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DCU expertise manages stroke trials, research

by Cindy Abole
Public Relations
Finding the right talent and expertise to help manage a clinical research project and conduct data management services and statistical analyses is the goal of today’s clinical researchers.
 
At MUSC, clinically-trained health professionals and investigators are quickly discovering the benefits of using highly-skilled services and personnel that are on campus to do the job. MUSC’s Data Coordination Unit (DCU), located in the Department of Biostatistics, Bioinformatics and Epidemiology, provides first-rate clinical research support, plus creates an infrastructure that is needed to maintain quality clinical research trials in today’s competitive arena.
 
The DCU's experience and reputation for excellence led the group to manage and support more than a dozen single and multicenter research projects. Last fall, the DCU landed a five-year, $6.9 million NIH/National Institute of Neurological Disorders and Stroke (NINDS)-funded project to provide statistical and data coordination for two large therapeutic stroke clinical trials.
 
One is the Albumin in Acute Stroke (ALIAS) Trial which will test the effectiveness of albumin as a neuroprotectant in up to 1,800 patients with acute ischemic stroke. The other is the Interventional Management of Stroke (IMS) III that will compare the clinical outcome of intravenous versus intravenous plus intra-arterial delivery of recombinant tissue Plasminogen Activator or tPA, in approximately 900 acute ischemic stroke patients. tPA is currently the only FDA-approved clot-busting drug for ischemic stroke. Each trial will be conducted at approximately 50 clinical sites all over the U.S. and Canada. Both trials expect to begin patient enrollment in April. The DCU provides data management and project coordination and serves as the statistical center for both trials under the guidance of Yuko Palesch, Ph.D., professor in the Department of Biostatistics, Bioinformatics and Epidemiology and the director of the DCU. 
 
“What we provide is more than just a service, it truly is a collaborative effort,” said Palesch, of NIH’s shift towards valuing quality data management, particularly in large studies. “In today’s scheme, principal investigators are expected to provide detailed data management and statistical analysis descriptions in their proposals and the reviewers look for them. The DCU team can provide this expertise from a project’s beginning to end. We collaborate with the investigator to design efficient and cost-effective study and data management plans.”
 
“Clinical trials are not a one-size-fits-all method especially as it relates to managing data collection and statistical analysis,” Palesch said. “Today, on one hand, there is the necessary to move toward an efficient common data manage-ment system, yet on the other hand, there’s a great demand by the investigators to customize technology to help meet a project’s needs. Our programmers, data and project managers strive to understand the study protocol and develop a data management plan that minimizes the burden on the research personnel and maximizes the expertise of our group. All of us at the DCU feel good about the quality of work we provide to our clients.”  
    
What Palesch describes is her team’s development of a secure, user-friendly Internet-based database system called WebDCU. Established in 2004, WebDCU is capable of managing data collection at multiple study sites across the continent. This paperless data management system features several customizable study tools all within one system. It also includes standard modules such as subject registration, randomization, specimen tracking, data quality assurance and reporting, user-training and drug-shipment tracking. The experienced DCU staff works closely with the investigators and research team to develop a plan that ensures proper handling and tracking of all collected data.
 
“By moving to this paperless data management system, it shows that we can be more accurate as well as more time and cost efficient in managing a study,” said Valerie Durkalski, Ph.D., DCU Associate Director, referring to the cost savings from elimination of paper, storage needs and data transfer between study sites.
 
As success with WebDCU progresses, so does the need to introduce the technology to other large scale trials. Department of Psychiatry professor, Mark George, M.D., uses WebDCU in his research. As director of MUSC’s Center for Advanced Imaging Research, George is one of the institution’s busiest clinical researchers. George has experience leading a variety of small local and large multicenter studies. In early 2000, George first used the DCU to help coordinate and manage data for a DoD-funded study on Transcranial Magnetic Stimulation (TMS), examining the effects of TMS on sleep-deprived patients. Currently, George is using WebDCU for a four-year, NIH-funded multisite trial studying TMS as a treatment for depression.
 
“WebDCU provides real transforming work,” said George. “Programmers customized this program and it is entirely web-based. Once a patient is seen, their results can be immediately posted by the site into the WebDCU study database. As the study’s principal investigator, I can look and read the real-time results at any of the study’s locations 24/7. It’s revolutionary for clinical trials.” 
 
The idea of providing high quality data management and coordination research at MUSC remains part of a decadelong effort to offer data management of multicenter clinical studies, project management and other support expertise to MUSC investigators and external parties. First established in 1998 as the Clinical Innovations Group under the MUSC Foundation for Research Development, the group evolved to provide a more focused effort for clinical trials data management and statistics. Later, with the support of the provost and department chair, they relocated to the Department of Biostatistics, Bioinformatics and Epidemiology to support its affiliated faculty and gain more exposure from its collaborator base.
 
In 2004, it was renamed as the Data Coordination Unit. Unlike many industry data management providers, the DCU not only supports the research projects but also collaborates on an ongoing basis with the investigators to provide a system that continuously addresses the appropriate research questions and needs of the study. 
 
To accomplish its objectives, the DCU has built an experienced staff with expertise in every aspect of trial design and conduct. They are from the fields of biostatistics, computer programming, clinical trials methodology, data management and analysis, and project management and administration. The team is adept at managing large amounts of data, understanding scientific issues, maintaining multiple databases, assuring quality control and securely disseminating study information to the appropriate parties.  
 
“To achieve funding for the ALIAS and IMS III stroke trials is a major accomplishment for Dr. Palesch and the DCU team,” said Barbara Tilley, Ph.D., chair of the Department of Biostatistics, Bioinformatics and Epidemiology. “The DCU group has succeeded in obtaining funding for two different but large multi-center stroke trials at the same time, which is unprecedented. Usually an institution is awarded NINDS funding for one trial at a time. Dr. Palesch was involved in both projects from its planning stages. What NINDS has done is pull both studies together and placed it under one statistical center to handle their entire data management effort.”      
 
The DCU team benefits from contribution and expertise by other faculty members and students in the Department. In particular, the environment facilitates discussion of statistical issues with colleagues working with the Department’s Collaborative Unit or brainstorming with graduate students and clinical professionals who participate in the Master of Science in Clinical Research program and MUSC’s new Southeastern Predoctoral Training in Clinical Research participants.
    
Today, the DCU has collaborated on projects in a wide range of clinical research areas including depression, stroke, alcohol abuse, Parkinson’s disease, digestive disease, scleroderma, and other research. The team continues to support the data coordinating activities of investigators conducting government and industry-funded, large scale epidemiological research projects and clinical trials at MUSC and at other institutions.
  

Web DCU creator creates niche for collaboration

As a student back in China, Wenlee Zhao, Ph.D., was always searching for a chance to merge his love for engineering and computers with human health.
 
In the mid-1990s after earning degrees in mechanical engineering, Zhao became a student at MUSC’s Department of Biostatistics, Bioinformatics and Epidemiology and eventually worked for the Clinical Innovations Group. As his experience with collecting and managing data information with computer systems grew, so did his proficiency for managing information for single and multi-site trials.
 
“We quickly realized the need to utilize current technology featuring computers and the Internet to gather and manage data,” Zhao said, of the renamed Data Coordination Unit after being assumed under the Department of Biostatistics, Bioinformatics and Epidemiology. “We needed to move quickly towards Web technology to be competitive with other institutions and industry.”
    
Traditionally, data entry coordinators would mail data to study coordinating groups to input information into the computer. Problems may arise with inaccuracies or other data clarification issues that could slow down the process even further jeopardizing a study’s efficacy and results. In 2001, Zhao began working on an early version of Web DCU, a new, customizable web-based technology, which originated from a simple project in the Department of Psychiatry to collect data. Zhao tested a full-scale, web-based version of Web DCU in 2004 featuring psychiatry researcher Mark George’s, M.D., multisite Transcranial Magnetic Stimulation trial.
    
Since then, the Web DCU was used successfully in dozens of trials. Zhao and DCU team of data managers,  computer programmers, and information systems specialists are currently working on other stroke psychiatry, rheumatology and other research trials.
 
“Because of our experience with other projects, we’ve developed an ability to create flexible systems to help manage data information for different types of projects. We know our capabilities and limits and take pride in our accomplishments and collaborations,” Zhao said.

For information on the DCU visit https://dcu.musc.edu/ or contact Palesch at paleschy@musc.edu or Durkalski at durkalsv@musc.edu.
 

Friday, March 24, 2006
Catalyst Online is published weekly, updated as needed and improved from time to time by the MUSC Office of Public Relations for the faculty, employees and students of the Medical University of South Carolina. Catalyst Online editor, Kim Draughn, can be reached at 792-4107 or by email, catalyst@musc.edu. Editorial copy can be submitted to Catalyst Online and to The Catalyst in print by fax, 792-6723, or by email to catalyst@musc.edu. To place an ad in The Catalyst hardcopy, call Island papers at 849-1778, ext. 201.