Clinical Trial Software to Aid Children’s Study

By Jon Parham

 Researchers Umit Topaloglu, Ph.D., (left) and William Hogan, M.D., developed software selected for use in the National Children's Study.
Researchers Umit Topaloglu, Ph.D., (left) and William Hogan, M.D., developed software selected
for use in the National Children’s Study.

The UAMS system was one of four selected by the National Children’s Study, with each system to be installed at several study centers. The Arkansas Study Center of the National Children’s Study was awarded a two-year, $3.3 million contract to host the information systems it was using for the study at five other participating universities.

The Arkansas Study Center, based at the UAMS Centers for Children in Lowell in Benton County, is the only Arkansas location tapped to be part of the National Children’s Study.

The UAMS software system will be installed at the Arkansas site and at Case Western Reserve University, the University of California-Davis, the University of Florida at Jacksonville, the University of Texas-Southwestern and Saint Louis University.

“The goal is to compare the four systems to see which components hold the most promise in the long term for collecting and managing the data for the National Children’s Study,” said William Hogan, M.D., associate professor and chief of the Division of Biomedical Informatics in the UAMS College of Medicine that contributed to the development of the open source information management system. “They could pick all of one or parts of multiple systems.”

The National Institutes of Health awarded a $14.4 million contract to the Arkansas Children’s Hospital Research Institute (ACHRI) in 2008 to facilitate Benton County’s involvement in the National Children’s Study. The study will follow a representative national sample of 100,000 children from before birth to age 21.

Study volunteers will be recruited throughout the United States from rural, urban and suburban areas; from all income and educational levels; and from all racial groups. The study will investigate factors influencing the development of such conditions as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma and obesity.

The Arkansas Study Center is being led by Charlotte Hobbs, M.D., Ph.D., director of the Arkansas Center for Birth Defects Research and Prevention at ACHRI and an associate professor in the Department of Pediatrics of the UAMS College of Medicine.

“I am very pleased that the work of Drs. Hogan and Umit Topaloglu is being recognized at a national level within the National Children’s Study,” Hobbs said. “The ability to collect, store and use the incredible amounts of data this study will generate will be critical to our ability to analyze and possibly discover factors influencing disease or medical conditions.

“This award presents the opportunity to demonstrate the abilities of their system and potentially see it adopted as the study expands.”

A team including Topaloglu and others developed the open source components three years ago as part of the Cancer Institute’s participation in the cancer Biomedical Informatics Grid (caBIG) initiative of the National Cancer Institute. Both the National Cancer Institute and Health Care Information and Management Systems Society recognized the UAMS group for its work on the caBIG software.

Hogan said he believed the open source nature of the software made it attractive for the child study. Open source software can be shared and changed – meaning it could be easily adapted for use in collecting and analyzing data, whether it was from cancer clinical trials or child health. The various components, from the clinical trial management system to the patient registry, are modular, so they can function either independently or together as a full system.

A survey tool developed as part of the software will aid the data collection in the child study. Surveys are a large part of the child study, Hogan said, as researchers must collect extensive demographic information about each child and information about living conditions, diet, and other socioeconomic factors that might influence child health..

More recently, the UAMS Translational Research Institute began using the software for studies in its clinical research services core. Creation of the Translational Research Institute was enabled in part by the nearly $20 million Clinical and Translational Science Award to UAMS in 2009.

Hogan said he expects by late September the UAMS software will be installed at the five child study centers selected as part of the contract.

For more information about the Arkansas Study Center or the National Children’s Study, visit ncsbentoncounty.com or call 877-543-7839 (877-KID-STDY).