study design and protocol development, innovative processes to streamline data collection and increase data quality, administrative management, staff training, study monitoring, regulatory compliance, statistical design, analysis and reporting, and study documentation, in addition to applying our proven data management and statistical analysis procedures, DMSTAT/BU will develop a website for the network which will serve as the backbone of the study infrastructure. The website will have administrative (e.g., e-mail links, meeting information, personnel contact information, project documentation, expense tracking) and data collection (distributed tracking and data entry systems) components. A reporting module in the website will make all of the administrative and data management information accessible to authorized members of the CPEA network. The team we have assembled has the requisite experience to effectively serve the needs of the CPEA network. The qualities that set us apart from our competitors are: innovation in streamlining and organizing processes, our abilities to educate and communicate with study staff at all levels, the breadth and depth of our analytic and statistical knowledge, our commitment to integrity in all aspects of data management, and our outstanding track record on studies of similar size and scope.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HD045023-01
Application #
6690075
Study Section
Special Emphasis Panel (ZHD1-DSR-A (15))
Program Officer
Kau, Alice S
Project Start
2003-09-26
Project End
2008-05-31
Budget Start
2003-09-26
Budget End
2004-05-31
Support Year
1
Fiscal Year
2003
Total Cost
$1,052,763
Indirect Cost
Name
Dm-Stat, Inc.
Department
Type
DUNS #
009882820
City
Malden
State
MA
Country
United States
Zip Code
02148
King, Bryan H; Dukes, Kimberly; Donnelly, Craig L et al. (2013) Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial. JAMA Pediatr 167:1045-52
Hallett, Victoria; Lecavalier, Luc; Sukhodolsky, Denis G et al. (2013) Exploring the manifestations of anxiety in children with autism spectrum disorders. J Autism Dev Disord 43:2341-52
Scahill, Lawrence; McCracken, James T; Bearss, Karen et al. (2012) Design and subject characteristics in the federally-funded citalopram trial in children with pervasive developmental disorders. J Autism Dev Disord 42:432-40
Nord, Alex S; Roeb, Wendy; Dickel, Diane E et al. (2011) Reduced transcript expression of genes affected by inherited and de novo CNVs in autism. Eur J Hum Genet 19:727-31
King, Bryan H; Hollander, Eric; Sikich, Linmarie et al. (2009) Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Arch Gen Psychiatry 66:583-90
Tanaka, James W; Curran, Tim; Sheinberg, David L (2005) The training and transfer of real-world perceptual expertise. Psychol Sci 16:145-51