Clinical Trial and Data Coordination Section

 

Mission:  To facilitate quality clinical trials by providing the research community with comprehensive trial design, data and project management, and analysis services that help move innovative research studies efficiently and rigorously from the initial proposal through execution, analysis and dissemination.

 

Description:  The Department of Biostatistics Clinical Trials and Data Coordination Section offers comprehensive study design, data and project management, and analysis support services to investigators conducting clinical trials using a team approach. We assist with studies supported by federal and foundation grants and industry contracts, including investigator-initiated trials.  We offer a team of individuals with experience in the design and conduct of multicenter clinical trials.

 

Functions:

Study Design

  •  Assistance in the development of the study hypotheses and outcomes.
  •  Optimal study design identification, including both frequentist and Bayesian approaches. 
  •  Implementation of innovative study designs including Bayesian designs and fully Bayesian adaptive designs.
  •  Development of new study designs that provide maximum efficiency in the presence of study parameters, restrictions and assumptions.
  •  Protocol preparation and implementation.

Statistical Methods & Analysis

  •  Development and application of innovative statistical methods unique to the challenges of the on-going studies in the section.
  •  Report generation for sponsors and government agencies.
  •  Interim analyses.
  •  Assistance to researchers for preparation of manuscripts and presentations.

Data Capture and Management

 

CRIS (Comprehensive Research Information System powered by Velos eResearch) is a secure web-based Clinical Information Management System such that data and protocol information can be entered efficiently and in a standardize format compliant with NIH reporting standards. The comprehensive clinical trials management system supports participant recruitment, study monitoring, trial design, protocol management, and data safety monitoring; case report form construction and dissemination; integration of tissue and clinical information; clinical trial execution and query management; and integration with third party clinical systems. We have designed a web-based software application utilizing the Velos eResearch system. Our Comprehensive Research Information System (CRIS) provides capabilities to:

  • Create, maintain, and edit participant data, such as demographics, labs, medications, diagnosis, clinical history, and tissue samples;
  • Create and maintain research protocols;
  • Track the development of study protocols, versions, amendments, and IRB approvals/renewals;
  • Create participant screening and enrolling criteria;
  • Create and disseminate case report forms for clinical trials and outcomes studies;
  • Create and maintain tissue banks and associate tissue samples with other clinical data at both participant and study levels;
  • Create participant schedules and record clinical results and participant status in research protocols;
  • Create user and multi-organization research networks;
  • Record, maintain, and report adverse events; 10) store and report on all participant- and study-level clinical data;
  • Conduct study queries and generate standard and ad hoc clinical reports;
  • Export clinical data to third party analytical tools, such as SAS and Excel.
  • Protocol-specific CRF development, complete with testing and appropriate implementation.
  • Validation testing.
  • Implementation of quality control/assurance procedures.

The system includes in its software programming to maintain compliance with 21 CFR Part 11 as well as various industry and federal standards. The system can support multi-center, cooperative group and investigator-initiated research through advanced technology and security features, all contained in one comprehensive environment. Through utilization of this comprehensive system great improvements in the research productivity, efficiency, collaboration and integrity of data can be achieved. We have designed the Comprehensive Research Information System using the Velos eResearch product as it allows us to design and develop an extensive and custom application while maintaining a data standard shared by other institutions.

Click here for the CRIS Training Request Form

 

Administration/Regulatory

  • Financial management services.
  • Coordination of study functions, including: travel and meeting arrangements, teleconferences, site payment. 
  • Site initiating/training expertise.
  • Site monitoring.

Education

  • Foster the use of innovative statistical methods for the design and implementation of multicenter clinical trials.
  • Provide educational opportunities to students and researchers at the KUMC regarding the design and analysis of multicenter clinical trials, through both formal and informal venues.

For questions regarding the section, please contact Dr. Matthew Mayo, Professor and Founding Chair, Department of Biostatistics 913-588-4703.

For analytical services, please submit your project or grant by clicking the Register Now link.

Last modified: Apr 08, 2014
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